Depression, AnxietyNCT04719780
An Attachment Based Approach for Anxiety and Depression
A study testing Emotionally Focused Therapy for Individuals and Self-Help CBT Training in people with Depression, Anxiety, run by Saint Paul University at 3 sites in 2 countries.
Trial summary
The purpose of the current study is to examine the efficacy of Emotionally Focused Therapy for Individuals (EFIT) as a treatment for depression and anxiety. It is formulated as a trans-diagnostic treatment in line with the call for more transdiagnostic approaches to treat depression and anxiety given the many… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Emotionally Focused Therapy for Individuals and Self-Help CBT Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Dec 2019to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of Major Depressive Disorder with co-morbid symptoms of anxiety
- Inclusion cut offs: Participants must score in the mild-to severe range on BDI-II and mild-moderate on the BAI
- At least 18 years old
Who cannot join
- Psychotropic medication change in 6 weeks prior to enrollment or anticipated during the study period (this allows us to include people who are taking a medication but mitigates the risk of medication changes as a problematic factor; assessed in phone screen)
- Current DSM diagnosis of bipolar disorder, schizophrenia-spectrum disorder, PTSD, eating disorder, personality disorder, or substance abuse or dependence
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Vancouver Island Centre for Emotionally Focused Therapy
Nanaimo, British Columbia, V9V 1A3
Saint Paul University
Ottawa, Ontario, K1S 1C4
United States1 site
University of Colorado Denver
Denver, Colorado, 80204
About this study
Official title: A Randomized Controlled Trial of an Attachment Based Approach for Anxiety and Depression, Emotionally Focused Individual Therapy
The purpose of the current study is to examine the efficacy of Emotionally Focused Therapy for Individuals (EFIT) as a treatment for depression and anxiety. It is formulated as a trans-diagnostic treatment in line with the call for more transdiagnostic approaches to treat depression and anxiety given the many similarities in the underlying psychological and emotional factors of these disorders, the high levels of co-morbidity, and the preliminary success of transdiagnostic treatment approaches. EFIT has been formulated as an attachment-based alternative to current cognitive transdiagnostic approaches. The strong evidence for insecure attachment as an underlying factor in psychopathology, especially depression and anxiety, positions this theory well as a foundational principle to support psychotherapy for these conditions. EFIT has been formulated for the first time this year in the book that will serve as the therapy manual for this study. The current study aims to examine EFIT outcomes as compared to a control group (a wait-list control followed by online CBT intervention after the wait period). In particular, this research project aims to distinguish differences in initial and follow-up outcomes between EFIT versus control, and demonstrate significant changes in attachment/emotions and mechanisms of change across EFIT sessions. The primary hypotheses are outlined below.
Read the detailed description
PROCEDURES
Recruitment Participants are recruited from the general population of individuals self-identifying as having symptoms of depression and/or anxiety in each study site (Ottawa, Denver, Victoria). Study advertisements are posted and circulated through post-secondary institutions, online, and within psychotherapy treatment centres. Participants experiencing depression and/or anxiety are invited to contact the research coordinator of the project via the email listed on recruitment material. All interested participants receive a telephone screen by research research assistants to assess potential eligibility. Participants who are deemed potentially eligible are informed that they will be contacted by an assessor to be invited for an initial study assessment session to determine final eligibility.
Baseline assessment Assessors are individuals with clinical experience in psychotherapy or counselling at each of the study sites. Informed consent is reviewed and participants have the opportunity to have all their questions and concerns addressed. Assessors administer the diagnostic criteria modules of the ADIS-5 during this session. Assessments take place either within the private practice locations at each study site or the university offices of the investigators in a research session lasting approximately 1-2 hours. During the pandemic while it is not safe to meet in person, secure encrypted video call platforms are used to hold these sessions. Responses are evaluated by the assessors' supervisors, at which point final eligibility is determined. The assessments and therapy take place either within the private practice locations at each study site as specified or the university offices of the co-investigators, or online using a secure encrypted video call platform when it is unsafe to meet for in-person sessions due to the pandemic. After completion of the baseline assessment session, eligible participants are given access to an online questionnaire to complete at their own convenience. After completion of the questionnaire, participants are randomly assigned to study condition.
Random assignment Once participants have been deemed eligible to take part, and have completed the baseline questionnaire, they are randomly assigned to the EFIT (treatment) condition or the waitlist plus online CBT (control group) condition by the research co-ordinator. A list of numbers (i.e., 1-40 for Ottawa, 1-28 for Victoria, and 1-20 for Denver) are generated for each city, reflecting the total number of EFIT and control clients for that city. Within those groups, a separate randomized list (i.e., 20 total numerical values for Ottawa, 14 for Victoria, and 10 for Denver) is generated using Research Randomizer, an online tool for random assignment that has been used in previous RCT studies. As participants are deemed eligible, they are added onto the list and their number will determine whether they will take part in either the EFIT intervention or the control group.
