Clinical trial NCT04642898: Increasing Treatment Efficacy Using SMART Methods for Personalizing Care
Official title: Increasing Treatment Efficacy Using SMART Methods for Personalizing Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Post Traumatic Stress Disorder
Obsessive-Compulsive Disorder
Keywords: Unified Protocol
Cognitive Behavioral Therapy
Personalization
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-11-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Clinical Severity
timeFrame: 12 weeks (baseline, week 6 and week 12)
measure: Change in Self-Reported Anxiety Symptoms
timeFrame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
measure: Change in Self-Reported Depressive Symptoms
timeFrame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
measure: Change in Self-Reported Aversive Reactions to Emotions
timeFrame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
measure: Change in Clinician-Rated Anxiety Symptoms
timeFrame: 12 weeks (baseline, week 6 and week 12)
measure: Change in Clinician-Rated Depressive Symptoms
timeFrame: 12 weeks (baseline, week 6 and week 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Shannon Sauer-Zavala
role: PRINCIPAL_INVESTIGATOR
References: