Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Shannon E. Sauer-Zavala
Study ID
NCT04642898
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Standard UP Treatment — BEHAVIORAL
    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).
  • Capitalization UP Treatment — BEHAVIORAL
    Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
  • Compensation UP Treatment — BEHAVIORAL
    Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.

Study Details

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.

Key Dates

Start date
Jun 22, 2021
Status verified
Jul 2025
Primary completion
Jun 15, 2024
Completion
Jun 15, 2024

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • Experimental: Capitalization Group, Brief Intervention
    Participants in this group will receive 6 sessions of treatment 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.
  • Experimental: Compensation Group, Brief Intervention
    Participants in this group will receive 6 sessions of treatment 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.

Primary Outcome Measure

Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention) [ Time Frame: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506-

Find similar trials in Lexington, KY

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Kentucky· Lexington, KY

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