search
Back to results

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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy Group Videoteleconference
Cognitive Processing Therapy Group In-Person
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring cognitive processing therapy, combat, veterans, PTSD, Telemental Health, Videoteleconference, outcome, Rural, Remote, CPT, VTC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • VA Pacific Islands Health Care System, Honolulu, HI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Videoteleconferencing CPT

Face-to-Face CPT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
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.
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
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.
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
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.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2009
Last Updated
April 23, 2015
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT00879255
Brief Title
Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder
Acronym
CPTVTEL
Official Title
Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
cognitive processing therapy, combat, veterans, PTSD, Telemental Health, Videoteleconference, outcome, Rural, Remote, CPT, VTC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Videoteleconferencing CPT
Arm Type
Experimental
Arm Description
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.
Arm Title
Face-to-Face CPT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy Group Videoteleconference
Other Intervention Name(s)
CPT-VT
Intervention Description
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy Group In-Person
Other Intervention Name(s)
CPT-NP
Intervention Description
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
Description
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.
Time Frame
Post-treatment (two-weeks following end of treatment)
Title
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
Description
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.
Time Frame
3-month Post-treatment
Title
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
Description
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.
Time Frame
6 months post-treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie A Morland, PsyD
Organizational Affiliation
VA Pacific Islands Health Care System, Honolulu, HI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pacific Islands Health Care System, Honolulu, HI
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819-1522
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19576299
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.
Results Reference
result
PubMed Identifier
21793047
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.
Results Reference
result
PubMed Identifier
24922484
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.
Results Reference
result
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
PubMed Identifier
26745686
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.
Results Reference
derived
PubMed Identifier
26466310
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs