Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02685358
Other study ID # IIR 14-288
Secondary ID HX-001790-1
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date September 30, 2021

Study information

Verified date February 2024
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 234
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Behavioral:
Clinician-Supported PTSD Coach
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 Usual
Existing primary care mental health integrated treatment will serve as the comparison condition

Locations

Country Name City State
United States VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California
United States Syracuse VA Medical Center, Syracuse, NY Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. 16 and 24 weeks
Secondary 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. Baseline, 8 week, 16 week, 24 week
Secondary 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. 8 week
Secondary 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. Baseline, 8 week, 16 week, 24 week
Secondary 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. Baseline, 8 week, 16 week, 24 week
Secondary 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. Baseline, 8 week, 16 week, 24 week
See also
  Status Clinical Trial Phase
Completed NCT03384706 - A Comparison of CPT Versus ART Versus WL N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT05113277 - Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Completed NCT00644423 - Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD) N/A
Completed NCT02989987 - NET for SGBV Survivors in Eastern DR Congo N/A
Completed NCT02320799 - Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya N/A
Recruiting NCT02293291 - Thermal Clinic Treatment in Gulf War Illness Phase 1/Phase 2
Completed NCT02242136 - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants N/A
Completed NCT02720497 - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01693978 - Contingency Outcomes in Prolonged Exposure N/A
Completed NCT01469754 - Longitudinal Survey Analysis in Lymphoma Survivors N/A
Completed NCT02362477 - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD Phase 3
Terminated NCT01239173 - Emotional Memory Reactivation in Posttraumatic Stress Disorder Phase 3