NCT03364192

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 21, 2020

Completed
Last Updated

December 21, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

November 30, 2017

Results QC Date

October 30, 2020

Last Update Submit

November 23, 2020

Conditions

Keywords

Whole Health CoachingIntegrative Health CoachingPeer Support SpecialistPersonalized Health Plan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • PTSD Checklist for DSM-5 (PCL-5)

    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.

  • Inventory of Psychosocial Functioning (IPF)

    Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.

  • Client Satisfaction Questionnaire

    8 weeks following intervention onset

Study Arms (1)

Peer-delivered Whole Health Coaching

EXPERIMENTAL

Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it will be administered by a peer support specialist.

Behavioral: Whole Health Coaching

Interventions

Veterans Health Administration variation of integrative health coaching.

Peer-delivered Whole Health Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Emily M. Johnson, Ph.D., PI
Organization
VA Center for Integrated Healthcare

Study Officials

  • Emily Johnson, PhD

    Syracuse VA Medical Center, Syracuse, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: All participants will receive peer-delivered Whole Health Coaching but the start date will be randomized between 4 and 13 weeks from initiation of the study.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

May 1, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

December 21, 2020

Results First Posted

December 21, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations