Health Coaching: A Pilot Trial Among Reintegrating Veterans

NCT ID: NCT05199467

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Veteran Reintegration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Health Coaching

Receipt of up to 12 sessions of health coaching, plus printed materials providing information on VA benefits

Group Type EXPERIMENTAL

Health Coaching

Intervention Type BEHAVIORAL

Health coaches help people focus on goals, identify strengths and values, and work towards building the kind of life they wish to live.

VA Benefits Information

Intervention Type BEHAVIORAL

Printed materials with information on VA benefits.

VA Benefits Information

Receipt of printed materials providing information on VA benefits

Group Type ACTIVE_COMPARATOR

VA Benefits Information

Intervention Type BEHAVIORAL

Printed materials with information on VA benefits.

Interventions

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Health Coaching

Health coaches help people focus on goals, identify strengths and values, and work towards building the kind of life they wish to live.

Intervention Type BEHAVIORAL

VA Benefits Information

Printed materials with information on VA benefits.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

VA Finger Lakes Healthcare System

UNKNOWN

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren M. Denneson, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Portland Health Care System, Portland, OR

Locations

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VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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D3704-R

Identifier Type: -

Identifier Source: org_study_id

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