Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
2 other identifiers
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 13, 2015
CompletedFebruary 13, 2015
February 1, 2015
4.3 years
February 4, 2015
February 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Clinician Administered PTSD Scale (CAPS-IV)
6 months post-treatment
Study Arms (2)
Control CPT
ACTIVE COMPARATOR'Cognitive Processing Therapy in-person. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.
Experimental CPT via VTC
EXPERIMENTAL'Cognitive Processing Therapy through videoteleconference. Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.
Interventions
Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.
Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Pacific Islands Healthcare System
Honolulu, Hawaii, 96819, United States
Related Publications (1)
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.
PMID: 32077948DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie A. Morland, Psy.D.
VA Pacific Islands Healthcare System
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2015
First Posted
February 13, 2015
Study Start
September 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 13, 2015
Record last verified: 2015-02