Interventions:
EFIT Treatment Group Twenty-two experienced EFT therapists trained in the EFIT model will provide 15 sessions of EFIT treatment to approximately 2 clients each. Therapy will be carried out in private practices or the university offices of researchers located in each of the study sites, or online using a secure encrypted video call platform when not possible to meet in person due to the pandemic. Each site is associated with an EFT centre: Ottawa Institute of Couple and Family Therapy in Ottawa, Centre for EFT Vancouver Island in Victoria, and Colorado Centre for EFT in Denver. Study therapists will receive an average of 1 hour of supervision per week in groups of 3-4 therapists. Each therapy session will be video recorded and treatment fidelity will be confirmed through the coding of video tapes. After each therapy session, therapists will ask participants to complete a brief online questionnaire that takes approximately 10 minutes to complete. The link to the online questionnaire will be sent to each therapist by the research co-ordinator.
Wait-List plus online CBT Control Group Participants randomly assigned to the wait-list control group will wait 15 weeks, following which time they will be given an online transdiagnostic cognitive-behavioural treatment (MoodGym) for depression and anxiety that has been empirically validated after they have completed the 15-week wait period. They will be given access to complete 15 weeks of the online intervention. These participants will also be requested to complete a brief online questionnaire on a weekly basis - this questionnaire is identical to the questionnaire given to EFIT participants after each therapy session with the exception that it does not include the Working Alliance Inventory (WAI) or the Post-session Resolution Questionnaire (PSRQ) as these questionnaires are only relevant to therapy sessions.
- Conditions
- Depression, Anxiety
- Being tested
- Emotionally Focused Therapy for Individuals, Self-Help CBT Training
- Keywords
- Randomized control trial, Emotionally focused therapy, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotionally Focused Therapy for IndividualsBehavioural
Emotionally Focused Therapy for Individuals (EFIT) is formulated as a transdiagnostic treatment to treat depression and anxiety, adapted from the well-studied Emotionally Focused Therapy. EFIT has been formulated as an attachment-based alternative to current cognitive approaches (e.g., Cognitive Behavioural Therapy). The strong evidence for insecure attachment as an underlying factor in psychopathology, especially depression and anxiety, positions this theory well as a foundational principle to support psychotherapy for these conditions.
Self-Help CBT TrainingBehavioural
Also called MoodGym
Individuals in the Waitlist Control Group will receive access to MoodGym, a self-help online program that helps teach CBT interventions. This access will last 15 weeks and is self-driven, meaning participants proceed through the program at their own pace.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control Group (CBT) | Active comparator | Individuals in this arm (n=44) are provided with a transdiagnostic cognitive-behavioural treatment for depression and anxiety (MoodGym) that has been empirically validated after their 15-week wait period is complete. Receives: Behavioral: Self-Help CBT Training |
| EFIT Group | Experimental | Individuals in the EFIT Group (n=44) will receive 12-15 sessions of EFIT in order to treat their symptoms of depression and anxiety. Receives: Behavioral: Emotionally Focused Therapy for Individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)
The ADIS-5 is a structured interview intended to help clinicians diagnose psychological disorders based on DSM-5 criteria. The ADIS-5 also allows for differential diagnosis and has been widely used in clinical research. Assessors will administer the ADIS-5 and determine whether or not the participants the criteria for a diagnosis of anxiety and/or depression, and to assess change upon completion of the 15-week intervention.
Measured: Change from baseline to completion of the 15 week intervention.
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)
The ADIS-5 is a structured interview intended to help clinicians diagnose psychological disorders based on DSM-5 criteria. The ADIS-5 also allows for differential diagnosis and has been widely used in clinical research. Assessors will administer the ADIS-5 and determine whether or not the participants the criteria for a diagnosis of anxiety and/or depression, and to assess change at post 15-week wait period.
Measured: Change from baseline to completion of the 15 week wait period.
Beck Depression Inventory-2 (BDI-2)
The Beck Depression Inventory-2 is a 21-item self-report questionnaire used to assess the severity of depressive symptoms (e.g., sadness, guilt, crying, suicidal thoughts, etc.). Participants are presented with a list of themes and are asked to choose a statement that best fits their mood over the past two weeks. Each statement has a corresponding numerical value. The sum all statements are calculated for scoring purposes. A score of 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and a score above 29 indicates severe depression. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI after session 5 and 7.
Measured: Change from baseline to week 5, week 7, completion of 15-week wait period (control condition), and 3, 6, 9 and 12 months following completion of the wait-period.
Beck Depression Inventory-2 (BDI-2)
The Beck Depression Inventory-2 is a 21-item self-report questionnaire used to assess the severity of depressive symptoms (e.g., sadness, guilt, crying, suicidal thoughts, etc.). Participants are presented with a list of themes and are asked to choose a statement that best fits their mood over the past two weeks. Each statement has a corresponding numerical value. The sum all statements are calculated for scoring purposes. A score of 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and a score above 29 indicates severe depression. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI after session 5 and 7.
Measured: Change from baseline to week 5, week 7, completion of 15-week intervention, and 3, 6, 9 and 12 months following the intervention.
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory is a 21-item self-report questionnaire used to assess common symptoms of anxiety (e.g., rapid heartbeat, sweating, numbness, trembling, etc.). Participants are presented with a list of common symptoms of anxiety and are asked to note how much they experienced each over the past week from a four item Likert scale ("not at all", "mildly", "moderately", and "severely"). The total score is calculated by finding the sum of all 21 items; a score of 0-21 indicated low anxiety, 22-35 indicates moderate anxiety, and a score of 36 and above indicates potentially concerning levels of anxiety. Both of the Beck inventories used in this study have been widely used in clinical research and possess good reliability and validity. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI-2 after session 5 and 7.
