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Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

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ClinicalTrials.gov Identifier: NCT04642898
Recruitment Status : Enrolling by invitation
First Posted : November 24, 2020
Last Update Posted : March 13, 2023
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Shannon E. Sauer-Zavala, University of Kentucky

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Post Traumatic Stress Disorder Obsessive-Compulsive Disorder Behavioral: Standard UP Treatment Behavioral: Capitalization UP Treatment Behavioral: Compensation UP Treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Increasing Treatment Efficacy Using SMART Methods for Personalizing Care
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642898


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
Shannon E. Sauer-Zavala
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Shannon Sauer-Zavala University of Kentucky
More Information
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Responsible Party: Shannon E. Sauer-Zavala, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04642898    
Other Study ID Numbers: 59307
R34MH123601-01 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shannon E. Sauer-Zavala, University of Kentucky:
Unified Protocol
Cognitive Behavioral Therapy
Personalization
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Anxiety Disorders
Stress Disorders, Post-Traumatic
 Obsessive-Compulsive Disorder
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders