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OpenTrials
Completed

NCT Number: NCT06335589

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

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).

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Key information

Conditions

Stress Disorders, Post-Traumatic Behavior Mental Disorders Personal Satisfaction Psychological Well-Being Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EBP-Massed

Other

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

EBP-TAU

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

Secondary outcomes

  1. Session attendance

    Time frame: Post-treatment (weeks 0-20)

    The number of sessions attended of the assigned treatment

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Post-treatment (weeks 0-20)

    Self-reported depression; range = 0-27; higher scores = more severe symptoms

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 3 Month Follow Up

    Self-reported depression; range = 0-27; higher scores = more severe symptoms

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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