Measured: Change from baseline to week 5, week 7, and completion of 15-week wait period (control condition) and at 3, 6, 9, and 12 months after completing the wait-period
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory is a 21-item self-report questionnaire used to assess common symptoms of anxiety (e.g., rapid heartbeat, sweating, numbness, trembling, etc.). Participants are presented with a list of common symptoms of anxiety and are asked to note how much they experienced each over the past week from a four item Likert scale ("not at all", "mildly", "moderately", and "severely"). The total score is calculated by finding the sum of all 21 items; a score of 0-21 indicated low anxiety, 22-35 indicates moderate anxiety, and a score of 36 and above indicates potentially concerning levels of anxiety. Both of the Beck inventories used in this study have been widely used in clinical research and possess good reliability and validity. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI-2 after session 5 and 7.
Measured: Change from baseline to week 5, week 7 and completion of 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
Outcome Questionnaire-30.2
The Outcome Questionnaire-30.2 is a brief 30-item instrument intended to measure client progress before, during, and following clinical interventions. This questionnaire is was adapted from the OQ-45, is highly sensitive to session-by-session changes, and possesses high levels of reliability and validity. Over the course of the study, this questionnaire will be repeatedly administered in order to monitor participants' progress through the EFIT and waitlist conditions. This questionnaire will also be administered during the 4 follow-up time points.
Measured: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
Outcome Questionnaire-30.2
The Outcome Questionnaire-30.2 is a brief 30-item instrument intended to measure client progress before, during, and following clinical interventions. This questionnaire is was adapted from the OQ-45, is highly sensitive to session-by-session changes, and possesses high levels of reliability and validity. Over the course of the study, this questionnaire will be repeatedly administered in order to monitor participants' progress through the EFIT and waitlist conditions. This questionnaire will also be administered during the 4 follow-up time points.
Measured: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)
The Patient-Reported Outcomes Measurement Information System-Anxiety scale is an 8-item tool designed to measure participants' self-reported anxiety symptoms over the past week. Participants are asked to respond to eight anxiety-related statements on a 5-point Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always).
Measured: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)
The Patient-Reported Outcomes Measurement Information System-Anxiety scale is an 8-item tool designed to measure participants' self-reported anxiety symptoms over the past week. Participants are asked to respond to eight anxiety-related statements on a 5-point Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always).
Measured: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)
The Patient-Reported Outcomes Measurement Information System-Depression scale is an 8-item scale used to measure participants' self-reported depression symptoms over the past week. Participants are asked to respond to eight depression-related statements on the same 5-point Likert scale as the PROMIS-Anxiety measure.
Measured: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)
The Patient-Reported Outcomes Measurement Information System-Depression scale is an 8-item scale used to measure participants' self-reported depression symptoms over the past week. Participants are asked to respond to eight depression-related statements on the same 5-point Likert scale as the PROMIS-Anxiety measure.
Measured: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
Secondary outcomes (22)
Childhood Trauma Questionnaire-Short Form
It is a 28-item self-report scale that measures self-reported occurrence of maltreatment in childhood and adolescence. Participants will be asked to answer statements with a corresponding Likert scale value. A total of five factors are included in this measure: sexual abuse, physical abuse, emotional abuse, emotional neglect, and physical neglect; each factor has its own cut-off score.
Measured: Baseline
Trauma Symptom Inventory-2
The TSI-2 evaluates post-traumatic stress symptomatology and other long-term effects of trauma (e.g., dissociation, insecure attachment styles, somatization, etc.) on a 4-point Likert Scale. Participants are asked to rate 136 brief statements based on their level of agreement.
Measured: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Trauma Symptom Inventory-2
The TSI-2 evaluates post-traumatic stress symptomatology and other long-term effects of trauma (e.g., dissociation, insecure attachment styles, somatization, etc.) on a 4-point Likert Scale. Participants are asked to rate 136 brief statements based on their level of agreement.
Measured: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Experiences in Close Relationships Questionnaire (ECR)
The Experiences in Close Relationships Questionnaire is a 12 item questionnaire that measures individuals' attachment to romantic partners; the current study, however, received special permission to revise the wording and change "romantic partner" to "loved one". The ECR contains two scales, each containing 18 items: attachment anxiety, and attachment avoidance. The questionnaire is scored on a 7-point scale (1=strongly disagree, 7=strongly agree).
Measured: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
Experiences in Close Relationships Questionnaire (ECR)
The Experiences in Close Relationships Questionnaire is a 12 item questionnaire that measures individuals' attachment to romantic partners; the current study, however, received special permission to revise the wording and change "romantic partner" to "loved one". The ECR contains two scales, each containing 18 items: attachment anxiety, and attachment avoidance. The questionnaire is scored on a 7-point scale (1=strongly disagree, 7=strongly agree).
