Transdiagnostic Treatment Personalization

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder; Anxiety Disorders; Obsessive-Compulsive Disorder; Depressive Disorder
• Interventions: Behavioral: Capitalization UP Treatment; Behavioral: Standard UP Treatment; Behavioral: Compensation UP Treatment

• Registration Number: NCT04584879
• Lead Sponsor: Shannon E. Sauer-Zavala

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-28
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2020-10
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-06
• Last Update Submitted: 2020-10-06
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capitalization Group, Brief Intervention	Capitalization UP Treatment	Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Standard Group, Full Intervention	Standard UP Treatment	Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Compensation Group, Brief Intervention	Compensation UP Treatment	Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Capitalization Group, Full Intervention	Capitalization UP Treatment	Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Standard Group, Brief Intervention	Standard UP Treatment	Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Compensation Group, Full Intervention	Compensation UP Treatment	Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.

Primary Outcome Measures

Name	Time	Method
Change in Clinical Severity	12 weeks (baseline, week 6 and week 12)	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.
Change in Anxiety Symptoms	12 weeks (baseline, week 1, week, 2, week, 3.....week 12)	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.
Change in Depressive Symptoms	12 weeks (baseline, week 1, week, 2, week, 3.....week 12)	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.
Change in Aversive Reactions to Emotions	12 weeks (baseline, week 1, week, 2, week, 3.....week 12)	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.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States