Posttraumatic Stress DisorderNCT02685358
An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
A study testing Clinician-Supported PTSD Coach and Primary Care Mental Health Integrated Care as Usual in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Clinician-Supported PTSD Coach and Primary Care Mental Health Integrated Care as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2017to 30 Sep 2021
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans enrolled in primary care within the VA Syracuse and Palo Alto healthcare systems reporting 33 on the PTSD Checklist-5 (PCL-5) and a traumatic event on the Criterion A screener
Who cannot join
- Patients will be excluded if they demonstrate symptoms that would not allow them to actively engage in the CS PTSD Coach, i.e.,
- gross cognitive impairment
- Current symptoms of mania or psychosis or who have more pressing concerns that need to be addressed first, i.e.,
- suicide attempt in the last two months or current intent to commit suicide
- Patients with recent suicide attempts or intent are eligible to be enrolled follow the receipt of suicide prevention services
- The investigators will also exclude patients that are already receiving psychotherapy or MH counseling for PTSD outside of PC
- Started or changed the dose of a psychotropic medication for PTSD in the last two months that was prescribed outside of VA PC
- Voice a preference to be directly referred to MH specialty care
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210
About this study
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project seeks to improve health care for Veterans by testing the effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. If this treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project represents a unique opportunity to improve health care for Veterans by examining the effectiveness of a primary care-based treatment called Clinician-Supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. This randomized clinical trial will enroll and treat 260 VA primary care patients (female and male) who have PTSD and are not currently being treated for it. Commonly used, well-established clinical interviews and self-report measures will be used to assess important clinical outcomes. If this direct treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Clinician-Supported PTSD Coach, Primary Care Mental Health Integrated Care as Usual
- Keywords
- Stress Disorders, Post-traumatic, Primary Health Care, Mobile Applications, Veterans
- 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.
Clinician-Supported PTSD CoachBehavioural
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
Primary Care Mental Health Integrated Care as UsualBehavioural
Existing primary care mental health integrated treatment will serve as the comparison condition
| Study group | Role | What they receive |
|---|---|---|
| Clinician-Supported PTSD Coach | Experimental | Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks. Receives: Behavioral: Clinician-Supported PTSD Coach |
| Primary Care Mental Health Integrated Care as Usual | Active comparator | Existing primary care mental health integrated treatment will serve as the comparison condition Receives: Behavioral: Primary Care Mental Health Integrated Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.
Measured: Baseline
Hospital Administrative Data Showing 2 Mental Health Visits Completed
Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period.
Measured: 16 and 24 weeks
Secondary outcomes (5)
PTSD Checklist-5 (PCL-5)
The PCL-5 is a 20-item self-report measure assessing how much respondents have been bothered by DSM-5 PTSD symptoms in the past month. Scores can range from 0 to 80 with higher scores reflecting worse PTSD symptom severity.
Measured: Baseline, 8 week, 16 week, 24 week
Client Satisfaction Questionnaire (CSQ)
The CSQ is a widely used 8-item self-report measure assessing patient satisfaction with care. Scores can range from 8 to 32 with higher scores reflecting greater satisfaction.
Measured: 8 week
Patient Health Questionnaire (PHQ-9)
A 9-item self-report instrument used to assess depression severity. Items are scored 0 to 3, with the total score being the sum of the 9 items which can range from 0 as the minimum value to 27 as the maximum value. Higher scores indicate greater depression severity, with a score of 10 or greater indicating probable major depression, and scores of 20 or more severe major depression.
Measured: Baseline, 8 week, 16 week, 24 week
WHOQOL-BREF Psychological Health Subscale
The psychological health (6 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-30 with higher scores reflecting better quality of life.
Measured: Baseline, 8 week, 16 week, 24 week
WHOQOL-BREF Social Relationships Subscale
The social relationships (3 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-15 with higher scores reflecting better quality of life.
Measured: Baseline, 8 week, 16 week, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start1 Mar 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinician-Supported PTSD Coach (CS PTSD Coach) consists of four 20-30 minute sessions focused on instructions for using the PTSD Coach app, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for completion between sessions. PC-MHI providers deliver CS PTSD Coach using a treatment manual, which was developed and piloted by the PIs. Session 1 will be face-to-face and sessions 2-4 may be face-to-face or by phone, depending on patient preference. To help participants overcome treatment barriers psycho-education about treatment options are provided and active problems solving is encouraged. Specific next steps for treatment or self-management are developed collaboratively, typically in session 4. After session 4, Participants are encouraged to continue using PTSD Coach and have access to the research version of the app until the 24-week follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric R Kuhn, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685358
- Sponsor's protocol ID
- IIR 14-288
- Other IDs
- HX-001790-1
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2016
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Possemato K, Johnson E, Barrie K, Ghaus S, Noronha D, Wade M, Greenbaum MA, Rosen C, Cloitre M, Owen J, Jain S, Beehler G, Prins A, Seal K, Kuhn E. A Randomized Clinical Trial of Clinician-Supported PTSD Coach in VA Primary Care Patients. J Gen Intern Med. 2023 Jul;38(Suppl 3):905-912. doi: 10.1007/s11606-023-08130-6. Epub 2023 Mar 17.
