Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

April 11, 2024 updated by: Shannon E. Sauer-Zavala
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Behavioral: 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).
Experimental: Standard Group, Full Intervention
Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual.
Behavioral: 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).
Experimental: Capitalization Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
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.
Experimental: Capitalization Group, Full Intervention
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths.
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.
Experimental: Compensation Group, Brief Intervention
Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
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.
Experimental: Compensation Group, Full Intervention
Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Severity
Time Frame: 12 weeks (baseline, week 6 and week 12)
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 Self-Reported Anxiety Symptoms
Time Frame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
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 Self-Reported Depressive Symptoms
Time Frame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
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 Self-Reported Aversive Reactions to Emotions
Time Frame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
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)
Change in Clinician-Rated Anxiety Symptoms
Time Frame: 12 weeks (baseline, week 6 and week 12)
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.
12 weeks (baseline, week 6 and week 12)
Change in Clinician-Rated Depressive Symptoms
Time Frame: 12 weeks (baseline, week 6 and week 12)
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.
12 weeks (baseline, week 6 and week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shannon E. Sauer-Zavala

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Shannon Sauer-Zavala, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59307
  • R34MH123601-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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