| ID | Type | Description | Link |
|---|---|---|---|
| 2008-05_LM_Promise 0005 | Other Identifier | VAPHICS IRB | |
| PT074516 | Other Grant/Funding Number | CDMRP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Videoteleconferencing CPT | Experimental | 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. |
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| Face-to-Face CPT | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy Group Videoteleconference | Behavioral | Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-treatment (two-weeks following end of treatment) |
| 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. | 3-month Post-treatment |
| 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. | 6 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie A Morland, PsyD | VA Pacific Islands Health Care System, Honolulu, HI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pacific Islands Health Care System, Honolulu, HI | Honolulu | Hawaii | 96819-1522 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19576299 | Result | 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. | |
| 21793047 | Result | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cognitive Processing Therapy Group In-Person | Behavioral | Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference. |
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| 24922484 | Result | 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. |
| 32077948 | Derived | 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. |
| 26745686 | Derived | 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. |
| 26466310 | Derived | 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. |
| FG001 | 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. |
| Received Allocated Intervention: |
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| Completed Posttreatment Follow-up |
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| Completed 3-mo Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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Male combat veterans with posttraumatic stress disorder (PTSD).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Posted | Mean | Standard Error | units on a scale | Post-treatment (two-weeks following end of treatment) |
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| 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. | Posted | Mean | Standard Error | units on a scale | 3-month Post-treatment |
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| 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. | Posted | Mean | Standard Error | units on a scale | 6 months post-treatment |
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The study was monitored for adverse events from 2009 to 2013.
At the onset of study a committee was established among the investigators that guided protocol monitoring of any unanticipated problems involving risk to participants or others (UPRs) (which includes serious adverse events) that could occur in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 61 | 0 | 61 | ||
| EG001 | 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. | 0 | 64 | 0 | 64 |
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For patients in rural areas, their local mental health facilities may not have access to videoteleconferencing technology.There were no women veterans as study participants. Participants with acute safety concerns or current substances were excluded.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie A. Morland, Clinical Psychologist | Department of Veterans Affairs | (619) 497-8406 | leslie.morland@va.gov |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Yes |
| Non-Inferiority or Equivalence |
We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points). |
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