Emotional DisordersNCT02578758
Efficacy of a Transdiagnostic Internet-based Protocol in Community Sample
A study testing Transdiagnostic internet-based protocol and Transdiagnostic internet-based protocol + positive affect component in people with Emotional Disorders and Anxiety, run by Universitat Jaume I at 1 site in Spain.
Trial summary
The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol (Emotion Regulation Protocol) for the treatment of Emotional Disorders (ED) (major depression disorder, dysthymic disorder, obsessive-compulsive disorder and four anxiety disorders: panic disorder, agoraphobia, generalized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Disorders, Anxiety, Depression
- What is being tested?
- Transdiagnostic internet-based protocol and Transdiagnostic internet-based protocol + positive affect component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Jun 2020
- 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
- Be 18 years old or older.
- Meeting the DSM-IV diagnosis criteria of emotional disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, major depression disorder and dysthymia).
- Providing written, informed consent.
- Being able to understand and read Spanish.
- Having daily access to the Internet in their natural environment.
Who cannot join
- Being diagnosed a severe mental disorder (people with the following mental disorders will be excluded from the study: schizophrenia, bipolar disorder and personality disorders from clusters A and B).
- Being diagnosed an alcohol and/or substance dependence disorder.
- The presence of high suicidal risk.
- A medical disease or condition which prevent the participant from carry out the psychological treatment.
- Receiving another psychological treatment while the study is still ongoing.
- The increase and/or changes in the medication of participants receiving pharmacological treatment during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Differential Efficacy of a Specific Positive Psychology Components in a Transdiagnostic Internet-based Protocol for the Treatment of Emotional Disorders
The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol (Emotion Regulation Protocol) for the treatment of Emotional Disorders (ED) (major depression disorder, dysthymic disorder, obsessive-compulsive disorder and four anxiety disorders: panic disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) both in terms of efficacy regarding depressive and anxiety symptomatology and its potential impact on higher-order psychological dimensions (neuroticism/behavioral inhibition and low positive affect/behavioral activation) in a community sample. It will also be tested the differential effect of a specific treatment component based on positive psychology techniques in positive affect. The main hypotheses are: 1) both modalities of the protocol (TP and TP+PA) will be more effective than the WL condition in the primary outcome measures. Investigators also expect scores on positive affect to be higher in the TP+PA condition than in the TP condition.
Read the detailed description
Emotional disorders (ED) (anxiety and mood disorders) are among the most prevalent mental disorders, with a life prevalence of 29% and comorbidity rates that range between 40 and 80%. If they are not adequately treated the course is often chronic, and significantly affect important functioning areas such as work and social relationships. Thus, these data strongly suggest efficacious and efficient treatments are needed in order to address this important health problem. The classification and differentiation of mental disorders carried out in manuals like the Diagnositc and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases (ICD) has played an important role in the emphasis placed on the research about the treatment of specific disorders; however, it has also been a problem in the dissemination of evidenced-based treatments due to the difficulties in training the clinicians in the variety of the available disorder-specific programs. In the other hand, Evidence-based psychological treatments (EBPT) have shown efficacy in the treatment of ED, however, less than 50 % of people with ED receive treatment and causes include costs, time of application and the lack of well-trained professionals. In addition, epidemiological studies have shown that at least 55% of people suffering from an anxiety disorder suffer from another anxiety disorder at the moment of the assessment, and this prevalence rate is up to 76% when different lifespan diagnoses are taken into account. This high comorbidity rate indicates that the different ED share important characteristics and it has been proposed that this overlapping is accounted for by common biological and psychological vulnerabilities that along with psychosocial stress factors leads to different manifestations of the same vulnerability, i. e., the different mood and anxiety disorders. Thus, a Transdiagnostic approach could help overcome these barriers.
Transdiagnostic approaches have implications in the treatment of psychological disorders as a number of treatment protocols have been developed based on this perspective. Clark has distinguished three perspectives in transdiagnostic cognitive-behavioral therapy: a) The transdiagnostic practice, a pragmatic perspective that includes components of various disorder-specific intervention protocols whose aim is to determine which are the active components in samples with those disorders. The contributions of Norton, Andrews and Titov, and the study: Coordinated Anxiety Learning and Management (CALM) belong to this category. b) The transdiagnostic theory, that specifies a theoretical framework which outlines the common psychological constructs that influence the maintenance of ED. For instance, the tripartite model of anxiety and depression, with positive and negative affect as relevant constructs. c) The Unified Protocol. The Barlow's team has designed a protocol, adequate for the treatment of ED which focuses on four essential aspects: to increase present-focused emotional awareness, to identify and modify emotional avoidance patterns, to promote the cognitive flexibility and to facilitate exposure to avoided situations and sensations.
