NCT05199467

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

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

December 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

December 10, 2021

Last Update Submit

April 3, 2025

Conditions

Keywords

VeteransVocational rehabilitation

Outcome Measures

Primary Outcomes (8)

  • Military to Civilian Questionnaire

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

    Month 4

  • Well-being Inventory - Functional Status

    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.

    Month 4

  • Military to Civilian Questionnaire

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

    Month 9

  • Well-being Inventory - Functional Status

    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.

    Month 9

  • Depressive Symptom Index - Suicidality subscale

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

    Month 4

  • Columbia Suicide Severity Rating Scale

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

    Month 4

  • Depressive Symptom Index - Suicidality subscale

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

    Month 9

  • Columbia Suicide Severity Rating Scale

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

    Month 9

Secondary Outcomes (2)

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

    Month 4

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

    Month 9

Study Arms (2)

Health Coaching

EXPERIMENTAL

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

Behavioral: Health CoachingBehavioral: VA Benefits Information

VA Benefits Information

ACTIVE COMPARATOR

Receipt of printed materials providing information on VA benefits

Behavioral: VA Benefits Information

Interventions

Health CoachingBEHAVIORAL

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

Health Coaching

Printed materials with information on VA benefits.

Health CoachingVA Benefits Information

Eligibility Criteria

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

You may qualify if:

  • United States military Veterans recently separated from service

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

Study Officials

  • Lauren M. Denneson, PhD

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2021

First Posted

January 20, 2022

Study Start

November 1, 2022

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations