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Transdiagnostic Treatment Personalization

Primary Purpose

Anxiety Disorders, Depressive Disorder, Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard UP Treatment
Capitalization UP Treatment
Compensation UP Treatment
Sponsored by
Shannon E. Sauer-Zavala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Unified Protocol, Cognitive Behavioral Therapy, Personalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Standard Group, Brief Intervention

Standard Group, Full Intervention

Capitalization Group, Brief Intervention

Capitalization Group, Full Intervention

Compensation Group, Brief Intervention

Compensation Group, Full Intervention

Arm Description

Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.

Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.

Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.

Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.

Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.

Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
October 6, 2020
Sponsor
Shannon E. Sauer-Zavala
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1. Study Identification

Unique Protocol Identification Number
NCT04584879
Brief Title
Transdiagnostic Treatment Personalization
Official Title
Transdiagnostic Treatment Personalization: Prioritizing Therapy Components to Capitalize on Strengths or Compensate for Weaknesses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shannon E. Sauer-Zavala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depressive Disorder, Post Traumatic Stress Disorder, Obsessive-Compulsive Disorder
Keywords
Unified Protocol, Cognitive Behavioral Therapy, Personalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Group, Brief Intervention
Arm Type
Experimental
Arm Description
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Arm Title
Standard Group, Full Intervention
Arm Type
Experimental
Arm Description
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Arm Title
Capitalization Group, Brief Intervention
Arm Type
Experimental
Arm Description
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Arm Title
Capitalization Group, Full Intervention
Arm Type
Experimental
Arm Description
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Arm Title
Compensation Group, Brief Intervention
Arm Type
Experimental
Arm Description
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Arm Title
Compensation Group, Full Intervention
Arm Type
Experimental
Arm Description
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Intervention Type
Behavioral
Intervention Name(s)
Standard UP Treatment
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Capitalization UP Treatment
Intervention Description
Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
Intervention Type
Behavioral
Intervention Name(s)
Compensation UP Treatment
Intervention Description
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 Outcome Measure Information:
Title
Change in Clinical Severity
Description
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.
Time Frame
12 weeks (baseline, week 6 and week 12)
Title
Change in Anxiety Symptoms
Description
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.
Time Frame
12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Title
Change in Depressive Symptoms
Description
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.
Time Frame
12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Title
Change in Aversive Reactions to Emotions
Description
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.
Time Frame
12 weeks (baseline, week 1, week, 2, week, 3.....week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Sauer-Zavala
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transdiagnostic Treatment Personalization

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