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Clinical Trials/NCT05199467
NCT05199467
Completed
Not Applicable

A Pilot Trial of Health Coaching to Improve Functioning and Reduce Suicide Risk Among Reintegrating Veterans

VA Office of Research and Development1 site in 1 country95 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Veteran Reintegration
Sponsor
VA Office of Research and Development
Enrollment
95
Locations
1
Primary Endpoint
Well-being Inventory - Functional Status
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
March 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Well-being Inventory - Functional Status

Time Frame: Month 9

The Functional Status composite measure from the Well-being Inventory scores range from 1 to 5, with higher scores indicating a higher level of functioning.

Depressive Symptom Index - Suicidality subscale

Time Frame: Month 9

The Suicidality subscale of the Depressive Symptom Index scores range from 0 to 12, with higher scores indicating higher suicidal ideation severity.

Columbia Suicide Severity Rating Scale

Time Frame: Month 9

The Columbia Suicide Severity Rating Scale - Screen scores range from 0 to 7, with higher scores indicating higher suicidal ideation severity.

Military to Civilian Questionnaire

Time Frame: Month 9

The Military to Civilian Questionnaire scores range from 0 to 4, with higher scores indicating a higher degree of reintegrating difficulty.

Secondary Outcomes

  • Number of VA healthcare visits (primary care, mental health, or other specialty care visits)(Month 9)

Study Sites (1)

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