Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

Shannon E. Sauer-Zavala

Status: Completed

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

Treatments: Behavioral: Compensation UP Treatment; Behavioral: Capitalization UP Treatment; Behavioral: Standard UP Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04642898

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

59307

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 6 patient groups

Standard Group, Brief Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Standard UP Treatment

Standard Group, Full Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Standard UP Treatment

Capitalization Group, Brief Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Capitalization UP Treatment

Capitalization Group, Full Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Capitalization UP Treatment

Compensation Group, Brief Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Compensation UP Treatment

Compensation Group, Full Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Compensation UP Treatment