AnxietyNCT02790398
Up-regulating Positive Affect in Emotional Disorders
A study testing Transdiagnostic treatment protocol and Transdiagnostic treatment protocol + PA regulation component in people with Anxiety and Depression, run by Universitat Jaume I at 1 site in Spain.
Trial summary
The aim of this study is to assess the differential effect of two transdiagnostic treatment protocols for emotional disorders (ED) (depression and anxiety disorders) using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Transdiagnostic treatment protocol and Transdiagnostic treatment protocol + PA regulation component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Mar 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older
- meeting the DSM-IV diagnostic criteria for ED (major depression disorder, dysthimic disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, anxiety disorder not otherwise specified, unipolar mood disorder not otherwise specified)
- ability to understand and read Spanish
Who cannot join
- bipolar disorder
- schizophrenia
- risk of suicide
- receiving another psychological treatment during the study
- in the case of receiving pharmacological treatment, an increase and/or change in this treatment during the study period (a decrease in pharmacological treatment is accepted)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transdiagnostic Up-regulation of Positive Affect in Emotional Disorders: A Randomized Pilot Study
The aim of this study is to assess the differential effect of two transdiagnostic treatment protocols for emotional disorders (ED) (depression and anxiety disorders) using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol that also includes a specific component to address the regulation of positive affect (TTP+PA). Another aim was to assess the acceptability of both treatments by patients. It was hypothesized that the intervention would result in significant differences in favor of the TTP+PA protocol in all measures. Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted by the two groups of participants.
Read the detailed description
ED are highly prevalent mental disorders and one of the main causes of disability worldwide. Currently, there is evidence showing the efficacy of transdiagnostic treatments for anxiety disorders, and for comorbid depression and anxiety disorders. An important line of research within the transdiagnostic treatment of ED was initiated by D. H. Barlow. Barlow's theory of triple vulnerability emphasizes the underlying vulnerabilities that are common to ED and help to explain the comorbidity among these diverse conditions. A central aspect within this theoretical perspective is the role of emotion regulation in ED. The regulation of negative emotions in ED has received a great deal of attention in cognitive behavior therapy (CBT) research, and more recently in transdiagnostic ED models like the UP developed by Barlow's team. However, although Barlow underscored the role of low PA in the onset and maintenance of ED, the main objective of the treatment components in the UP is to train patients in negative affect (NA) regulation, but less attention has been paid to the inclusion of treatment components to directly target PA regulation. Moreover, literature has shown that higher levels of PA are associated with better physical and psychological health, healthier lifestyles, and better general functioning. Consequently, an important treatment goal from a transdiagnostic treatment approach would be to increase PA while decreasing NA.
The aim of this study is to compare the differential effect of two transdiagnostic treatment protocols for ED using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol that also includes a specific component to address the regulation of positive affect (TTP+PA). Another aim is to assess the acceptability of both treatments by patients. It was hypothesized that the intervention would result in significant differences in favor of the TTP+PA protocol in all measures. Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted by the two groups of participants.
- Conditions
- Anxiety, Depression
- Being tested
- Transdiagnostic treatment protocol, Transdiagnostic treatment protocol + PA regulation component
- Keywords
- Transdiagnostic treatment protocol, Transdiagnostic treatment protocol + PA component
- 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 treatment protocolBehavioural
Transdiagnostic treatment protocol for emotional disorders whose aims are to learn and practice adaptive ways to regulate 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. These components are organized in twelve modules.
Transdiagnostic treatment protocol + PA regulation componentBehavioural
Transdiagnostic treatment protocol for emotional disorders + PA regulation components has the purpose of learning and practicing adaptive ways to regulate emotions from a transdiagnostic perspective. This protocol includes the same components but it also includes 4 additional modules focused specifically on the regulation of positive affectivity.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic treatment protocol | Experimental | Transdiagnostic treatment protocol. Receives: Behavioral: Transdiagnostic treatment protocol |
| Transdiagnostic treatment protocol + PA regulation component | Active comparator | Transdiagnostic treatment protocol that includes a component aimed at the regulation of PA. Receives: Behavioral: Transdiagnostic treatment protocol + PA regulation component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Positive and Negative Affect Scale (PANAS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.
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 7 months
Secondary outcomes (3)
Change in the Beck Depression Inventory II (BDI-II) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.
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 7 months
Change in the Overall Anxiety Severity and Impairment Scale (OASIS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.
The OASIS consists of a 5-item questionnaire, rated from 0 to 4, that assesses the frequency and severity of the anxiety symptoms. The instrument also provides measures of avoidance, as well as work, academic, social and everyday life impairment related to anxiety symptoms. A psychometric analysis of the OASIS scale found good internal consistency (α = .80), test-retest reliability (k = .82) and convergent validity for this instrument.
Measured: Up to 7 months
Change in the Quality of Life Inventory (QLI) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.