Measured: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
Reflective Function Questionnaire-8 (RFQ)
The Reflective Function Questionnaire-8 is the short form version of the longer 54-item measure. This questionnaire is used to measure the degree of certainty the participants experience regarding their awareness of their own and others' mental states. Questions on the RFQ are measured on a 7-point Likert scale (1=strongly disagree, 7=strongly agree).
Measured: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Reflective Function Questionnaire-8 (RFQ)
The Reflective Function Questionnaire-8 is the short form version of the longer 54-item measure. This questionnaire is used to measure the degree of certainty the participants experience regarding their awareness of their own and others' mental states. Questions on the RFQ are measured on a 7-point Likert scale (1=strongly disagree, 7=strongly agree).
Measured: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Inventory of Interpersonal Problems-32
The Inventory of Interpersonal Problems-32 is a self-report questionnaire that identifies participants' sources of interpersonal distress generally.. The IIP-32 is a short form of the original 64-item measure. For the first 20 items, participants are asked to rate their level of difficulty with diverse situations on a 5-point Likert scale (0=not at all, 5=extremely). For the remaining items, participants are asked to rate "things [they] do too much" (e.g., please others) on a similar scale. The IIP has been used in psychotherapy sessions wherein clients and therapists complete the measure in order to focus on specific interpersonal difficulties experienced by the client.
Measured: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Inventory of Interpersonal Problems-32
The Inventory of Interpersonal Problems-32 is a self-report questionnaire that identifies participants' sources of interpersonal distress generally.. The IIP-32 is a short form of the original 64-item measure. For the first 20 items, participants are asked to rate their level of difficulty with diverse situations on a 5-point Likert scale (0=not at all, 5=extremely). For the remaining items, participants are asked to rate "things [they] do too much" (e.g., please others) on a similar scale. The IIP has been used in psychotherapy sessions wherein clients and therapists complete the measure in order to focus on specific interpersonal difficulties experienced by the client.
Measured: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Difficulties in Emotion Regulation Scale
The Difficulties in Emotion Regulation Scale is a 32-item questionnaire used to measure participants' difficulties with emotion regulation. The DERS contains six subscales: non-acceptance of emotional responses, difficulty engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Participants are asked to indicate how often the 32 presented statements apply to them. Items are scored on a 5-point Likert scale (1=almost never 0-10%, 5=almost always 91-100%).
Measured: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Difficulties in Emotion Regulation Scale
The Difficulties in Emotion Regulation Scale is a 32-item questionnaire used to measure participants' difficulties with emotion regulation. The DERS contains six subscales: non-acceptance of emotional responses, difficulty engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Participants are asked to indicate how often the 32 presented statements apply to them. Items are scored on a 5-point Likert scale (1=almost never 0-10%, 5=almost always 91-100%).
Measured: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Leuven Affect and Pleasure Scale
The Leuven Affect and Pleasure Scale instrument asks participants to indicate the extent to which they experienced 16 feelings and emotionally-saturated situations (e.g., looking forward to something). Participants are provided with a 10-point Likert scale (0=not at all, 10=very much).
Measured: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Leuven Affect and Pleasure Scale
The Leuven Affect and Pleasure Scale instrument asks participants to indicate the extent to which they experienced 16 feelings and emotionally-saturated situations (e.g., looking forward to something). Participants are provided with a 10-point Likert scale (0=not at all, 10=very much).
Measured: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Rosenberg Self-Esteem Scale
The Rosenberg Self-Esteem Scale is a 10-item instrument that is used to measure positive and negative feelings relating to self-worth. Items are scored on a 4-point Likert scale (1=strongly agree, 4=strongly disagree). In order to score responses, researchers are advised to reverse score items 2, 5, 6, 8, and 9 before summing participants' total scores. Higher scores on the scale indicate higher levels of self-esteem.
Measured: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Rosenberg Self-Esteem Scale
The Rosenberg Self-Esteem Scale is a 10-item instrument that is used to measure positive and negative feelings relating to self-worth. Items are scored on a 4-point Likert scale (1=strongly agree, 4=strongly disagree). In order to score responses, researchers are advised to reverse score items 2, 5, 6, 8, and 9 before summing participants' total scores. Higher scores on the scale indicate higher levels of self-esteem.
Measured: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Patient-Reported Outcomes Measurement Information System-Meaning (PROMIS Meaning)
The Patient-Reported Outcomes Measurement Information System-Meaning instrument is an 8-item questionnaire intended to evaluate individuals' sense of purpose and meaning in life. Participants are asked to rate their level of agreement with eight statements based on a 5-point Likert scale (1=strongly disagree, 5=strongly agree).
Measured: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Patient-Reported Outcomes Measurement Information System-Meaning (PROMIS Meaning)
The Patient-Reported Outcomes Measurement Information System-Meaning instrument is an 8-item questionnaire intended to evaluate individuals' sense of purpose and meaning in life. Participants are asked to rate their level of agreement with eight statements based on a 5-point Likert scale (1=strongly disagree, 5=strongly agree).
Measured: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Multi-dimensional Assessment of Interoceptive Awareness
The Multi-dimensional Assessment of Interoceptive Awareness is a 37-item questionnaire that assesses interoceptive body awareness, a key element of emotion regulation. The measure consists of 8 subscales: Noticing, Not-distracting, Not-worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening and Trusting. Higher scores indicate better interoceptive awareness aspects of affect regulation.
