Transdiagnostic Treatment Personalization
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedFirst Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedOctober 14, 2020
October 1, 2020
11 months
October 6, 2020
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
Study Arms (6)
Standard Group, Brief Intervention
EXPERIMENTALParticipants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Standard Group, Full Intervention
EXPERIMENTALParticipants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Capitalization Group, Brief Intervention
EXPERIMENTALParticipants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Capitalization Group, Full Intervention
EXPERIMENTALParticipants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
Compensation Group, Brief Intervention
EXPERIMENTALParticipants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Compensation Group, Full Intervention
EXPERIMENTALParticipants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
Interventions
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).
Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
Eligibility Criteria
You may qualify if:
- diagnosis of at least one emotional disorder
- fluent in English
- medication stability
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40506, United States
Related Publications (1)
Southward MW, Terrill DR, Sauer-Zavala S. The effects of the Unified Protocol and Unified Protocol skills on loneliness in the COVID-19 pandemic. Depress Anxiety. 2022 Dec;39(12):913-921. doi: 10.1002/da.23297. Epub 2022 Nov 13.
PMID: 36372958DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon Sauer-Zavala
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 14, 2020
Study Start
October 28, 2019
Primary Completion
September 15, 2020
Study Completion
September 15, 2020
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share