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Clinical Trials/NCT06335589
NCT06335589
Completed
Not Applicable

Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment (CDA 21-191)

VA Office of Research and Development1 site in 1 country30 target enrollmentJune 24, 2024

Overview

Phase
Not Applicable
Intervention
EBP-Massed
Conditions
Stress Disorders, Post-Traumatic
Sponsor
VA Office of Research and Development
Enrollment
30
Locations
1
Primary Endpoint
Acceptability of Intervention (AIM)
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).

Registry
clinicaltrials.gov
Start Date
June 24, 2024
End Date
September 15, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Veterans aged 18 years or older;
  • meets criteria for current PTSD;
  • willingness to be randomized to either condition (e.g., EBP-Massed or EBP-TAU);
  • decision to receive CPT or PE in a treatment planning session with a Durham Trauma Recovery Program clinic provider;
  • ability to provide informed consent

Exclusion Criteria

  • High acute suicide risk;
  • active manic symptoms that would likely interfere with treatment;
  • active psychotic symptoms that would likely interfere with treatment;
  • currently in a concurrent trauma-focused evidence-based treatment for PTSD

Arms & Interventions

EBP-Massed

PTSD evidence-based psychotherapies are delivered in a massed format (e.g., intended be delivered at least three times per week).

Intervention: EBP-Massed

EBP-TAU

PTSD evidence-based psychotherapies are delivered treatment as usual, which is typically once per week.

Intervention: EBP-TAU

Outcomes

Primary Outcomes

Acceptability of Intervention (AIM)

Time Frame: Immediately after treatment completion or discontinuation (weeks 0-20)

Veterans' perceived acceptability of massed treatment for PTSD; scale score ranges from 1-5; greater score = greater acceptability

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score

Time Frame: 3 Month Follow up

PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.

Treatment completion

Time Frame: Immediately after treatment completion or discontinuation (weeks 0-20)

Proportion of Veterans who complete a full course of an assigned PTSD treatment

Client Satisfaction Questionnaire-8 (CSQ-8)

Time Frame: Post-treatment (weeks 0-20)

Veterans' perceived satisfaction of assigned treatment; range 8-32; greater scores = greater satisfaction

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score

Time Frame: Post-treatment (weeks 0-20)

PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.

Secondary Outcomes

  • Brief Inventory of Psychosocial Functioning (BIPF)(3 Month Follow up)
  • Session attendance(Post-treatment (weeks 0-20))
  • Patient Health Questionnaire-9 (PHQ-9)(3 Month Follow Up)
  • Patient Health Questionnaire-9 (PHQ-9)(Post-treatment (weeks 0-20))
  • Brief Inventory of Psychosocial Functioning (BIPF)(Post-treatment (weeks 0-20))

Study Sites (1)

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