Another aspect that could enhance the dissemination of evidence-based treatments as well as considerably reduce the costs is the use of the Internet. A number of systematic reviews has shown that Internet-based treatments yield similar results when compared to face-to-face therapy. Nevertheless, most of these programs are focused on a single disorder since very few transdiagostic internet-based treatments have been developed and tested by means of randomized controlled trials so far.
The main objective of the treatment components of the Unified Protocol (UP) is to train patients in the regulation of negative emotions or negative affect (NA), but less attention has been paid to the inclusion of treatment components directly targeting positive affect (PA) regulation.
Investigators of this research group (LabPsiTec) have developed a traditional transdiagnostic treatment that is partly based on the UP and it has been added a specific component of positive affect regulation in order to more directly target the regulation of positive affect. The study will include three conditions: 1) Transdiagnostic protocol (TP); 2) Transdiagnostic protocol + positive affect component (TP+PA); and 3) Waiting list control group (WL).
The main hypothesis is that both modalities of the protocol (TP and TP+PA) will result more effective than the WL condition in the primary outcome measures. Investigators expect scores on positive affect to be higher in the TP+PA condition than in the TP condition.
- Conditions
- Emotional Disorders, Anxiety, Depression
- Being tested
- Transdiagnostic internet-based protocol, Transdiagnostic internet-based protocol + positive affect component, Waiting List Control Group
- Keywords
- Transdiagnostic Internet-based Protocol, Positive affect regulation
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic internet-based protocolBehavioural
Transdiagnostic internet-based protocol is an Internet-based Protocol for ED, which will allow the individual to learn and practice adaptive ways to regulate their emotions from a transdiagnostic perspective. The protocol contains the following components: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention, which are organized in 12 modules: Emotional disorders and emotion regulation; Motivation for change; Understanding the role of emotions; The acceptance of emotional experiences; Practicing the acceptance; Learning to be flexible; Practicing the cognitive flexibility; The emotional avoidance; Emotion driven behaviors; Accepting and facing physical sensations; Facing emotions in the contexts in which they occur; and Relapse Prevention.
Transdiagnostic internet-based protocol + positive affect componentBehavioural
Transdiagnostic internet-based protocol + positive affect component is an Internet-based protocol for ED. This protocol contains several transdiagnostic components (present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention) and a specific positive affect regulation component. These components are organized in 16 treatment modules: Emotional disorders and emotion regulation; Motivation for change; Understanding the role of emotions; The acceptance of emotional experiences; Practicing the acceptance; Learning to be flexible; Practicing the cognitive flexibility; The emotional avoidance; Emotion driven behaviors; Accepting and facing physical sensations; Facing emotions in the contexts in which they occur; Learning to move on; Learning to enjoy; Learning to live; Living and learning; and Relapse Prevention.
Waiting List Control GroupOther
Participants in a 18-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the wating list period.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic Internet-Based Protocol | Experimental | Intervention group that carries out the Transdiagnostic Internet-Based Protocol and receives support by the therapist (a brief weekly two-minute phone call without clinical content and two weekly orientative text messages). Receives: Behavioral: Transdiagnostic internet-based protocol |
| Transdiagnostic Internet-Based Protocol+Positive Affect | Experimental | Intervention group that carries out the Transdiagnostic Internet-Based Protocol+Positive Affect component and receives support by the therapist (a brief weekly two-minute phone call without clinical content and two weekly orientative text messages). Receives: Behavioral: Transdiagnostic internet-based protocol + positive affect component |
| Waiting List Control Group | Other | Participants in a 18-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the waiting list period. Receives: Other: Waiting List Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) at pre, post intervention and at 3 and 12 months follow-ups.
