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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
24
In this study, the MAP intervention consisted of two MAP training sessions and one health coaching session per week for eight weeks. Both groups received the same MAP intervention with the exception of the delivery format (directed versus self-guided). Each MAP training session included 30 minutes of guided meditation and 30 minutes of moderate-to-vigorous aerobic exercise.
Washington DC Veteran's Affair Medical Center
Washington D.C., District of Columbia, United States
Feasibility (Recruitment rate)
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.
Time frame: Through study completion, an average of 6 months
Feasibility (Retention rate)
Retention rate was calculated for each time point (endpoint and 3m follow-up) and reported as a percentage.
Time frame: Through study completion, an average of 6 months
Feasibility (Adherence rate)
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.
Time frame: Through study completion, an average of 6 months
Safety of administering a telehealth MAP intervention
Number of adverse events reported during the intervention
Time frame: Through study completion, an average of 6 months
Acceptability
Acceptability was quantified using the qualitative feedback provided by participants during their health coaching sessions.
Time frame: Through study completion, an average of 6 months
Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
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.
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Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Patient Health Questionnaire- Depression scale (PHQ-9)
The PHQ-9 was used to assess the severity of depression symptoms. Higher scores are indicative of greater depression symptoms.
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Posttraumatic Symptom Checklist - Military version (PCL-M)
To evaluate the severity of PTSD symptoms in an individual who has had military experience. Higher scores are indicative of greater PTSD symptoms.
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Perceived Stress Scale (PSS)
To measure the perception of stress
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Brief Symptom Inventory (BSI)
To evaluate the degree of psychological distress.
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Five-Factor Mindfulness Questionnaire (FFMQ)
To evaluate mindfulness across five domains: Awareness, Describing, Non-judging of Inner Experience, Non-reactivity to Inner Experience, and Observing.
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Medical Outcomes Study Short-Form-36 version 2 (SF-36v2)
To assess quality of life (physical and mental).
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Cognitive Difficulties Scale (CDS)
To assess cognitive complaints.
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Pittsburgh Sleep Quality Index (PSQI)
To measure the quality and patterns of sleep in adults. Higher scores are indicative of sleep disturbance.
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.