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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Directed MAP (dMAP) 		Participants received weekly text message directions from the ANNIE VA messaging system. The directed text messaging system provided details on which app-based meditation and exercise sessions to complete.
  • Behavioral: Mental and physical (MAP) training intervention
    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.
    Other names:
    • MAP training
Active Comparator
Self-Guided MAP (sgMAP) 		Participants received the intervention goals at the beginning of the study which included instruction on how to perform each of the individual components of the MAP protocol and how to use the study devices/apps, but they did not receive any further guidance during the intervention.
  • Behavioral: Mental and physical (MAP) training intervention
    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.
    Other names:
    • MAP training

More Details

Status
Completed
Sponsor
War Related Illness and Injury Study Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.