Trial Outcomes & Findings for Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder (NCT NCT00879255)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

125 participants

Primary outcome timeframe

Post-treatment (two-weeks following end of treatment)

Results posted on

2015-05-12

Participant Flow

This study included 13 group cohorts plus 1 pilot group cohort. Not counting the cohort 1 pilot, approximately 246 combat Reservists, National Guardsmen, or Veterans from multiple VA Pacific Island Health Care System clinical sites were assessed for eligibility, and 125 were subsequently randomized into treatment groups.

Not counting the cohort 1 pilot group, approximately 246 combat Reservists, National Guardsmen, or Veterans received a comprehensive assessment at baseline to determine eligibility. 144 met inclusion criteria, 19 declined participation, for 125 ITT who were randomized into treatment groups.

Participant milestones

Participant milestones
Measure	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. Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.	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. 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.
Overall Study STARTED	61	64
Overall Study Received Allocated Intervention:	51	56
Overall Study Completed Posttreatment Follow-up	50	55
Overall Study Completed 3-mo Follow-up	48	49
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	16	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Videoteleconferencing CPT n=61 Participants 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. Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.	Face-to-Face CPT n=64 Participants 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. 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.	Total n=125 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 11.8 • n=5 Participants	54.6 years STANDARD_DEVIATION 13.2 • n=7 Participants	55.3 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	64 Participants n=7 Participants	125 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	64 participants n=7 Participants	125 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Videoteleconferencing CPT n=61 Participants 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. Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.	Face-to-Face CPT n=64 Participants 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. 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.
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)	-15.97 units on a scale Standard Error 3.21	-11.22 units on a scale Standard Error 2.89

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Videoteleconferencing CPT n=61 Participants 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. Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.	Face-to-Face CPT n=64 Participants 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. 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.
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)	-14.22 units on a scale Standard Error 3.72	-9.46 units on a scale Standard Error 3.32

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Videoteleconferencing CPT n=61 Participants 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. Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.	Face-to-Face CPT n=64 Participants 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. 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.
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)	-15.17 units on a scale Standard Error 3.52	-9.61 units on a scale Standard Error 3.29

Adverse Events

Videoteleconferencing CPT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Face-to-Face CPT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leslie A. Morland, Clinical Psychologist

Department of Veterans Affairs

Phone: (619) 497-8406

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place