Transdiagnostic Treatment Personalization

NCT ID: NCT04584879

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2020-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Disorders Depressive Disorder Post Traumatic Stress Disorder Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard Group, Brief Intervention

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

Group Type EXPERIMENTAL

Standard UP Treatment

Intervention Type 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).

Standard Group, Full Intervention

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

Group Type EXPERIMENTAL

Standard UP Treatment

Intervention Type 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 Group, Brief Intervention

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

Group Type EXPERIMENTAL

Capitalization UP Treatment

Intervention Type 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.

Capitalization Group, Full Intervention

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

Group Type EXPERIMENTAL

Capitalization UP Treatment

Intervention Type 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 Group, Brief Intervention

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

Group Type EXPERIMENTAL

Compensation UP Treatment

Intervention Type 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.

Compensation Group, Full Intervention

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

Group Type EXPERIMENTAL

Compensation UP Treatment

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shannon E. Sauer-Zavala

OTHER

Sponsor Role lead

Responsible Party

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Shannon E. Sauer-Zavala

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shannon Sauer-Zavala

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36372958 (View on PubMed)

Other Identifiers

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53545

Identifier Type: -

Identifier Source: org_study_id

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