Posttraumatic Stress Disorder
Conditions
Keywords
cognitive processing therapy, combat, veterans, PTSD, Telemental Health, Videoteleconference, outcome, Rural, Remote, CPT, VTC
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.
Interventions
BEHAVIORALCognitive Processing Therapy Group Videoteleconference
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
BEHAVIORALCognitive 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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 64 |
| Total | 125 |
Baseline characteristics
| Characteristic | Videoteleconferencing CPT | Face-to-Face CPT | Total |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 11.8 | 54.6 years STANDARD_DEVIATION 13.2 | 55.3 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment United States | 61 participants | 64 participants | 125 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 61 Participants | 64 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 64 |
| serious Total, serious adverse events | 0 / 61 | 0 / 64 |
Outcome results
Primary
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.
Time frame: Post-treatment (two-weeks following end of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing CPT | Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -15.97 units on a scale | Standard Error 3.21 |
| Face-to-Face CPT | Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -11.22 units on a scale | Standard Error 2.89 |
p-value: >0.0595% CI: [-11.92, 2.42]noninferiority analysis
Primary
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.
Time frame: 3-month Post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing CPT | Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -14.22 units on a scale | Standard Error 3.72 |
| Face-to-Face CPT | Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -9.46 units on a scale | Standard Error 3.32 |
p-value: >0.0595% CI: [-11.65, 2.13]noninferiority design
Primary
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.
Time frame: 6 months post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing CPT | Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -15.17 units on a scale | Standard Error 3.52 |
| Face-to-Face CPT | Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) | -9.61 units on a scale | Standard Error 3.29 |
p-value: >0.0595% CI: [-16.26, 5.14]noninferiority test