Up-regulating Positive Affect in Emotional Disorders

Study Overview
=================
Brief 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 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.

Official Title
-----------------
Transdiagnostic Up-regulation of Positive Affect in Emotional Disorders: A Randomized Pilot Study

Conditions
-----------------
Anxiety, Depression

Intervention / Treatment
-----------------
* Behavioral: Transdiagnostic treatment protocol
* Behavioral: Transdiagnostic treatment protocol + PA regulation component


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria:+ 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdiagnostic treatment protocol<br>Transdiagnostic treatment protocol. | Behavioral: Transdiagnostic treatment protocol<br>* 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.<br>|
| Active Comparator: Transdiagnostic treatment protocol + PA regulation component<br>Transdiagnostic treatment protocol that includes a component aimed at the regulation of PA. | Behavioral: Transdiagnostic treatment protocol + PA regulation component<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transdiagnostic treatment protocol, Transdiagnostic treatment protocol + PA component