PubMed 36932268
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
- ClinicalTrials.gov ID
- NCT02685358
- Acronym / sponsor ID
- IIR 14-288
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Stress Disorders, Post-traumatic, Primary Health Care, Mobile Applications, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project seeks to improve health care for Veterans by testing the effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. If this treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
Detailed description
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project represents a unique opportunity to improve health care for Veterans by examining the effectiveness of a primary care-based treatment called Clinician-Supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. This randomized clinical trial will enroll and treat 260 VA primary care patients (female and male) who have PTSD and are not currently being treated for it. Commonly used, well-established clinical interviews and self-report measures will be used to assess important clinical outcomes. If this direct treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Clinician-Supported PTSD Coach (CS PTSD Coach) consists of four 20-30 minute sessions focused on instructions for using the PTSD Coach app, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for completion between sessions. PC-MHI providers deliver CS PTSD Coach using a treatment manual, which was developed and piloted by the PIs. Session 1 will be face-to-face and sessions 2-4 may be face-to-face or by phone, depending on patient preference. To help participants overcome treatment barriers psycho-education about treatment options are provided and active problems solving is encouraged. Specific next steps for treatment or self-management are developed collaboratively, typically in session 4. After session 4, Participants are encouraged to continue using PTSD Coach and have access to the research version of the app until the 24-week follow-up.
| Arm | Type | Receives |
|---|---|---|
| Clinician-Supported PTSD Coach | Experimental | Behavioral: Clinician-Supported PTSD CoachClinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks. |
| Primary Care Mental Health Integrated Care as Usual | Active comparator | Behavioral: Primary Care Mental Health Integrated Care as UsualExisting primary care mental health integrated treatment will serve as the comparison condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans enrolled in primary care within the VA Syracuse and Palo Alto healthcare systems reporting 33 on the PTSD Checklist-5 (PCL-5) and a traumatic event on the Criterion A screener
Key exclusion criteria (8 listed)
- Patients will be excluded if they demonstrate symptoms that would not allow them to actively engage in the CS PTSD Coach, i.e.,
- Current symptoms of mania or psychosis or who have more pressing concerns that need to be addressed first, i.e.,
- Patients with recent suicide attempts or intent are eligible to be enrolled follow the receipt of suicide prevention services
- The investigators will also exclude patients that are already receiving psychotherapy or MH counseling for PTSD outside of PC
- Started or changed the dose of a psychotropic medication for PTSD in the last two months that was prescribed outside of VA PC
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 |
|---|---|---|
| Clinician-Supported PTSD CoachClinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks. | Behavioural | Clinician-Supported PTSD Coach |
| Primary Care Mental Health Integrated Care as UsualExisting primary care mental health integrated treatment will serve as the comparison condition | Behavioural | Primary Care Mental Health Integrated Care as Usual |
Primary outcome
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Baseline
The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.
Hospital Administrative Data Showing 2 Mental Health Visits Completed
Time frame: 16 and 24 weeks
Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period.
5 secondary outcomes
PTSD Checklist-5 (PCL-5)
Time frame: Baseline, 8 week, 16 week, 24 week
Client Satisfaction Questionnaire (CSQ)
Time frame: 8 week
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 8 week, 16 week, 24 week
WHOQOL-BREF Psychological Health Subscale
Time frame: Baseline, 8 week, 16 week, 24 week
WHOQOL-BREF Social Relationships Subscale
Time frame: Baseline, 8 week, 16 week, 24 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36932268Possemato K, Johnson E, Barrie K, Ghaus S, Noronha D, Wade M, Greenbaum MA, Rosen C, Cloitre M, Owen J, Jain S, Beehler G, Prins A, Seal K, Kuhn E. A Randomized Clinical Trial of Clinician-Supported PTSD Coach in VA Primary Care Patients. J Gen Intern Med. 2023 Jul;38(Suppl 3):905-912. doi: 10.1007/s11606-023-08130-6. Epub 2023 Mar 17.
- Individual participant dataSharing planned: No
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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.
Eric R Kuhn, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician-Supported PTSD Coach and Primary Care Mental Health Integrated Care as Usual in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 2 sites 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 1 inclusion and 8 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). 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-5 (CAPS-5) (time frame: Baseline). The study lists 2 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 NCT02685358, which also lists 1 linked publication.
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 4 Mar 2024.