Clinical trial NCT04164667: Telehealth Pilot for Veterans with Chronic Multi-Symptom Illness.
Official title: Enhancing Executive Function and Self-regulation Success Through the Promotion of Brain Health Behaviors: a Telehealth Pilot Study for Veterans with Chronic Multi-symptom Illness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Multisymptom Illness
Keywords: Telehealth
Veterans
Exercise
Meditation
Health Coaching
Lead sponsor: War Related Illness and Injury Study Center
Sponsor class: FED
Collaborators: name: Georgetown University
name: Uniformed Services University of the Health Sciences
First posted: 2019-11-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this pilot study is to examine the feasibility, safety, and acceptability of a telehealth meditation and physical activity (MAP) intervention among Veterans with chronic multi-symptom illness.

Detailed description: This pilot study innovatively merges with ongoing clinical practice at the War Related Illness and Injury Study Center to explore the utility of new VA technologies and distance-bridging approaches for administering a remote intervention that promotes health behaviors (e.g., physical activity and meditation, called mental and physical training or MAP). Not only does this study intend to examine the feasibility of using these tools within the home setting and integrating these practices into the weekly lives of Veterans, but it also aims to determine the best way to administer this type of intervention by comparing a directed MAP (dMAP) intervention arm to a self-guided MAP (sgMAP) intervention arm. Understanding how much guidance to provide Veterans during their path towards recovery is important since we hope that this pilot study will offer not only evidence that these practices can be administered without supervision but also reveal that giving Veterans the right tools (exercise and meditation app on tablet), guidance (directed text message or holistic goals), and support (video-chat health coaching) can have measurable benefits on symptom severity and function.

Eligibility criteria: Inclusion Criteria:

* Previously deployed Veterans
* Experiencing Chronic Multisymptom Illness defined using the Fukuda criteria.
* Able to engage in physical activity
* Has a smart phone
* Co-enrolled in the WRIISC Data Repository Study

Exclusion Criteria:

* Excessive alcohol consumption (AUDIT Score \>= 4 (men); AUDIT Score \>= 3 (women))
* Current or previous drug use past 90 days.
* Current prominent suicide or homicidal ideation
* Recent exposure to trauma
* Acute or unstable illness
* Dementia or significant cognitive impairments

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 administering a telehealth MAP intervention
timeFrame: Through study completion, an average of 6 months
measure: Acceptability
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
measure: Patient Health Questionnaire- Depression scale (PHQ-9)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
measure: Posttraumatic Symptom Checklist - Military version (PCL-M)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
measure: Brief Symptom Inventory (BSI)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
measure: Five-Factor Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
measure: Medical Outcomes Study Short-Form-36 version 2 (SF-36v2)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
measure: Cognitive Difficulties Scale (CDS)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to Endpoint (2 months) and baseline to 5 months.
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Washington DC Veteran's Affair Medical Center
state: District of Columbia
Study officials:
affiliation: DC WRIISC Director
name: Matthew Reinhard, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: DC WRIIISC Research Director
name: Michelle Costanzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: