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

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

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: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Other: EBP-Massed; Other: EBP-TAU

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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)	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)	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	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	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	The number of sessions attended of the assigned treatment	Post-treatment (weeks 0-20)
Patient Health Questionnaire-9 (PHQ-9)	Self-reported depression; range = 0-27; higher scores = more severe symptoms	Post-treatment (weeks 0-20)
Patient Health Questionnaire-9 (PHQ-9)	Self-reported depression; range = 0-27; higher scores = more severe symptoms	3 Month Follow Up
Brief Inventory of Psychosocial Functioning (BIPF)	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)	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

• 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

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): September 15, 2025
• Study Completion (Actual): September 15, 2025

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): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Veterans; Stress Disorders, Post-Traumatic; Psychotherapy
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Behavior; Personal Satisfaction; Stress Disorders, Post-Traumatic; Psychological Well-Being
• 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