The BDI-II is one of the most widely used questionnaires to evaluate the severity of depression in pharmacological and psychotherapy trials. It consists of 21 items about the different symptoms characterizing the major depression disorder, summed to obtain the total score, which can be a maximum of 63 points. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and a test-retest reliability of around 0.8.
Measured: Up to 12 months
Change in the Beck Anxiety Inventory (BAI) (Beck, & Steer, 1990) at pre, post intervention and at 3 and 12 months follow-ups.
The BAI is a 21-item self-report measure designed to assess anxiety. Each item has a 4-point Severity scale (e.g., not at all, mildly, moderately, and severely) that addresses symptoms experienced during the past week. The internal consistency of the BAI has been found to range from .85 to .94 and has been found to have adequate convergent and divergent validity.
Measured: Up to 12 months
Secondary outcomes (5)
Change in the Obsessive-Compulsive Inventory (OCI-R) (Foa et al., 2002) at pre, post intervention and at 3 and 12 months follow-ups.
The OCI-R is a scale made up of 18 items rated 1 to 4 and organized in 6 dimensions (washing, verification, order, obsession, hoarding and mental neutralization) that assesses obsessive-compulsive behaviors. The OCI-R has a good internal consistency (coefficient alpha between .81 and .93), a good to excellent test-retest reliability (between .57 and .91), a good convergent validity and a solid factor structure.
Measured: Up to 12 months
Change in the Self-Reported Panic Disorder Severity Scale (PDSS-SR) (Houck, Spiegel, Shear, & Rucci, 2002) at pre, post intervention and at 3 and 12 months follow-ups.
The scale measures the severity of the panic disorder through measures of panic attack frequency, distress during the panic attacks, anticipatory anxiety, fear and agoraphobic avoidance, fear and avoidance of physical sensations, and work and social impairment. The reliability of the scale has proved to be excellent (coefficient alpha of .917) as also has done the test-retest reliability (ICC = .81).
Measured: Up to 12 months
Change in the Pen State Worry Questionnaire (PSWQ) (Meyer, Miller, Metzger, & Borkovec, 1990) at pre, post intervention and at 3 and 12 months follow-ups.
It is a questionnaire that evaluates the worry as an incontrollable, generalized and excessive experience. The psychometric properties of the PSWQ have proved to be good, with an internal consistency ranging from .91 to .95, and a good validity and test-retest reliability.
Measured: Up to 12 months
Change in the Social Interaction Anxiety Inventory (SIAS) (Mattick y Clarke, 1998) at pre, post intervention and at 3 and 12 months follow-ups.
This scale is made up of twenty items rated 0 to 4 that asses the anxiety experienced by the patient in social interactive situations. The scale has a good internal consistency (alpha coefficient between .88 and .94), good test-retest and discriminant reliability, as well as appropriate construct validity.
Measured: Up to 12 months
The Positive and Negative Affect Schedule (PANAS) (Watson, Clark y Tellengen, 1988; Sandín et al., 1999) at pre, post intervention and at 3 and 12 months follow-ups.
The PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is from 10 to 50. The Spanish version has demonstrated high internal consistency (α = 0.89 and 0.91 for PA and NA in women, respectively, and α = 0.87 and 0.89 for PA and NA in men, respectively) in college students.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Emotional DisordersStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Sponsor
- Investigators
- Cristina Botella, Professor, Study director, Universitat Jaume I, Castellon, SpainAmanda Díaz, PhD Student, Study chair, Universitat Jaume I, Castellon, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578758
- Sponsor's protocol ID
- UJAUMEI014
- Status last verified
- Jun 2022
- First submitted
- 15 Oct 2015
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Titov N, Andrews G, Johnston L, Robinson E, Spence J. Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial. Behav Res Ther. 2010 Sep;48(9):890-9. doi: 10.1016/j.brat.2010.05.014. Epub 2010 May 24.
PubMed 20561606Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P. Transdiagnostic internet treatment for anxiety and depression: a randomised controlled trial. Behav Res Ther. 2011 Aug;49(8):441-52. doi: 10.1016/j.brat.2011.03.007. Epub 2011 Apr 3.
PubMed 21679925Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.
PubMed 22697453Carl JR, Soskin DP, Kerns C, Barlow DH. Positive emotion regulation in emotional disorders: a theoretical review. Clin Psychol Rev. 2013 Apr;33(3):343-60. doi: 10.1016/j.cpr.2013.01.003. Epub 2013 Jan 12.
