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Clinical Trials/NCT06335589
NCT06335589CompletedNot 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 enrollmentStarted: June 24, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Acceptability of Intervention (AIM)

Study 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Clinical interviewers who assess primary outcomes will not be informed of participant's randomization assignment.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Experimental

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

Intervention: EBP-Massed (Other)

EBP-TAU

Active Comparator

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

Intervention: EBP-TAU (Other)

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))

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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