Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2020
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Whole Health Coaching
Veterans Health Administration variation of integrative health coaching.

Locations

Country Name City State
United States Syracuse VA Medical Center, Syracuse, NY Syracuse New York

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  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