PubMed 23399829Diaz-Garcia A, Gonzalez-Robles A, Garcia-Palacios A, Fernandez-Alvarez J, Castilla D, Breton JM, Banos RM, Quero S, Botella C. Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Feb 1;23(2):e21335. doi: 10.2196/21335.
PubMed 33522977Diaz-Garcia A, Gonzalez-Robles A, Fernandez-Alvarez J, Garcia-Palacios A, Banos RM, Botella C. Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial. BMC Psychiatry. 2017 Apr 20;17(1):145. doi: 10.1186/s12888-017-1297-z.
PubMed 28424068
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Efficacy of a Specific Positive Psychology Components in a Transdiagnostic Internet-based Protocol for the Treatment of Emotional Disorders
- ClinicalTrials.gov ID
- NCT02578758
- Acronym / sponsor ID
- UJAUMEI014
- Conditions
- Emotional Disorders, Anxiety, Depression
- Keywords
- Transdiagnostic Internet-based Protocol, Positive affect regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- Sep 2014
- Primary completion
- Nov 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 19 Oct 2015 (estimated)
- 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 aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol (Emotion Regulation Protocol) for the treatment of Emotional Disorders (ED) (major depression disorder, dysthymic disorder, obsessive-compulsive disorder and four anxiety disorders: panic disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) both in terms of efficacy regarding depressive and anxiety symptomatology and its potential impact on higher-order psychological dimensions (neuroticism/behavioral inhibition and low positive affect/behavioral activation) in a community sample. It will also be tested the differential effect of a specific treatment component based on positive psychology techniques in positive affect. The main hypotheses are: 1) both modalities of the protocol (TP and TP+PA) will be more effective than the WL condition in the primary outcome measures. Investigators also expect scores on positive affect to be higher in the TP+PA condition than in the TP condition.
Detailed description
Emotional disorders (ED) (anxiety and mood disorders) are among the most prevalent mental disorders, with a life prevalence of 29% and comorbidity rates that range between 40 and 80%. If they are not adequately treated the course is often chronic, and significantly affect important functioning areas such as work and social relationships. Thus, these data strongly suggest efficacious and efficient treatments are needed in order to address this important health problem. The classification and differentiation of mental disorders carried out in manuals like the Diagnositc and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases (ICD) has played an important role in the emphasis placed on the research about the treatment of specific disorders; however, it has also been a problem in the dissemination of evidenced-based treatments due to the difficulties in training the clinicians in the variety of the available disorder-specific programs. In the other hand, Evidence-based psychological treatments (EBPT) have shown efficacy in the treatment of ED, however, less than 50 % of people with ED receive treatment and causes include costs, time of application and the lack of well-trained professionals. In addition, epidemiological studies have shown that at least 55% of people suffering from an anxiety disorder suffer from another anxiety disorder at the moment of the assessment, and this prevalence rate is up to 76% when different lifespan diagnoses are taken into account. This high comorbidity rate indicates that the different ED share important characteristics and it has been proposed that this overlapping is accounted for by common biological and psychological vulnerabilities that along with psychosocial stress factors leads to different manifestations of the same vulnerability, i. e., the different mood and anxiety disorders. Thus, a Transdiagnostic approach could help overcome these barriers.
Transdiagnostic approaches have implications in the treatment of psychological disorders as a number of treatment protocols have been developed based on this perspective. Clark has distinguished three perspectives in transdiagnostic cognitive-behavioral therapy: a) The transdiagnostic practice, a pragmatic perspective that includes components of various disorder-specific intervention protocols whose aim is to determine which are the active components in samples with those disorders. The contributions of Norton, Andrews and Titov, and the study: Coordinated Anxiety Learning and Management (CALM) belong to this category. b) The transdiagnostic theory, that specifies a theoretical framework which outlines the common psychological constructs that influence the maintenance of ED. For instance, the tripartite model of anxiety and depression, with positive and negative affect as relevant constructs. c) The Unified Protocol. The Barlow's team has designed a protocol, adequate for the treatment of ED which focuses on four essential aspects: to increase present-focused emotional awareness, to identify and modify emotional avoidance patterns, to promote the cognitive flexibility and to facilitate exposure to avoided situations and sensations.
