Clinical trial NCT00879255: Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder
Official title: Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Posttraumatic Stress Disorder
Keywords: cognitive processing therapy
combat
veterans
PTSD
Telemental Health
Videoteleconference
outcome
Rural
Remote
CPT
VTC
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-04-09
Enrollment: 125
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
timeFrame: Post-treatment (two-weeks following end of treatment)
measure: Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
timeFrame: 3-month Post-treatment
measure: Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
timeFrame: 6 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: VA Pacific Islands Health Care System, Honolulu, HI
state: Hawaii
Study officials:
affiliation: VA Pacific Islands Health Care System, Honolulu, HI
name: Leslie A Morland, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morland LA, Greene CJ, Rosen C, Mauldin PD, Frueh BC. Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD. Contemp Clin Trials. 2009 Nov;30(6):513-22. doi: 10.1016/j.cct.2009.06.006. Epub 2009 Jul 1.
citation: Morland LA, Hynes AK, Mackintosh MA, Resick PA, Chard KM. Group cognitive processing therapy delivered to veterans via telehealth: a pilot cohort. J Trauma Stress. 2011 Aug;24(4):465-9. doi: 10.1002/jts.20661. Epub 2011 Jul 25.
citation: Morland LA, Mackintosh MA, Greene CJ, Rosen CS, Chard KM, Resick P, Frueh BC. Cognitive processing therapy for posttraumatic stress disorder delivered to rural veterans via telemental health: a randomized noninferiority clinical trial. J Clin Psychiatry. 2014 May;75(5):470-6. doi: 10.4088/JCP.13m08842.
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.
citation: Raab PA, Mackintosh MA, Gros DF, Morland LA. Examination of the Content Specificity of Posttraumatic Cognitions in Combat Veterans With Posttraumatic Stress Disorder. Psychiatry. 2015;78(4):328-40. doi: 10.1080/00332747.2015.1082337.
citation: Raab PA, Mackintosh MA, Gros DF, Morland LA. Impact of comorbid depression on quality of life in male combat Veterans with posttraumatic stress disorder. J Rehabil Res Dev. 2015;52(5):563-76. doi: 10.1682/JRRD.2014.05.0130.