Measured: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Multi-dimensional Assessment of Interoceptive Awareness
The Multi-dimensional Assessment of Interoceptive Awareness is a 37-item questionnaire that assesses interoceptive body awareness, a key element of emotion regulation. The measure consists of 8 subscales: Noticing, Not-distracting, Not-worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening and Trusting. Higher scores indicate better interoceptive awareness aspects of affect regulation.
Measured: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Post Session Resolution Questionnaire (PSQR)
The Post Session Resolution Questionnaire is a measurement tool intended to evaluate the fit of session topics to participants' established therapeutic goals. The questionnaire also allows participants to rate how much they thought a clinical session allowed them to progress towards the resolution of their presenting concerns. Three our of the four items in the PSQR operate on a 5-point Likert scale, the fourth item uses a 7-point scale.
Measured: Weekly for 15 weeks of the experimental condition
Working Alliance Inventory
The Working Alliance Inventory is 12-item clinical tool which measures three key features of the therapeutic alliance: 1) agreement on tasks for therapy, 2) agreement on therapeutic goals, and 3) the development of a strong therapeutic relationship. Participants are presented with a list of statements and are asked to rate the frequency with which these statements reflect the therapeutic alliance they share with their therapist. A 5-point Likert scale is used to rate the participants' perceptions of their therapeutic alliance.
Measured: Weekly for 15 weeks of the experimental condition
Sociodemographic Questionnaire
This questionnaire collects participants' demographic information, such as age, gender, location, income, marital status, etc.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start9 Dec 2019
- Primary completion1 Apr 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomized controlled trial (RCT) carried out across three study sites (Ottawa, Denver, Victoria). We will have two study groups, treatment (n=44) and wait-list control (n=44). The wait-list control will be given an online transdiagnostic cognitive-behavioural treatment for depression and anxiety that has been empirically validated. The treatment condition group will be provided 12-15 sessions of Emotionally Focused Therapy for Individuals. Approximately 22 experienced EFT therapists will be given training in EFIT and will provide treatment to 2-3 clients each. Therapy will be carried out in person and/or online.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Paul University
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Excellence in Emotionally Focused Therapy
- Responsible party
- Principal investigator, Stephanie Wiebe, Saint Paul University
- Investigators
- Stephanie Wiebe, PhD, Principal investigator, Saint Paul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719780
- Sponsor's protocol ID
- 1360.9/19
- Status last verified
- Feb 2024
- First submitted
- 10 May 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
PubMed 28768327Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199Demyttenaere K, Mortier P, Kiekens G, Bruffaerts R. Is there enough "interest in and pleasure in" the concept of depression? The development of the Leuven Affect and Pleasure Scale (LAPS). CNS Spectr. 2019 Apr;24(2):265-274. doi: 10.1017/S1092852917000578. Epub 2017 Nov 9.
PubMed 29117870Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
PubMed 27392018Horowitz LM, Rosenberg SE, Baer BA, Ureno G, Villasenor VS. Inventory of interpersonal problems: psychometric properties and clinical applications. J Consult Clin Psychol. 1988 Dec;56(6):885-92. doi: 10.1037//0022-006x.56.6.885. No abstract available.
PubMed 3204198Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
PubMed 23133619Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
PubMed 9881538Wiebe SA, Johnson SM, Allan R, Campbell TL, Greenman PS, Fairweather DR, Ismail M, Tasca GA. A randomized controlled trial of emotionally focused individual therapy (EFIT) for depression and anxiety. Psychotherapy (Chic). 2025 Sep;62(3):414-423. doi: 10.1037/pst0000586. Epub 2025 Jul 10.
PubMed 40638305
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Attachment Based Approach for Anxiety and Depression, Emotionally Focused Individual Therapy
- ClinicalTrials.gov ID
- NCT04719780
- Acronym / sponsor ID
- 1360.9/19
- Conditions
- Depression, Anxiety
- Keywords
- Randomized control trial, Emotionally focused therapy, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Saint Paul UniversityUniversity, hospital or other
- Collaborators
- International Centre for Excellence in Emotionally Focused Therapy
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to examine the efficacy of Emotionally Focused Therapy for Individuals (EFIT) as a treatment for depression and anxiety. It is formulated as a trans-diagnostic treatment in line with the call for more transdiagnostic approaches to treat depression and anxiety given the many similarities in the underlying psychological and emotional factors of these disorders, the high levels of co-morbidity, and the preliminary success of transdiagnostic treatment approaches. EFIT has been formulated as an attachment-based alternative to current cognitive transdiagnostic approaches. The strong evidence for insecure attachment as an underlying factor in psychopathology, especially depression and anxiety, positions this theory well as a foundational principle to support psychotherapy for these conditions. EFIT has been formulated for the first time this year in the book that will serve as the therapy manual for this study. The current study aims to examine EFIT outcomes as compared to a control group (a wait-list control followed by online CBT intervention after the wait period). In particular, this research project aims to distinguish differences in initial and follow-up outcomes between EFIT versus control, and demonstrate significant changes in attachment/emotions and mechanisms of change across EFIT sessions. The primary hypotheses are outlined below.
