Posttraumatic Stress DisorderPhase 3CPTVTELNCT00879255
Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With Posttraumatic Stress Disorder
A Phase 3 study testing Cognitive Processing Therapy Group Videoteleconference and Cognitive Processing Therapy Group In-Person in people with Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Cognitive Processing Therapy Group Videoteleconference and Cognitive Processing Therapy Group In-Person
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pacific Islands Health Care System, Honolulu, HI
Honolulu, Hawaii, 96819-1522
About this study
Official title: Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With PTSD
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Cognitive Processing Therapy Group Videoteleconference, Cognitive Processing Therapy Group In-Person
- Keywords
- cognitive processing therapy, combat, veterans, PTSD, Telemental Health, Videoteleconference, outcome, Rural, Remote, CPT, VTC
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy Group VideoteleconferenceBehavioural
Also called CPT-VT
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.
Cognitive Processing Therapy Group In-PersonBehavioural
Also called CPT-NP
Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Processing Therapy Group Videoteleconference |
| 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. Receives: Behavioral: Cognitive Processing Therapy Group In-Person |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Leslie A Morland, PsyD, Principal investigator, VA Pacific Islands Health Care System, Honolulu, HI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879255
- Sponsor's protocol ID
- DHI 07-259
- Other IDs
- 2008-05_LM_Promise 0005, PT074516
- Acronym
- CPTVTEL
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2009
- Last updated
- 12 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19576299Morland 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.
PubMed 21793047Morland 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.
PubMed 24922484Glassman 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.
PubMed 32077948Raab 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.
PubMed 26745686Raab 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.
PubMed 26466310
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemental Health and Cognitive Processing Therapy for Rural Combat Veterans With PTSD
- ClinicalTrials.gov ID
- NCT00879255
- Acronym / sponsor ID
- CPTVTEL / DHI 07-259
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- cognitive processing therapy, combat, veterans, PTSD, Telemental Health, Videoteleconference, outcome, Rural
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videoteleconferencing CPT | Experimental | Behavioral: Cognitive Processing Therapy Group VideoteleconferenceThe 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. |
| Face-to-Face CPT | Active comparator | Behavioral: Cognitive Processing Therapy Group In-PersonThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing Therapy Group VideoteleconferenceAlso: CPT-VTCognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference. | Behavioural | Videoteleconferencing CPT |
| Cognitive Processing Therapy Group In-PersonAlso: CPT-NPCognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference. | Behavioural | Face-to-Face CPT |
Primary outcome
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
Time frame: 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.
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
Time frame: 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.
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19576299Morland 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 publication: PubMed 21793047Morland 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 publication: PubMed 24922484Morland 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.
- Derived from this study: PubMed 32077948Glassman 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.
- Derived from this study: PubMed 26745686Raab 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.
- Derived from this study: PubMed 26466310Raab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie A Morland, PsyD principal investigator
VA Pacific Islands Health Care System, Honolulu, HI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Processing Therapy Group Videoteleconference and Cognitive Processing Therapy Group In-Person in people with Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale, for DSM-IV (CAPS IV) (time frame: Post-treatment (two-weeks following end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00879255, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.