Transdiagnostic Treatment Personalization

Overview

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.

Full Title of Study: “Transdiagnostic Treatment Personalization: Prioritizing Therapy Components to Capitalize on Strengths or Compensate for Weaknesses”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 15, 2020

Interventions

  • 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).
  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • Experimental: Capitalization Group, Brief Intervention
    • Participants in this group will receive 6 sessions of treatment 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.
  • Experimental: Compensation Group, Brief Intervention
    • Participants in this group will receive 6 sessions of treatment 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Clinical Severity
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shannon E. Sauer-Zavala
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Shannon E. Sauer-Zavala, Assistant Professor – University of Kentucky
  • Overall Official(s)
    • Shannon Sauer-Zavala, Principal Investigator, University of Kentucky

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