Detailed description
PROCEDURES
Recruitment Participants are recruited from the general population of individuals self-identifying as having symptoms of depression and/or anxiety in each study site (Ottawa, Denver, Victoria). Study advertisements are posted and circulated through post-secondary institutions, online, and within psychotherapy treatment centres. Participants experiencing depression and/or anxiety are invited to contact the research coordinator of the project via the email listed on recruitment material. All interested participants receive a telephone screen by research research assistants to assess potential eligibility. Participants who are deemed potentially eligible are informed that they will be contacted by an assessor to be invited for an initial study assessment session to determine final eligibility.
Baseline assessment Assessors are individuals with clinical experience in psychotherapy or counselling at each of the study sites. Informed consent is reviewed and participants have the opportunity to have all their questions and concerns addressed. Assessors administer the diagnostic criteria modules of the ADIS-5 during this session. Assessments take place either within the private practice locations at each study site or the university offices of the investigators in a research session lasting approximately 1-2 hours. During the pandemic while it is not safe to meet in person, secure encrypted video call platforms are used to hold these sessions. Responses are evaluated by the assessors' supervisors, at which point final eligibility is determined. The assessments and therapy take place either within the private practice locations at each study site as specified or the university offices of the co-investigators, or online using a secure encrypted video call platform when it is unsafe to meet for in-person sessions due to the pandemic. After completion of the baseline assessment session, eligible participants are given access to an online questionnaire to complete at their own convenience. After completion of the questionnaire, participants are randomly assigned to study condition.
Random assignment Once participants have been deemed eligible to take part, and have completed the baseline questionnaire, they are randomly assigned to the EFIT (treatment) condition or the waitlist plus online CBT (control group) condition by the research co-ordinator. A list of numbers (i.e., 1-40 for Ottawa, 1-28 for Victoria, and 1-20 for Denver) are generated for each city, reflecting the total number of EFIT and control clients for that city. Within those groups, a separate randomized list (i.e., 20 total numerical values for Ottawa, 14 for Victoria, and 10 for Denver) is generated using Research Randomizer, an online tool for random assignment that has been used in previous RCT studies. As participants are deemed eligible, they are added onto the list and their number will determine whether they will take part in either the EFIT intervention or the control group.
Interventions:
EFIT Treatment Group Twenty-two experienced EFT therapists trained in the EFIT model will provide 15 sessions of EFIT treatment to approximately 2 clients each. Therapy will be carried out in private practices or the university offices of researchers located in each of the study sites, or online using a secure encrypted video call platform when not possible to meet in person due to the pandemic. Each site is associated with an EFT centre: Ottawa Institute of Couple and Family Therapy in Ottawa, Centre for EFT Vancouver Island in Victoria, and Colorado Centre for EFT in Denver. Study therapists will receive an average of 1 hour of supervision per week in groups of 3-4 therapists. Each therapy session will be video recorded and treatment fidelity will be confirmed through the coding of video tapes. After each therapy session, therapists will ask participants to complete a brief online questionnaire that takes approximately 10 minutes to complete. The link to the online questionnaire will be sent to each therapist by the research co-ordinator.
Wait-List plus online CBT Control Group Participants randomly assigned to the wait-list control group will wait 15 weeks, following which time they will be given an online transdiagnostic cognitive-behavioural treatment (MoodGym) for depression and anxiety that has been empirically validated after they have completed the 15-week wait period. They will be given access to complete 15 weeks of the online intervention. These participants will also be requested to complete a brief online questionnaire on a weekly basis - this questionnaire is identical to the questionnaire given to EFIT participants after each therapy session with the exception that it does not include the Working Alliance Inventory (WAI) or the Post-session Resolution Questionnaire (PSRQ) as these questionnaires are only relevant to therapy sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a randomized controlled trial (RCT) carried out across three study sites (Ottawa, Denver, Victoria). We will have two study groups, treatment (n=44) and wait-list control (n=44). The wait-list control will be given an online transdiagnostic cognitive-behavioural treatment for depression and anxiety that has been empirically validated. The treatment condition group will be provided 12-15 sessions of Emotionally Focused Therapy for Individuals. Approximately 22 experienced EFT therapists will be given training in EFIT and will provide treatment to 2-3 clients each. Therapy will be carried out in person and/or online.
