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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06335589
Enrollment
30
Registered
2024-03-28
Start date
2024-06-24
Completion date
2025-09-15
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

Keywords

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

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).

Interventions

OTHEREBP-Massed

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

OTHEREBP-TAU

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Treatment completionImmediately after treatment completion or discontinuation (weeks 0-20)Proportion of Veterans who complete a full course of an assigned PTSD treatment
Acceptability of Intervention (AIM)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
Client Satisfaction Questionnaire-8 (CSQ-8)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 ScorePost-treatment (weeks 0-20)PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026