Transdiagnostic Treatment Personalization

Sponsor

Shannon E. Sauer-Zavala (Other)

Overall Status

Completed

CT.gov ID

NCT04584879

Collaborator

(none)

Enrollment

Location

Arms

10.6

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Depressive Disorder Post Traumatic Stress Disorder Obsessive-Compulsive Disorder	Behavioral: Standard UP Treatment Behavioral: Capitalization UP Treatment Behavioral: Compensation UP Treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 28, 2019

Actual Primary Completion Date :

Sep 15, 2020

Actual Study Completion Date :

Sep 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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