The QLI is a brief self-report questionnaire that assesses perceived quality of life in different life-related areas. The questionnaire includes 10 items, rated on a scale from one to 10, that assess physical well-being, psychological well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, social emotional support, community and services support, personal fulfillment, spiritual fulfillment and overall quality of life. The QLI has shown excellent internal consistency (between .90 and .92), test-retest reliability (.87) and discriminant validity. The Spanish validation of the QLI has also demonstrated good test-retest reliability (α = .89) and discriminant validity.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Gonzalez-Robles, PhD student, Study chair, Universitat Juame I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790398
- Sponsor's protocol ID
- UJaumeI_Transd_PS
- Status last verified
- Mar 2016
- First submitted
- 23 May 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Up-regulation of Positive Affect in Emotional Disorders: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02790398
- Acronym / sponsor ID
- UJaumeI_Transd_PS
- Conditions
- Anxiety, Depression
- Keywords
- Transdiagnostic treatment protocol, Transdiagnostic treatment protocol + PA component
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Jun 2016 (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 differential effect of two transdiagnostic treatment protocols for emotional disorders (ED) (depression and anxiety disorders) using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol that also includes a specific component to address the regulation of positive affect (TTP+PA). Another aim was to assess the acceptability of both treatments by patients. It was hypothesized that the intervention would result in significant differences in favor of the TTP+PA protocol in all measures. Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted by the two groups of participants.
Detailed description
ED are highly prevalent mental disorders and one of the main causes of disability worldwide. Currently, there is evidence showing the efficacy of transdiagnostic treatments for anxiety disorders, and for comorbid depression and anxiety disorders. An important line of research within the transdiagnostic treatment of ED was initiated by D. H. Barlow. Barlow's theory of triple vulnerability emphasizes the underlying vulnerabilities that are common to ED and help to explain the comorbidity among these diverse conditions. A central aspect within this theoretical perspective is the role of emotion regulation in ED. The regulation of negative emotions in ED has received a great deal of attention in cognitive behavior therapy (CBT) research, and more recently in transdiagnostic ED models like the UP developed by Barlow's team. However, although Barlow underscored the role of low PA in the onset and maintenance of ED, the main objective of the treatment components in the UP is to train patients in negative affect (NA) regulation, but less attention has been paid to the inclusion of treatment components to directly target PA regulation. Moreover, literature has shown that higher levels of PA are associated with better physical and psychological health, healthier lifestyles, and better general functioning. Consequently, an important treatment goal from a transdiagnostic treatment approach would be to increase PA while decreasing NA.
The aim of this study is to compare the differential effect of two transdiagnostic treatment protocols for ED using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol that also includes a specific component to address the regulation of positive affect (TTP+PA). Another aim is to assess the acceptability of both treatments by patients. It was hypothesized that the intervention would result in significant differences in favor of the TTP+PA protocol in all measures. Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted by the two groups of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic treatment protocol | Experimental | Behavioral: Transdiagnostic treatment protocolTransdiagnostic treatment protocol. |
| Transdiagnostic treatment protocol + PA regulation component | Active comparator | Behavioral: Transdiagnostic treatment protocol + PA regulation componentTransdiagnostic treatment protocol that includes a component aimed at the regulation of PA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older
- meeting the DSM-IV diagnostic criteria for ED (major depression disorder, dysthimic disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, anxiety disorder not otherwise specified, unipolar mood disorder not otherwise specified)
- ability to understand and read Spanish
Key exclusion criteria (5 listed)
- bipolar disorder
- schizophrenia
- risk of suicide
- receiving another psychological treatment during the study
- in the case of receiving pharmacological treatment, an increase and/or change in this treatment during the study period (a decrease in pharmacological treatment is accepted)
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 treatment protocolTransdiagnostic treatment protocol for emotional disorders whose aims are to learn and practice adaptive ways to regulate 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. These components are organized in twelve modules. | Behavioural | Transdiagnostic treatment protocol |
| Transdiagnostic treatment protocol + PA regulation componentTransdiagnostic treatment protocol for emotional disorders + PA regulation components has the purpose of learning and practicing adaptive ways to regulate emotions from a transdiagnostic perspective. This protocol includes the same components but it also includes 4 additional modules focused specifically on the regulation of positive affectivity. | Behavioural | Transdiagnostic treatment protocol + PA regulation component |
Primary outcome
Change in the Positive and Negative Affect Scale (PANAS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.
Time frame: Up to 7 months
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.
3 secondary outcomes
Change in the Beck Depression Inventory II (BDI-II) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.
Time frame: Up to 7 months
Change in the Overall Anxiety Severity and Impairment Scale (OASIS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.
Time frame: Up to 7 months
Change in the Quality of Life Inventory (QLI) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.
Time frame: Up to 7 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 30 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
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.
Alberto Gonzalez-Robles, PhD student study chair
Universitat Juame I
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 treatment protocol and Transdiagnostic treatment protocol + PA regulation component in people with Anxiety and Depression, 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 3 inclusion and 5 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 30 Nov 2016. 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 Positive and Negative Affect Scale (PANAS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up. (time frame: Up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2016.