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control Group (CBT) | Active comparator | Behavioral: Self-Help CBT TrainingIndividuals in this arm (n=44) are provided with a transdiagnostic cognitive-behavioural treatment for depression and anxiety (MoodGym) that has been empirically validated after their 15-week wait period is complete. |
| EFIT Group | Experimental | Behavioral: Emotionally Focused Therapy for IndividualsIndividuals in the EFIT Group (n=44) will receive 12-15 sessions of EFIT in order to treat their symptoms of depression and anxiety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of Major Depressive Disorder with co-morbid symptoms of anxiety
- Inclusion cut offs: Participants must score in the mild-to severe range on BDI-II and mild-moderate on the BAI
- At least 18 years old
Key exclusion criteria (2 listed)
- Psychotropic medication change in 6 weeks prior to enrollment or anticipated during the study period (this allows us to include people who are taking a medication but mitigates the risk of medication changes as a problematic factor; assessed in phone screen)
- Current DSM diagnosis of bipolar disorder, schizophrenia-spectrum disorder, PTSD, eating disorder, personality disorder, or substance abuse or dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotionally Focused Therapy for IndividualsEmotionally Focused Therapy for Individuals (EFIT) is formulated as a transdiagnostic treatment to treat depression and anxiety, adapted from the well-studied Emotionally Focused Therapy. EFIT has been formulated as an attachment-based alternative to current cognitive approaches (e.g., Cognitive Behavioural Therapy). The strong evidence for insecure attachment as an underlying factor in psychopathology, especially depression and anxiety, positions this theory well as a foundational principle to support psychotherapy for these conditions. | Behavioural | EFIT Group |
| Self-Help CBT TrainingAlso: MoodGymIndividuals in the Waitlist Control Group will receive access to MoodGym, a self-help online program that helps teach CBT interventions. This access will last 15 weeks and is self-driven, meaning participants proceed through the program at their own pace. | Behavioural | Waitlist Control Group (CBT) |
Primary outcome
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)
Time frame: Change from baseline to completion of the 15 week intervention.
The ADIS-5 is a structured interview intended to help clinicians diagnose psychological disorders based on DSM-5 criteria. The ADIS-5 also allows for differential diagnosis and has been widely used in clinical research. Assessors will administer the ADIS-5 and determine whether or not the participants the criteria for a diagnosis of anxiety and/or depression, and to assess change upon completion of the 15-week intervention.
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)
Time frame: Change from baseline to completion of the 15 week wait period.
The ADIS-5 is a structured interview intended to help clinicians diagnose psychological disorders based on DSM-5 criteria. The ADIS-5 also allows for differential diagnosis and has been widely used in clinical research. Assessors will administer the ADIS-5 and determine whether or not the participants the criteria for a diagnosis of anxiety and/or depression, and to assess change at post 15-week wait period.
Beck Depression Inventory-2 (BDI-2)
Time frame: Change from baseline to week 5, week 7, completion of 15-week wait period (control condition), and 3, 6, 9 and 12 months following completion of the wait-period.
The Beck Depression Inventory-2 is a 21-item self-report questionnaire used to assess the severity of depressive symptoms (e.g., sadness, guilt, crying, suicidal thoughts, etc.). Participants are presented with a list of themes and are asked to choose a statement that best fits their mood over the past two weeks. Each statement has a corresponding numerical value. The sum all statements are calculated for scoring purposes. A score of 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and a score above 29 indicates severe depression. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI after session 5 and 7.
Beck Depression Inventory-2 (BDI-2)
Time frame: Change from baseline to week 5, week 7, completion of 15-week intervention, and 3, 6, 9 and 12 months following the intervention.
The Beck Depression Inventory-2 is a 21-item self-report questionnaire used to assess the severity of depressive symptoms (e.g., sadness, guilt, crying, suicidal thoughts, etc.). Participants are presented with a list of themes and are asked to choose a statement that best fits their mood over the past two weeks. Each statement has a corresponding numerical value. The sum all statements are calculated for scoring purposes. A score of 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and a score above 29 indicates severe depression. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI after session 5 and 7.
Beck Anxiety Inventory (BAI)
Time frame: Change from baseline to week 5, week 7, and completion of 15-week wait period (control condition) and at 3, 6, 9, and 12 months after completing the wait-period
The Beck Anxiety Inventory is a 21-item self-report questionnaire used to assess common symptoms of anxiety (e.g., rapid heartbeat, sweating, numbness, trembling, etc.). Participants are presented with a list of common symptoms of anxiety and are asked to note how much they experienced each over the past week from a four item Likert scale ("not at all", "mildly", "moderately", and "severely"). The total score is calculated by finding the sum of all 21 items; a score of 0-21 indicated low anxiety, 22-35 indicates moderate anxiety, and a score of 36 and above indicates potentially concerning levels of anxiety. Both of the Beck inventories used in this study have been widely used in clinical research and possess good reliability and validity. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI-2 after session 5 and 7.
Beck Anxiety Inventory (BAI)
Time frame: Change from baseline to week 5, week 7 and completion of 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
The Beck Anxiety Inventory is a 21-item self-report questionnaire used to assess common symptoms of anxiety (e.g., rapid heartbeat, sweating, numbness, trembling, etc.). Participants are presented with a list of common symptoms of anxiety and are asked to note how much they experienced each over the past week from a four item Likert scale ("not at all", "mildly", "moderately", and "severely"). The total score is calculated by finding the sum of all 21 items; a score of 0-21 indicated low anxiety, 22-35 indicates moderate anxiety, and a score of 36 and above indicates potentially concerning levels of anxiety. Both of the Beck inventories used in this study have been widely used in clinical research and possess good reliability and validity. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI-2 after session 5 and 7.
Outcome Questionnaire-30.2
Time frame: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
The Outcome Questionnaire-30.2 is a brief 30-item instrument intended to measure client progress before, during, and following clinical interventions. This questionnaire is was adapted from the OQ-45, is highly sensitive to session-by-session changes, and possesses high levels of reliability and validity. Over the course of the study, this questionnaire will be repeatedly administered in order to monitor participants' progress through the EFIT and waitlist conditions. This questionnaire will also be administered during the 4 follow-up time points.