Another aspect that could enhance the dissemination of evidence-based treatments as well as considerably reduce the costs is the use of the Internet. A number of systematic reviews has shown that Internet-based treatments yield similar results when compared to face-to-face therapy. Nevertheless, most of these programs are focused on a single disorder since very few transdiagostic internet-based treatments have been developed and tested by means of randomized controlled trials so far.
The main objective of the treatment components of the Unified Protocol (UP) is to train patients in the regulation of negative emotions or negative affect (NA), but less attention has been paid to the inclusion of treatment components directly targeting positive affect (PA) regulation.
Investigators of this research group (LabPsiTec) have developed a traditional transdiagnostic treatment that is partly based on the UP and it has been added a specific component of positive affect regulation in order to more directly target the regulation of positive affect. The study will include three conditions: 1) Transdiagnostic protocol (TP); 2) Transdiagnostic protocol + positive affect component (TP+PA); and 3) Waiting list control group (WL).
The main hypothesis is that both modalities of the protocol (TP and TP+PA) will result more effective than the WL condition in the primary outcome measures. Investigators expect scores on positive affect to be higher in the TP+PA condition than in the TP condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Internet-Based Protocol | Experimental | Behavioral: Transdiagnostic internet-based protocolIntervention group that carries out the Transdiagnostic Internet-Based Protocol and receives support by the therapist (a brief weekly two-minute phone call without clinical content and two weekly orientative text messages). |
| Transdiagnostic Internet-Based Protocol+Positive Affect | Experimental | Behavioral: Transdiagnostic internet-based protocol + positive affect componentIntervention group that carries out the Transdiagnostic Internet-Based Protocol+Positive Affect component and receives support by the therapist (a brief weekly two-minute phone call without clinical content and two weekly orientative text messages). |
| Waiting List Control Group | Other | Other: Waiting List Control GroupParticipants in a 18-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the waiting list period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years old or older.
- Meeting the DSM-IV diagnosis criteria of emotional disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, major depression disorder and dysthymia).
- Providing written, informed consent.
- Being able to understand and read Spanish.
- Having daily access to the Internet in their natural environment.
Key exclusion criteria (6 listed)
- Being diagnosed a severe mental disorder (people with the following mental disorders will be excluded from the study: schizophrenia, bipolar disorder and personality disorders from clusters A and B).
- Being diagnosed an alcohol and/or substance dependence disorder.
- The presence of high suicidal risk.
- A medical disease or condition which prevent the participant from carry out the psychological treatment.
- Receiving another psychological treatment while the study is still ongoing.
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 |
|---|---|---|
| Transdiagnostic internet-based protocolTransdiagnostic internet-based protocol is an Internet-based Protocol for ED, which will allow the individual to learn and practice adaptive ways to regulate their emotions from a transdiagnostic perspective. The protocol contains the following components: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention, which are organized in 12 modules: Emotional disorders and emotion regulation; Motivation for change; Understanding the role of emotions; The acceptance of emotional experiences; Practicing the acceptance; Learning to be flexible; Practicing the cognitive flexibility; The emotional avoidance; Emotion driven behaviors; Accepting and facing physical sensations; Facing emotions in the contexts in which they occur; and Relapse Prevention. | Behavioural | Transdiagnostic Internet-Based Protocol |
| Transdiagnostic internet-based protocol + positive affect componentTransdiagnostic internet-based protocol + positive affect component is an Internet-based protocol for ED. This protocol contains several transdiagnostic components (present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention) and a specific positive affect regulation component. These components are organized in 16 treatment modules: Emotional disorders and emotion regulation; Motivation for change; Understanding the role of emotions; The acceptance of emotional experiences; Practicing the acceptance; Learning to be flexible; Practicing the cognitive flexibility; The emotional avoidance; Emotion driven behaviors; Accepting and facing physical sensations; Facing emotions in the contexts in which they occur; Learning to move on; Learning to enjoy; Learning to live; Living and learning; and Relapse Prevention. | Behavioural | Transdiagnostic Internet-Based Protocol+Positive Affect |
| Waiting List Control GroupParticipants in a 18-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the wating list period. | Other | Waiting List Control Group |
Primary outcome
Change in the Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) at pre, post intervention and at 3 and 12 months follow-ups.
