Transdiagnostic Treatment Personalization

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Shannon E. Sauer-Zavala
• Investigators: Principal Investigator: Shannon Sauer-Zavala, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Unified Protocol; Personalization
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Trauma and Stressor Related Disorders; Depressive Disorder; Disease; Obsessive-Compulsive Disorder; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 53545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No