Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment

March 21, 2024 updated by: VA Office of Research and Development
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Laurel B Koss, MS OTR
  • Phone Number: 775648 (919) 286-0411
  • Email: laurel.koss@va.gov

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705-3875
        • Durham VA Medical Center, Durham, NC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephanie Y Wells, PhD MS BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBP-Massed
PTSD evidence-based psychotherapies are delivered in a massed format (e.g., intended be delivered at least three times per week).
Other: EBP-Massed
CPT or PE will be delivered in a massed format (e.g., sessions at least 3 days per week)
Active Comparator: EBP-TAU
PTSD evidence-based psychotherapies are delivered treatment as usual, which is typically once per week.
Other: EBP-TAU
CPT or PE will be delivered treatment as usual, which is typically once per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after treatment completion or discontinuation (weeks 0-20)
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
Immediately after treatment completion or discontinuation (weeks 0-20)
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
Post-treatment (weeks 0-20)
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.
Post-treatment (weeks 0-20)
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.
3 Month Follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Session attendance
Time Frame: Post-treatment (weeks 0-20)
The number of sessions attended of the assigned treatment
Post-treatment (weeks 0-20)
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Post-treatment (weeks 0-20)
Self-reported depression; range = 0-27; higher scores = more severe symptoms
Post-treatment (weeks 0-20)
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 3 Month Follow Up
Self-reported depression; range = 0-27; higher scores = more severe symptoms
3 Month Follow Up
Brief Inventory of Psychosocial Functioning (BIPF)
Time Frame: Post-treatment (weeks 0-20)
PTSD-related psychosocial functioning; higher scores = more functional impairment. Items are scored on a Likert scale from 0 (never) to 6 (always). Participants are instructed to skip any item that does not reflect a domain that they have participated in over the past 30 days. The B-IPF is scored by summing the scored items to create a total score, dividing the total score by the maximum possible score based on the number of items scored, and multiplying by 100.
Post-treatment (weeks 0-20)
Brief Inventory of Psychosocial Functioning (BIPF)
Time Frame: 3 Month Follow up
PTSD-related psychosocial functioning; higher scores = more functional impairment. Items are scored on a Likert scale from 0 (never) to 6 (always). Participants are instructed to skip any item that does not reflect a domain that they have participated in over the past 30 days. The B-IPF is scored by summing the scored items to create a total score, dividing the total score by the maximum possible score based on the number of items scored, and multiplying by 100.
3 Month Follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Stephanie Y Wells, PhD MS BA, Durham VA Medical Center, Durham, NC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 17, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX 24-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Disorders, Post-Traumatic

Clinical Trials on EBP-Massed

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe