Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

Sponsor

Shannon E. Sauer-Zavala (Other)

Overall Status

Recruiting

CT.gov ID

NCT04642898

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

25.3

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 22, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

Primary Outcome Measures

Change in Clinical Severity [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.
Change in Self-Reported Anxiety Symptoms [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.
Change in Self-Reported Depressive Symptoms [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.
Change in Self-Reported Aversive Reactions to Emotions [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.
Change in Clinician-Rated Anxiety Symptoms [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.
Change in Clinician-Rated Depressive Symptoms [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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