Clinical trial NCT05199467: Health Coaching: A Pilot Trial Among Reintegrating Veterans
Official title: A Pilot Trial of Health Coaching to Improve Functioning and Reduce Suicide Risk Among Reintegrating Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Veteran Reintegration
Keywords: Veterans
Vocational rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Michigan
name: VA Finger Lakes Healthcare System
First posted: 2022-01-20
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Health coaches help people focus on goals, identify strengths and values, and work towards building the life they wish to live. Health coaching may be especially helpful for people navigating a life transition, such as Veterans who recently separated from military service (i.e., reintegrating Veterans). In this pilot trial the investigators will 1) examine the feasibility of study procedures and acceptability of health coaching among reintegrating Veterans, 2) evaluate measures for suitability in a future trial that will examine efficacy of the intervention, 3) determine barriers and facilitators to implementing the intervention among reintegrating Veterans.

Detailed description: This pilot study is designed to provide data to inform the design and procedures of a future efficacy trial of health coaching among reintegrating Veterans. An enrollment rate 30% and an assessment completion rate 65% at 9 months will be considered feasible enrollment and assessment completion rates for a future efficacy trial. An intervention completion rate 70% and mean score 27 on the Client Satisfaction Questionnaire-8 will indicate acceptability. Evaluation of measures will entail quantifying the mean levels in this population, characterizing typical variation in the outcomes, descriptive analyses of within-person change across time, and adjusted estimates of treatment effect sizes with 95% confidence intervals to calibrate the sample size needs of a fully powered trial. Qualitative interviews with participants will provide information on barriers and facilitators to implementation as well as perceived benefits and potential harms.

Eligibility criteria: Inclusion Criteria:

* United States military Veterans recently separated from service

Exclusion Criteria:

* Currently living in an institution (e.g., nursing home, prison)
* Cognitive impairment as indicated by a score equal to or greater than 10 on the Short Blessed Test
* Currently experiencing psychosis as indicated by endorsing thought interference or hallucinations on the Psychosis Screening Questionnaire
* At acute risk for suicide as indicated by the P4 screener
* Unable to read or understand English

Primary outcomes:
measure: Military to Civilian Questionnaire
timeFrame: Month 4
measure: Well-being Inventory - Functional Status
timeFrame: Month 4
measure: Military to Civilian Questionnaire
timeFrame: Month 9
measure: Well-being Inventory - Functional Status
timeFrame: Month 9
measure: Depressive Symptom Index - Suicidality subscale
timeFrame: Month 4
measure: Columbia Suicide Severity Rating Scale
timeFrame: Month 4
measure: Depressive Symptom Index - Suicidality subscale
timeFrame: Month 9
measure: Columbia Suicide Severity Rating Scale
timeFrame: Month 9
Secondary outcomes:
measure: Number of VA healthcare visits (primary care, mental health, or other specialty care visits)
timeFrame: Month 4
measure: Number of VA healthcare visits (primary care, mental health, or other specialty care visits)
timeFrame: Month 9
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Lauren M. Denneson, PhD
role: PRINCIPAL_INVESTIGATOR
References: