PTSD Clinical Trial
Official title:
Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans With PTSD
NCT number | NCT03364192 |
Other study ID # | D2476-M |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | October 31, 2019 |
Verified date | November 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are evaluating a service called peer-delivered Whole Health Coaching to understand how it can help Veterans with PTSD. This project has two main goals: (1) determine how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress disorder and (2) learning about feasibility of implementing this service in Veterans Health Administration primary care settings. The investigators are also evaluating feasibility of the research methods in this trial to learn how to improve future studies on this topic. Whole Health Coaching is a service designed to improve health and wellness. It is a variation of integrative health coaching and is being used in Veterans Health Administration medical centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal health mission, develop specific goals and action steps, and then adjust their plan as needed. Coaches provide guidance and support throughout the process. In this project, a peer support specialist working in primary care will be the coach. VA Peer Support Specialists, "peers", are Veterans recovering from a mental health condition trained to help other Veterans improve their health. All participants will receive peer-delivered Whole Health Coaching. Participants will be randomly assigned a start date for their first session with the Peer Whole Health Coach between 4 and 13 weeks after they start the study. The information provided during this time prior to the first session helps us understand how participants do on their own without the service. The research components include interviews and questionnaires about health and wellness, goals, and experiences with the service. Veterans who participate in the study will complete short questionnaires twice a week for 6 months and have four longer appointments where more questions will be asked. Participants will also be given the opportunity to provide feedback on the service.
Status | Completed |
Enrollment | 28 |
Est. completion date | October 31, 2019 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Veteran status - Enrolled in primary care at the Syracuse VA (and affiliated CBOCs) and seen in primary care within the past year - Probable PTSD defined as screening positive for a Criterion A event and PTSD Checklist for DSM-5 (PCL-5) score 33 Exclusion Criteria: - Unable to communicate in spoken and written English - Gross cognitive impairment - Current symptoms of mania/psychosis - At risk for suicide - Engaged in psychotherapy in a non-primary care setting - Changes to psychotropic medications for PTSD within the last 2 months - Preference for direct referral to specialty mental healthcare |
Country | Name | City | State |
---|---|---|---|
United States | Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | US Department of Veterans Affairs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Goal Attainment Scaling (GAS) | Goal Attainment Scaling (GAS) is a systematic method used to evaluate participants' individualized goals and progress towards Whole Health goals. Scores range from 0-10 for each domain of whole health measured with higher scores indicating more positive outcomes. Each participant's GAS score reflects the GAS score from the goal domain(s) that the participant identified as primary during the course of the intervention. For participants with multiple goals, GAS scores were average across domains. | Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time. | |
Secondary | PTSD Checklist for DSM-5 (PCL-5) | The PTSD Checklist for DSM-5 (PCL-5) is a measure of participants' PTSD symptoms. The total sum score ranges from 0-80 with lower scores indicating more positive outcomes. | Participants completed the PCL-5 at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period. | |
Secondary | Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is a measure of psychosocial functioning across several domains. The total score was used for this project and reflects a composite of multiple subscales (romantic relationships, family, work, friendships and socializing, parenting, education, and self care). Scores range from 0-100 with lower scores indicating more positive outcomes. | Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period. | |
Secondary | Client Satisfaction Questionnaire | Measure of participants' satisfaction with the peer-delivered Whole Health Coaching service. CSQ-8 scores range from 8-32 with higher values indicating more positive outcomes. | 8 weeks following intervention onset |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03962504 -
Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
|
N/A | |
Completed |
NCT01995123 -
Behavioral Activation for Smoking Cessation in PTSD
|
N/A | |
Not yet recruiting |
NCT06278922 -
Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma
|
N/A | |
Completed |
NCT04597450 -
Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)
|
Phase 1 | |
Completed |
NCT03593772 -
Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD
|
N/A | |
Completed |
NCT03429166 -
Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
|
N/A | |
Recruiting |
NCT04317820 -
Deep Brain Reorienting in Post-traumatic Stress Disorder
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT03504722 -
Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD
|
N/A | |
Completed |
NCT04305353 -
Intensive Care Unit (ICU) Diary Project
|
N/A | |
Completed |
NCT03113890 -
McLean and Genomind Prospective Study
|
N/A | |
Withdrawn |
NCT05173831 -
Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
|
Phase 2 | |
Not yet recruiting |
NCT04056767 -
Changes in Digital Phenotype During PE Therapy
|
||
Withdrawn |
NCT03924297 -
Chilipad for Sleep and Symptoms of PTSD
|
N/A | |
Completed |
NCT03343028 -
Biomarker Establishment for Superior Treatment of PTSD
|
||
Withdrawn |
NCT03216356 -
Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD
|
Phase 2/Phase 3 | |
Completed |
NCT03158558 -
Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD
|
N/A | |
Completed |
NCT02370173 -
A Non-Pharmacological Method for Enhancing Sleep in PTSD
|
N/A | |
Completed |
NCT01955538 -
The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees.
|
Phase 3 | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A |