Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

NCT04642898 | Completed Results

• 2 other identifiers: 59307R34MH123601-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

Unified Protocol; Cognitive Behavioral Therapy; Personalization

Outcome Measures

Primary Outcomes (6)

• Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)

  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. Negative scores indicate symptom improvement.

  Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention

• Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)

  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. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported

  Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)

• Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)

  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. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported

  Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)

• Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)

  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. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported

  Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)

• Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)

  Clinician-rated anxiety symptoms will be measured using the Hamilton Rating Scale for Anxiety Symptoms. Scores range from 0-56; higher scores indicate greater severity. Negative scores indicate symptom improvement. Outcomes for participants in brief intervention groups is the difference in clinician rated symptom scores before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in clinician rated symptom scores before and after 12 sessions.

  Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)

• Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)

  Clinician-rated depressive symptoms will be measured using the Hamilton Rating Scale for Depressive Symptoms. Scores range from 0-68; higher scores indicate greater severity. Negative scores indicate symptom improvement. Outcomes for participants in brief intervention groups is the difference in Clinician-Rated symptom scores before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in Clinician-Rated symptom scores before and after 12 sessions.

  Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)

Study Arms (6)

Standard Group, Brief Intervention

EXPERIMENTAL

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

Behavioral: Standard UP Treatment

Standard Group, Full Intervention

EXPERIMENTAL

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

Behavioral: Standard UP Treatment

Capitalization Group, Brief Intervention

EXPERIMENTAL

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

Behavioral: Capitalization UP Treatment

Capitalization Group, Full Intervention

EXPERIMENTAL

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

Behavioral: Capitalization UP Treatment

Compensation Group, Brief Intervention

EXPERIMENTAL

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

Behavioral: Compensation UP Treatment

Compensation Group, Full Intervention

EXPERIMENTAL

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

Behavioral: Compensation UP Treatment

Interventions

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).

Standard Group, Brief Intervention; Standard Group, Full Intervention

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.

Capitalization Group, Brief Intervention; Capitalization Group, Full Intervention

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.

Compensation Group, Brief Intervention; Compensation Group, Full Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Shannon E. Sauer-Zavala: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Dr. Sauer-Zavala
• Organization: University of Kentucky

ssz@uky.edu

859-562-1571

Study Officials

• Shannon Sauer-Zavala

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: November 18, 2020
• First Posted: November 24, 2020
• Study Start: June 22, 2021
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)