Clinical trial NCT06711172: Assessing the Feasibility of a Whole Health Coaching Intervention for Veterans With Chronic Multisymptom Illness
Official title: Assessing the Feasibility of a Whole Health Coaching Intervention for Veterans With Chronic Multisymptom Illness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Multisymptom Illness
Keywords: Health coaching, chronic multisymptom illness
Lead sponsor: War Related Illness and Injury Study Center
Sponsor class: FED
First posted: 2024-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (recruitment rate)
timeFrame: Through study completion, an average of 6 months
measure: Feasibility (retention rate)
timeFrame: Through study completion, an average of 6 months
measure: Feasibility (adherence rate)
timeFrame: Through study completion, an average of 6 months
measure: Safety of a health coaching intervention
timeFrame: Through study completion, an average of 6 months
measure: Acceptability
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: RAND 36-Item Health Survey (SF-36)
timeFrame: Baseline to 3 months and baseline to 6 months
measure: Personal Health Inventory (PHI)
timeFrame: Baseline to 3m and baseline to 6m
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to 6 months
measure: Generalized Anxiety Disorder scale (GAD-7)
timeFrame: Baseline to 6 months
measure: VA Pain Numeric Pain Rating Score
timeFrame: Baseline to 6 months
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline to 6 months
measure: Patient Health Questionnaire-8 (PHQ8)
timeFrame: Baseline to 6 month
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington, DC Veterans Affairs Medical Center
state: District of Columbia
Study officials:
affiliation: War Related Illness and Injury Study Center
name: Rebecca McCullers, RN, NBC-HWC
role: PRINCIPAL_INVESTIGATOR
References: