Telehealth Pilot for Veterans with Chronic Multi-Symptom Illness.
- Conditions
- Chronic Multisymptom Illness
- Interventions
- Behavioral: Self-guided practice of the combined intervention of physical activity and mindfulness meditationBehavioral: Directed instruction of the combined intervention of physical activity and mindfulness meditation
- Registration Number
- NCT04164667
- Lead Sponsor
- War Related Illness and Injury Study Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-Guided Self-guided practice of the combined intervention of physical activity and mindfulness meditation Participant's do not receive text message direction from the VA Annie Text Messaging System. Participant's create their own method for accomplishing app-based exercise and mindfulness practice without detailed instructions. Directed Messaging Directed instruction of the combined intervention of physical activity and mindfulness meditation Participant's receive text message directions from the ANNIE VA messaging system. The directed messaging system provides text message details of the participant's app-based meditation and exercise instructions.
- Primary Outcome Measures
Name Time Method Safety of administering a telehealth MAP intervention Through study completion, an average of 6 months Number of adverse events reported during the intervention
Feasibility (Recruitment rate) Through study completion, an average of 6 months Recruitment rate was calculated as the number of participants who consented into the study divided by the number of eligible WRIISC patients who were approached during enrollment.
Feasibility (Retention rate) Through study completion, an average of 6 months Retention rate was calculated for each time point (endpoint and 3m follow-up) and reported as a percentage.
Feasibility (Adherence rate) Through study completion, an average of 6 months Due to the multiple components of the intervention, adherence rates were calculated for the meditation and exercise components separately and overall adherence to the MAP training protocol.
Acceptability Through study completion, an average of 6 months Acceptability was quantified using the qualitative feedback provided by participants during their health coaching sessions.
- Secondary Outcome Measures
Name Time Method Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Baseline to Endpoint (2 months) and baseline to 5 months. The BRIEF-A was used to assess executive function across nine overlapping domains: Emotional Control, Initiate, Inhibit, Organization of Materials, Plan/Organize, Self-Monitor, Shift, Task Monitor, and Working Memory. In addition, the Global Executive Composite score and two summary index scores (Behavioral Regulation Index and Metacognition Index) were calculated. Higher scores are indicative of greater difficulty.
Patient Health Questionnaire- Depression scale (PHQ-9) Baseline to Endpoint (2 months) and baseline to 5 months. The PHQ-9 was used to assess the severity of depression symptoms. Higher scores are indicative of greater depression symptoms.
Posttraumatic Symptom Checklist - Military version (PCL-M) Baseline to Endpoint (2 months) and baseline to 5 months. To evaluate the severity of PTSD symptoms in an individual who has had military experience. Higher scores are indicative of greater PTSD symptoms.
Perceived Stress Scale (PSS) Baseline to Endpoint (2 months) and baseline to 5 months. To measure the perception of stress
Brief Symptom Inventory (BSI) Baseline to Endpoint (2 months) and baseline to 5 months. To evaluate the degree of psychological distress.
Five-Factor Mindfulness Questionnaire (FFMQ) Baseline to Endpoint (2 months) and baseline to 5 months. To evaluate mindfulness across five domains: Awareness, Describing, Non-judging of Inner Experience, Non-reactivity to Inner Experience, and Observing.
Medical Outcomes Study Short-Form-36 version 2 (SF-36v2) Baseline to Endpoint (2 months) and baseline to 5 months. To assess quality of life (physical and mental).
Cognitive Difficulties Scale (CDS) Baseline to Endpoint (2 months) and baseline to 5 months. To assess cognitive complaints.
Pittsburgh Sleep Quality Index (PSQI) Baseline to Endpoint (2 months) and baseline to 5 months. To measure the quality and patterns of sleep in adults. Higher scores are indicative of sleep disturbance.
Trial Locations
- Locations (1)
Washington DC Veteran's Affair Medical Center
🇺🇸Washington DC, District of Columbia, United States