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

NCT06335589 | Completed

• 1 other identifier: CDX 24-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress Disorders, Post-Traumatic

Keywords

Stress Disorders, Post-Traumatic; Psychotherapy; Mental Health; Veterans

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Session attendance

  Post-treatment (weeks 0-20)

• Patient Health Questionnaire-9 (PHQ-9)

  Post-treatment (weeks 0-20)

• Patient Health Questionnaire-9 (PHQ-9)

  3 Month Follow Up

• Brief Inventory of Psychosocial Functioning (BIPF)

  Post-treatment (weeks 0-20)

• Brief Inventory of Psychosocial Functioning (BIPF)

  3 Month Follow up

Study Arms (2)

EBP-Massed

EXPERIMENTAL

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

Other: EBP-Massed

EBP-TAU

ACTIVE COMPARATOR

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

Other: EBP-TAU

Interventions

EBP-Massed OTHER

CPT or PE will be delivered in a massed format (e.g., sessions at least 3 days per week)

EBP-Massed

EBP-TAU OTHER

CPT or PE will be delivered treatment as usual, which is typically once per week.

EBP-TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Stephanie Y Wells, PhD MS BA

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical interviewers who assess primary outcomes will not be informed of participant's randomization assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Massed PTSD treatment (e.g., cognitive processing therapy \[CPT\] or prolonged exposure \[PE\] therapy delivered at least 3 times per week) will be compared to CPT \& PE delivered as usual, which is usually once per week.

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 28, 2024
• Study Start: June 24, 2024
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)