Time frame: Up to 12 months
The BDI-II is one of the most widely used questionnaires to evaluate the severity of depression in pharmacological and psychotherapy trials. It consists of 21 items about the different symptoms characterizing the major depression disorder, summed to obtain the total score, which can be a maximum of 63 points. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and a test-retest reliability of around 0.8.
Change in the Beck Anxiety Inventory (BAI) (Beck, & Steer, 1990) at pre, post intervention and at 3 and 12 months follow-ups.
Time frame: Up to 12 months
The BAI is a 21-item self-report measure designed to assess anxiety. Each item has a 4-point Severity scale (e.g., not at all, mildly, moderately, and severely) that addresses symptoms experienced during the past week. The internal consistency of the BAI has been found to range from .85 to .94 and has been found to have adequate convergent and divergent validity.
5 secondary outcomes
Change in the Obsessive-Compulsive Inventory (OCI-R) (Foa et al., 2002) at pre, post intervention and at 3 and 12 months follow-ups.
Time frame: Up to 12 months
Change in the Self-Reported Panic Disorder Severity Scale (PDSS-SR) (Houck, Spiegel, Shear, & Rucci, 2002) at pre, post intervention and at 3 and 12 months follow-ups.
Time frame: Up to 12 months
Change in the Pen State Worry Questionnaire (PSWQ) (Meyer, Miller, Metzger, & Borkovec, 1990) at pre, post intervention and at 3 and 12 months follow-ups.
Time frame: Up to 12 months
Change in the Social Interaction Anxiety Inventory (SIAS) (Mattick y Clarke, 1998) at pre, post intervention and at 3 and 12 months follow-ups.
Time frame: Up to 12 months
The Positive and Negative Affect Schedule (PANAS) (Watson, Clark y Tellengen, 1988; Sandín et al., 1999) at pre, post intervention and at 3 and 12 months follow-ups.
Time frame: Up to 12 months
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 16 Jun 2022.
- Background: PubMed 20561606Titov N, Andrews G, Johnston L, Robinson E, Spence J. Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial. Behav Res Ther. 2010 Sep;48(9):890-9. doi: 10.1016/j.brat.2010.05.014. Epub 2010 May 24.
- Background: PubMed 21679925Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P. Transdiagnostic internet treatment for anxiety and depression: a randomised controlled trial. Behav Res Ther. 2011 Aug;49(8):441-52. doi: 10.1016/j.brat.2011.03.007. Epub 2011 Apr 3.
- Background: PubMed 22697453Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.
- Background: PubMed 23399829Carl JR, Soskin DP, Kerns C, Barlow DH. Positive emotion regulation in emotional disorders: a theoretical review. Clin Psychol Rev. 2013 Apr;33(3):343-60. doi: 10.1016/j.cpr.2013.01.003. Epub 2013 Jan 12.
- Derived from this study: PubMed 33522977Diaz-Garcia A, Gonzalez-Robles A, Garcia-Palacios A, Fernandez-Alvarez J, Castilla D, Breton JM, Banos RM, Quero S, Botella C. Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Feb 1;23(2):e21335. doi: 10.2196/21335.
- Derived from this study: PubMed 28424068Diaz-Garcia A, Gonzalez-Robles A, Fernandez-Alvarez J, Garcia-Palacios A, Banos RM, Botella C. Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial. BMC Psychiatry. 2017 Apr 20;17(1):145. doi: 10.1186/s12888-017-1297-z.
- Laboratory of Psychology and Technology of the University Jaume ILink provided by the sponsor.
- Web site of the intervention programLink provided by the sponsor.
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Not yet recruitingObservational study
Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
Anxiety
Active, not recruiting
Improving Emotional Wellbeing of University Students: Anxiety Management
Anxiety
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.
Cristina Botella, Professor study director
Universitat Jaume I, Castellon, Spain
Amanda Díaz, PhD Student study chair
Universitat Jaume I, Castellon, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic internet-based protocol and Transdiagnostic internet-based protocol + positive affect component in people with Emotional Disorders and Anxiety, run by Universitat Jaume I at 1 site in Spain.
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 5 inclusion and 6 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 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Change in the Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) at pre, post intervention and at 3 and 12 months follow-ups. (time frame: Up to 12 months). The study lists 2 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 NCT02578758, which also lists 6 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 16 Jun 2022.