Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

NCT ID: NCT04642898

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2024-06-15

Brief Summary

The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate the effects of this personalized care. A sample of 60 participants with heterogeneous anxiety disorders (and comorbid conditions, including depression) will be enrolled in a pilot sequential multiple assignment randomized trial (SMART). Patients will be randomly assigned to one of three sequencing conditions: transdiagnostic treatment administered in its standard module order, module sequences that prioritize capitalizing on relative strengths, and module sequences that prioritize compensating for relative weaknesses. Next, after 6 sessions, participants will be randomly assigned to either continue or discontinue treatment to evaluate post-treatment change at varying levels of target engagement. This proposal will enable us to 1) test the feasibility, acceptability, and tolerability of the research protocol, treatment sequencing conditions, and early treatment discontinuation, 2) determine whether a preliminary signal that capitalization or compensation module sequencing improves treatment efficiency exists, and 3) explore preliminary associations between core process engagement at treatment discontinuation and later symptom improvement. The proposed study, and the subsequent research it will support, will inform evidence-based decision rules to make existing treatments more efficient, ultimately reducing patient costs and increasing the mental health service system's capacity to address the needs of more individuals.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Inclusion Criteria

• diagnosis of at least one anxiety disorder, trauma- or stressor-related disorder, or obsessive-compulsive 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

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Shannon E. Sauer-Zavala

OTHER

Sponsor Role: lead

Responsible Party

Shannon E. Sauer-Zavala

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shannon Sauer-Zavala

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R34MH123601-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

59307

Identifier Type: -

Identifier Source: org_study_id