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Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder (CPTVTEL)

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ClinicalTrials.gov Identifier: NCT00879255
Recruitment Status : Completed
First Posted : April 9, 2009
Results First Posted : March 2, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The immediate objective of this project was to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention (Cognitive Processing Therapy; CPT) to rural OIF/OEF Reservists, National Guardsmen, and veterans suffering with PTSD.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Cognitive Processing Therapy Group Videoteleconference Behavioral: Cognitive Processing Therapy Group In-Person Phase 3

Detailed Description:
The project was a 5-year prospective randomized clinical trial which conducted a direct comparison of the VTC and in-person modalities using rigorous methodology and a sophisticated analysis of equivalency between clinical and process outcome domains. In addition, cost effectiveness of this modality will be addressed. Approximately 130 combat Reservists, National Guardsmen, or veterans were recruited from multiple clinical sites. Prospective participants received a comprehensive assessment 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 was delivered twice a week over 6 weeks by a doctoral level psychologist. Quality control procedures were incorporated into the study's design to ensure integrity, fidelity and standard administration of the CPT intervention across both conditions. Participants received additional assessments at mid-treatment, immediately post-treatment, and at 3 and 6 months post-treatment. Outcome domains include: 1) clinical outcomes (symptom severity, social functioning); 2) process outcomes (perception of treatment, satisfaction, group therapy alliance, treatment compliance, and attrition and treatment credibility); and (3) cost-effectiveness outcomes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With PTSD
Study Start Date : October 2008
Primary Completion Date : September 2013
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Videoteleconferencing CPT

The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.

Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.

Behavioral: Cognitive Processing Therapy Group Videoteleconference
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Other Name: CPT-VT
Active Comparator: Face-to-Face CPT

The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.

Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.

Behavioral: Cognitive Processing Therapy Group In-Person
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Other Name: CPT-NP



Primary Outcome Measures :
  1. Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) [ Time Frame: Post-treatment (two-weeks following end of treatment) ]
    The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.

  2. Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) [ Time Frame: 3-month Post-treatment ]
    The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.

  3. Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) [ Time Frame: 6 months post-treatment ]
    The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of current combat related PTSD determined by the Clinician Administered PSTD Scale (CAPS-IV)
  • participants taking psychoactive medications have to have a stable regimen for at least 45 days prior to study entry

Exclusion Criteria:

  • active psychotic symptoms/disorder as determined by the SCID for DSM-IV
  • active homicidal or suicidal ideation as determined by the structured clinical interview
  • any significant cognitive impairment or history of Organic Mental Disorder as determined by the structured clinical interview
  • active (current) substance dependence as determined by the SCID (lifetime substance dependence/abuse not excluded)
  • unwillingness to refrain from substance abuse during treatment
  • female veterans

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879255


Locations
United States, Hawaii
VA Pacific Islands Health Care System, Honolulu, HI
Honolulu, Hawaii, United States, 96819-1522
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Leslie A Morland, PsyD VA Pacific Islands Health Care System, Honolulu, HI

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00879255     History of Changes
Obsolete Identifiers: NCT00769977
Other Study ID Numbers: DHI 07-259
2008-05_LM_Promise 0005 ( Other Identifier: VAPHICS IRB )
PT074516 ( Other Grant/Funding Number: CDMRP )
First Posted: April 9, 2009    Key Record Dates
Results First Posted: March 2, 2015
Last Update Posted: May 12, 2015
Last Verified: April 2015

Keywords provided by VA Office of Research and Development:
cognitive processing therapy
combat
veterans
PTSD
Telemental Health
Videoteleconference
outcome
Rural
Remote
CPT
VTC

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders