Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD

NCT ID: NCT02362477

Last Updated: 2015-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-12-31

Brief Summary

The immediate objective of this project is to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention to female rural veterans, Reservists, National Guardsmen, and civilians suffering with PTSD. This study is an expansion, seeking to add a treatment arm of women, to an already CDMRP-funded study that completed in July 2014 treating male combat veterans with military-related PTSD. The long-term objective of this project is to disseminate an empirically sound TMH PTSD protocol for male and female veterans, Reserve and Guard that will extend the use of CPT to remote rural sites. It is hypothesized that using VTC, will be as effective as the in-person mode of service delivery for providing CPT.

Detailed Description

This expansion is a 4-year RCT, plus a 1 year no-cost extension, which provides a direct comparison of the VTC and in-person modalities using rigorous methodology and a sophisticated analysis of treatment equivalency in clinical and process outcome domains. Outcome domains include clinical and process outcomes. Approximately 154 female veterans, Reservists, National Guardsmen, or civilians with PTSD have been recruited from multiple VA clinical sites and community health centers (for N=110 completers). Consistent with the male combat veterans CPT study, prospective participants received a comprehensive assessment battery at baseline to determine eligibility. The exclusion criteria selected are consistent with large PTSD randomized clinical trials as well as research using the CPT protocol with military populations with PTSD. The treatment is delivered up to twice a week for up to 12 weeks by a doctoral level psychologist. Quality control procedures have been incorporated into the study's design to ensure integrity, fidelity and standard administration of the CPT intervention across both conditions. It is expected that the results from this project can be applied to other VA and military locations, where similar specialized PTSD clinical services are needed but unavailable due to geographic barriers.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control CPT

'Cognitive Processing Therapy in-person. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.

Group Type: ACTIVE_COMPARATOR

Cognitive Processing Therapy in-person

Intervention Type: BEHAVIORAL

Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.

Experimental CPT via VTC

'Cognitive Processing Therapy through videoteleconference. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.

Group Type: EXPERIMENTAL

Cognitive Processing Therapy through videoteleconference

Intervention Type: BEHAVIORAL

Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.

Interventions

Cognitive Processing Therapy in-person

Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.

Intervention Type: BEHAVIORAL

Cognitive Processing Therapy through videoteleconference

Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.

Intervention Type: BEHAVIORAL

Other Intervention Names

CPT-NP; CPT-VTC

Eligibility Criteria

Inclusion Criteria

• diagnosis of current PTSD established by the Clinician-Administered PTSD Scale (CAPS) and
• a stable psychotropic medication regimen for a minimum of 45 days prior to study entry for those taking such medications.

Exclusion Criteria

• significant cognitive impairment or history of organic mental disorder,
• active psychotic symptoms/disorder,
• active homicidal or suicidal ideation,
• current substance dependence, and
• unwillingness to refrain from substance abuse during treatment.

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

Sponsors

VA Pacific Islands Health Care System

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie A. Morland, Psy.D.

Role: PRINCIPAL_INVESTIGATOR

VA Pacific Islands Healthcare System

Locations

VA Pacific Islands Healthcare System

Honolulu, Hawaii, United States

Countries

United States

References

Glassman LH, Mackintosh MA, Wells SY, Wickramasinghe I, Walter KH, Morland LA. Predictors of Quality of Life Following Cognitive Processing Therapy Among Women and Men With Post-Traumatic Stress Disorder. Mil Med. 2020 Jun 8;185(5-6):e579-e585. doi: 10.1093/milmed/usz474.

Reference Type: DERIVED

PMID: 32077948 (View on PubMed)

Other Identifiers

PT090552

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W81XWH-10-1-1037

Identifier Type: -

Identifier Source: org_study_id