Transdiagnostic Treatment Personalization

Study Overview
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Brief Summary
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The primary purpose of this study is to explore whether the efficiency of treatment for anxiety and depressive disorders can be increased using two discrete strategies: personalized skill ordering and 2) treatment discontinuation based on proximal indicators of improvements. The present study will specifically use treatment components drawn from an evidence-based psychological intervention, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP). This intervention has strong empirical support for patients presenting with anxiety, depressive, and related disorders and contains therapeutic skills that are common in psychological interventions (e.g., psychoeducation, mindfulness training, cognitive restructuring, countering emotional avoidance, increasing interoceptive tolerance). This study will determine if prioritizing the order of treatment modules to capitalize on patient strengths or compensate for weakensses increases treatmen efficacy. Additionally, it will also identify under what conditions briefer treatment modules may be appropriate.

Official Title
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Transdiagnostic Treatment Personalization: Prioritizing Therapy Components to Capitalize on Strengths or Compensate for Weaknesses

Conditions
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Anxiety Disorders, Depressive Disorder, Post Traumatic Stress Disorder, Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Standard UP Treatment
* Behavioral: Capitalization UP Treatment
* Behavioral: Compensation UP Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of at least one emotional disorder fluent in English medication stability Exclusion Criteria: concurrent therapy psychological condition that would be better addressed by alternative treatments have received more than 5 sessions of cognitive behavioral therapy in the past 5 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Group, Brief Intervention<br>Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual. | Behavioral: Standard UP Treatment<br>* Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).<br>|
| Experimental: Standard Group, Full Intervention<br>Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual. | Behavioral: Standard UP Treatment<br>* Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).<br>|
| Experimental: Capitalization Group, Brief Intervention<br>Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths. | Behavioral: Capitalization UP Treatment<br>* Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.<br>|
| Experimental: Capitalization Group, Full Intervention<br>Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths. | Behavioral: Capitalization UP Treatment<br>* Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.<br>|
| Experimental: Compensation Group, Brief Intervention<br>Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses. | Behavioral: Compensation UP Treatment<br>* Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.<br>|
| Experimental: Compensation Group, Full Intervention<br>Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses. | Behavioral: Compensation UP Treatment<br>* Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Severity | Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity. | 12 weeks (baseline, week 6 and week 12) | 
| Change in Anxiety Symptoms | Anxiety symptoms will be measured using the Overall Anxiety Severity and Interference Scale (OASIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms. | 12 weeks (baseline, week 1, week, 2, week, 3.....week 12) | 
| Change in Depressive Symptoms | Depressive symptoms will be measured using the Overall Depression Severity and Interference Scale (ODSIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms. | 12 weeks (baseline, week 1, week, 2, week, 3.....week 12) | 
| Change in Aversive Reactions to Emotions | Aversive reactions to emotions will be measured using the distress aversion subscale of the Multidimensional Experiential Avoidance Questionnaire (MEAQ). This is a self-report measure in which scores range from 13-78; higher scores indicate greater negative reactions to emotional experiences. | 12 weeks (baseline, week 1, week, 2, week, 3.....week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unified Protocol, Cognitive Behavioral Therapy, Personalization