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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335589
• Other study ID #: CDX 24-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Stephanie Y Wells, PhD MS BA
• Phone: (919) 286-0411
• Email: stephanie.wells2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• EBP-Massed
CPT or PE will be delivered in a massed format (e.g., sessions at least 3 days per week)
• EBP-TAU
CPT or PE will be delivered treatment as usual, which is typically once per week.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment completion	Proportion of Veterans who complete a full course of an assigned PTSD treatment	Immediately after treatment completion or discontinuation (weeks 0-20)
Primary	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)
Primary	Client Satisfaction Questionnaire-8 (CSQ-8)	Veterans' perceived satisfaction of assigned treatment; range 8-32; greater scores = greater satisfaction	Post-treatment (weeks 0-20)
Primary	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)
Primary	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	Session attendance	The number of sessions attended of the assigned treatment	Post-treatment (weeks 0-20)
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Self-reported depression; range = 0-27; higher scores = more severe symptoms	Post-treatment (weeks 0-20)
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Self-reported depression; range = 0-27; higher scores = more severe symptoms	3 Month Follow Up
Secondary	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)
Secondary	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