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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| VA Finger Lakes Healthcare System | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Coaching | Experimental | Receipt of up to 12 sessions of health coaching, plus printed materials providing information on VA benefits |
|
| VA Benefits Information | Active Comparator | Receipt of printed materials providing information on VA benefits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Coaching | Behavioral | Health coaches help people focus on goals, identify strengths and values, and work towards building the kind of life they wish to live. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Depressive Symptom Index - Suicidality Subscale | Reported as count of participants with no suicidal ideation | Month 4 |
| Columbia Suicide Severity Rating Scale | Reported as count of participants with no suicidal ideation | Month 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren M. Denneson, PhD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97207-2964 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42007499 | Derived | Denneson LM, Goldstick JE, Kemp KM, O'Shea B, Chen JI, Pfeiffer PN, Carlson KF, Britton PC. A Randomized Controlled Pilot Trial of Health Coaching to Improve Functioning and Reduce Suicidal Ideation Among Veterans Reintegrating Into Civilian Life. Suicide Life Threat Behav. 2026 Apr;56(2):e70097. doi: 10.1111/sltb.70097. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Coaching | Received health coaching |
| FG001 | Enhanced Current Reintegration Services | Received current reintegration services with enhancement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Coaching | Received health coaching |
| BG001 | Enhanced Current Reintegration Services | Received current reintegration services with enhancement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis included participants who completed the month 4 questionnaire | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
|
From enrollment up to end of 9 month follow up questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Health Coaching | Received health coaching | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal investigator | VA Portland Health Care System | 503-220-8262 | lauren.denneson@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2025 | Apr 7, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2023 | Jul 25, 2024 | ICF_000.pdf |
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| VA Benefits Information | Behavioral | Printed materials with information on VA benefits. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Military to Civilian Questionnaire | Scores range from 0 to 4, with higher scores indicating a higher degree of reintegrating difficulty. | Mean | Standard Deviation | score on a scale |
|
| Well-being Inventory | Scores range from 1 to 5, with higher scores indicating a higher level of functioning. | Mean | Standard Deviation | score on a scale |
|
| Depressive Symptom Index - Suicidality Subscale | Reported as count of participants with no suicidal ideation | Count of Participants | Participants |
|
| Columbia Suicide Severity Rating Scale | Reported as count of participants with no suicidal ideation | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Analysis included participants who completed the month 4 questionnaire | Posted | Mean | Standard Deviation | score on a scale | Month 4 |
|
|
|
| Primary | Depressive Symptom Index - Suicidality Subscale | Reported as count of participants with no suicidal ideation | Analysis included participants who completed the month 4 questionnaire | Posted | Count of Participants | Participants | Month 4 |
|
|
|
| Primary | Columbia Suicide Severity Rating Scale | Reported as count of participants with no suicidal ideation | Analysis included participants who completed the month 4 questionnaire | Posted | Count of Participants | Participants | Month 4 |
|
|
|
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Enhanced Current Reintegration Services | Received current reintegration services with enhancement | 0 | 47 | 0 | 47 | 0 | 47 |
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