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

NCT ID: NCT06335589

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2025-09-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EBP-Massed

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

Group Type: EXPERIMENTAL

EBP-Massed

Intervention Type: OTHER

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

EBP-TAU

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

Group Type: ACTIVE_COMPARATOR

EBP-TAU

Intervention Type: OTHER

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

Interventions

EBP-Massed

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

Intervention Type: OTHER

EBP-TAU

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Y Wells, PhD MS BA

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CDX 24-002

Identifier Type: -

Identifier Source: org_study_id