Expired Study
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Honolulu, Hawaii 96819


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

W81XWH-10-1-1037


NCT ID:

NCT02362477


Secondary ID:

PT090552


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Pacific Islands Health Care System


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

126


Enrollment Type:

Actual


Overall Contact Information

Official Name:Leslie A. Morland, Psy.D.
Principal Investigator
VA Pacific Islands Healthcare System

Study Dates

Start Date:September 2010
Completion Date:December 2014
Completion Type:Actual
Primary Completion Date:December 2014
Primary Completion Type:Actual
Verification Date:February 2015
Last Changed Date:February 9, 2015
First Received Date:February 4, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Clinician Administered PTSD Scale (CAPS-IV)
Time Frame:6 months post-treatment
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive Processing Therapy in-person
Description:Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.
Arm Name:Control CPT
Other Name:CPT-NP
Intervention Type:Behavioral
Name:Cognitive Processing Therapy through videoteleconf
Description:Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.
Arm Name:Experimental CPT via VTC
Other Name:CPT-VTC

Study Arms

Study Arm Type:Experimental
Arm Name:Experimental CPT via VTC
Description:'Cognitive Processing Therapy through videoteleconference. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.
Study Arm Type:Active Comparator
Arm Name:Control CPT
Description:'Cognitive Processing Therapy in-person. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Pacific Islands Health Care System

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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