Outcome Questionnaire-30.2
Time frame: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
The Outcome Questionnaire-30.2 is a brief 30-item instrument intended to measure client progress before, during, and following clinical interventions. This questionnaire is was adapted from the OQ-45, is highly sensitive to session-by-session changes, and possesses high levels of reliability and validity. Over the course of the study, this questionnaire will be repeatedly administered in order to monitor participants' progress through the EFIT and waitlist conditions. This questionnaire will also be administered during the 4 follow-up time points.
Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)
Time frame: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
The Patient-Reported Outcomes Measurement Information System-Anxiety scale is an 8-item tool designed to measure participants' self-reported anxiety symptoms over the past week. Participants are asked to respond to eight anxiety-related statements on a 5-point Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always).
Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)
Time frame: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
The Patient-Reported Outcomes Measurement Information System-Anxiety scale is an 8-item tool designed to measure participants' self-reported anxiety symptoms over the past week. Participants are asked to respond to eight anxiety-related statements on a 5-point Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always).
Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)
Time frame: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
The Patient-Reported Outcomes Measurement Information System-Depression scale is an 8-item scale used to measure participants' self-reported depression symptoms over the past week. Participants are asked to respond to eight depression-related statements on the same 5-point Likert scale as the PROMIS-Anxiety measure.
Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)
Time frame: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
The Patient-Reported Outcomes Measurement Information System-Depression scale is an 8-item scale used to measure participants' self-reported depression symptoms over the past week. Participants are asked to respond to eight depression-related statements on the same 5-point Likert scale as the PROMIS-Anxiety measure.
22 secondary outcomes
Childhood Trauma Questionnaire-Short Form
Time frame: Baseline
Trauma Symptom Inventory-2
Time frame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Trauma Symptom Inventory-2
Time frame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Experiences in Close Relationships Questionnaire (ECR)
Time frame: Change from baseline, to across each weekly treatment session for 15 weeks, to after completion of the 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
Experiences in Close Relationships Questionnaire (ECR)
Time frame: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
Reflective Function Questionnaire-8 (RFQ)
Time frame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Reflective Function Questionnaire-8 (RFQ)
Time frame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Inventory of Interpersonal Problems-32
Time frame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Inventory of Interpersonal Problems-32
Time frame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Difficulties in Emotion Regulation Scale
Time frame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Difficulties in Emotion Regulation Scale
Time frame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Leuven Affect and Pleasure Scale
Time frame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Leuven Affect and Pleasure Scale
Time frame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Rosenberg Self-Esteem Scale
Time frame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Rosenberg Self-Esteem Scale
Time frame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Patient-Reported Outcomes Measurement Information System-Meaning (PROMIS Meaning)
Time frame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Patient-Reported Outcomes Measurement Information System-Meaning (PROMIS Meaning)
Time frame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Multi-dimensional Assessment of Interoceptive Awareness
Time frame: Change from baseline to week 5 and week 7, and completion of 15-week wait period (control condition) and across to 3, 6, 9, and 12 month follow-up time points
Multi-dimensional Assessment of Interoceptive Awareness
Time frame: Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points
Post Session Resolution Questionnaire (PSQR)
Time frame: Weekly for 15 weeks of the experimental condition
Working Alliance Inventory
Time frame: Weekly for 15 weeks of the experimental condition
Sociodemographic Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 28768327Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
- Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- Background: PubMed 29117870Demyttenaere K, Mortier P, Kiekens G, Bruffaerts R. Is there enough "interest in and pleasure in" the concept of depression? The development of the Leuven Affect and Pleasure Scale (LAPS). CNS Spectr. 2019 Apr;24(2):265-274. doi: 10.1017/S1092852917000578. Epub 2017 Nov 9.
- Background: PubMed 27392018Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
- Background: PubMed 3204198Horowitz LM, Rosenberg SE, Baer BA, Ureno G, Villasenor VS. Inventory of interpersonal problems: psychometric properties and clinical applications. J Consult Clin Psychol. 1988 Dec;56(6):885-92. doi: 10.1037//0022-006x.56.6.885. No abstract available.
- Background: PubMed 23133619Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
- Background: PubMed 9881538Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Derived from this study: PubMed 40638305Wiebe SA, Johnson SM, Allan R, Campbell TL, Greenman PS, Fairweather DR, Ismail M, Tasca GA. A randomized controlled trial of emotionally focused individual therapy (EFIT) for depression and anxiety. Psychotherapy (Chic). 2025 Sep;62(3):414-423. doi: 10.1037/pst0000586. Epub 2025 Jul 10.
- Applied longitudinal data analysis: Modeling change and event occurrenceLink provided by the sponsor.
- Attachment Theory in Practice: Emotionally Focused Therapy with Individuals, Couples and FamiliesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Wiebe, PhD principal investigator
Saint Paul University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotionally Focused Therapy for Individuals and Self-Help CBT Training in people with Depression, Anxiety, run by Saint Paul University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) (time frame: Change from baseline to completion of the 15 week intervention.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719780, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.