Clinical trial NCT06335589: Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment
Official title: Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment (CDA 21-191)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Stress Disorders, Post-Traumatic
Psychotherapy
Mental Health
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Treatment completion
timeFrame: Immediately after treatment completion or discontinuation (weeks 0-20)
measure: Acceptability of Intervention (AIM)
timeFrame: Immediately after treatment completion or discontinuation (weeks 0-20)
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Post-treatment (weeks 0-20)
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score
timeFrame: Post-treatment (weeks 0-20)
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score
timeFrame: 3 Month Follow up
Secondary outcomes:
measure: Session attendance
timeFrame: Post-treatment (weeks 0-20)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Post-treatment (weeks 0-20)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 Month Follow Up
measure: Brief Inventory of Psychosocial Functioning (BIPF)
timeFrame: Post-treatment (weeks 0-20)
measure: Brief Inventory of Psychosocial Functioning (BIPF)
timeFrame: 3 Month Follow up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Stephanie Y Wells, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References: