Assessing the Feasibility of a Whole Health Coaching Intervention for Veterans With Chronic Multisymptom Illness

Not Applicable

Active, not recruiting

• Conditions: Chronic Multisymptom Illness

• Registration Number: NCT06711172
• Lead Sponsor: War Related Illness and Injury Study Center

Brief Summary

This study examines the impact of a clinical whole health coaching program aimed at improving Veteran's health and well-being by promoting engagement/adherence with clinical recommendations and increasing healthy lifestyle behaviors in treatment-seeking Veterans receiving care at the DC and CA War Related Illness and Injury Study Centers.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-29
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Veterans receiving a clinical evaluation at the War Related Illness and Injury Study Centers in Washington, DC or Palo Alto, California.

Exclusion Criteria

• Current active suicidal or homicidal ideation
• Current or lifetime history of a psychiatric disorder with primary psychotic features
• Current or lifetime bipolar disorder
• Acute or unstable psychiatric condition(s) and/or chronic illnesses that would benefit from immediate referral for treatment
• Neurological disorders such as Alzheimer's disease, advanced Parkinson's disease, and unstable epilepsy
• Pregnancy
• Current exposure to trauma, or exposure to trauma in the past 3 months
• Current or within the past 30 days substance abuse or dependence (except nicotine)
• Excessive alcohol intake defined as an AUDIT score ≥ 4 for men and an AUDIT score ≥ 3 for women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility (recruitment rate)	Through study completion, an average of 6 months	Calculated as the number of participants who consented into the study divided by the number of participants who were approached for study participation.
Feasibility (retention rate)	Through study completion, an average of 6 months	Calculated as a percentage for each time point (3 months and 6 months).
Feasibility (adherence rate)	Through study completion, an average of 6 months	Calculated as the number of health coaching sessions completed out of 17 total sessions.
Safety of a health coaching intervention	Through study completion, an average of 6 months	Reported as the number of adverse events self-reported by participants during the intervention
Acceptability	Through study completion, an average of 6 months	Acceptability was evaluated qualitatively using feedback captured during health coaching sessions.

Secondary Outcome Measures

Name	Time	Method
VA Pain Numeric Pain Rating Score	Baseline to 6 months	To assess pain levels
Five Facet Mindfulness Questionnaire (FFMQ)	Baseline to 6 months	To evaluate mindfulness
Patient Health Questionnaire-8 (PHQ8)	Baseline to 6 month	To assess the level of depression symptoms
RAND 36-Item Health Survey (SF-36)	Baseline to 3 months and baseline to 6 months	To measure physical and mental health-related quality of life.
Personal Health Inventory (PHI)	Baseline to 3m and baseline to 6m	The PHI is a 15-item, self-assessment questionnaire that assesses the eight self-care areas identified in the VA's Whole Health, "Circle of Health."
Pittsburgh Sleep Quality Index (PSQI)	Baseline to 6 months	To assess sleep quality and sleep disturbances
Generalized Anxiety Disorder scale (GAD-7)	Baseline to 6 months	To assess the level of anxiety symptoms

Trial Locations

Locations (1)

Washington, DC Veterans Affairs Medical Center; 🇺🇸 Washington, District of Columbia, United States