Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder (PTSD) (CPT V-Tel)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00879255
First received: April 7, 2009
Last updated: October 15, 2014
Last verified: October 2014
  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 (Cognitive Processing Therapy; CPT) to rural OIF/OEF Reservists, National Guardsmen, and veterans suffering with PTSD.


Condition Intervention Phase
Posttraumatic Stress Disorder
Behavioral: Cognitive Processing Group Therapy Through Videoteleconference
Behavioral: Cognitive Processing Group Therapy In-Person
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PCL-M, CAPS (symptom severity); QOLI (social functioning) [ Time Frame: Baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CAPS (symptom severity) [ Time Frame: Baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
  • PCL-M (PTSD checklist) [ Time Frame: Baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
  • QOLI (social functioning) [ Time Frame: Baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: October 2008
Study Completion Date: June 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control CPT
Cognitive Processing Group Therapy provided in-person
Behavioral: Cognitive Processing Group Therapy 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
Experimental: Experimental CPT via VTC
Cognitive Processing Group Therapy provided through videoteleconference technology.
Behavioral: Cognitive Processing Group Therapy Through Videoteleconference
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Other Name: CPT-VT

Detailed Description:

The project is a 5-year prospective randomized clinical trial which conducts 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879255

Locations
United States, Hawaii
VA Pacific Islands Health Care System
Honolulu, Hawaii, United States, 96819-1522
Sponsors and Collaborators
Investigators
Principal Investigator: Leslie A Morland, PSYD VA Pacific Islands Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00879255     History of Changes
Obsolete Identifiers: NCT00769977
Other Study ID Numbers: DHI 07-259, 2008-05_LM_Promise 0005, PT074516
Study First Received: April 7, 2009
Last Updated: October 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cognitive processing therapy
combat
veterans
PTSD
Telemental Health
Videoteleconference
outcome
Rural
Remote
CPT
VTC

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014