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OpenTrials
Completed

NCT Number: NCT04584879

Transdiagnostic Treatment Personalization

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.

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Key information

Conditions

Anxiety Disorders Depressive Disorder Mental Disorders Mood Disorders Obsessive-Compulsive Disorder Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard UP Treatment

Behavioral

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).

Capitalization UP Treatment

Behavioral

Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.

Compensation UP Treatment

Behavioral

Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Shannon E. Sauer-Zavala

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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