Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy in-person
Cognitive Processing Therapy through videoteleconference
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
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.
Sites / Locations
- VA Pacific Islands Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control CPT
Experimental CPT via VTC
Arm Description
'Cognitive Processing Therapy in-person. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.
'Cognitive Processing Therapy through videoteleconference. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale (CAPS-IV)
Secondary Outcome Measures
Full Information
NCT ID
NCT02362477
First Posted
February 4, 2015
Last Updated
February 9, 2015
Sponsor
VA Pacific Islands Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT02362477
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Pacific Islands Health Care System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control CPT
Arm Type
Active Comparator
Arm Description
'Cognitive Processing Therapy in-person. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.
Arm Title
Experimental CPT via VTC
Arm Type
Experimental
Arm Description
'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
Intervention Name(s)
Cognitive Processing Therapy in-person
Other Intervention Name(s)
CPT-NP
Intervention Description
Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy through videoteleconference
Other Intervention Name(s)
CPT-VTC
Intervention Description
Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS-IV)
Time Frame
6 months post-treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie A. Morland, Psy.D.
Organizational Affiliation
VA Pacific Islands Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pacific Islands Healthcare System
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32077948
Citation
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.
Results Reference
derived
Learn more about this trial
Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
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