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Completed

NCT Number: NCT04164667

Telehealth Pilot for Veterans with Chronic Multi-Symptom Illness.

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.

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Key information

Conditions

Chronic Multisymptom Illness Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington DC Veteran's Affair Medical Center

Washington D.C., District of Columbia, 20422, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mental and physical (MAP) training intervention

Behavioral

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

Primary outcomes

  1. Feasibility (Recruitment rate)

    Time frame: 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.

  2. Feasibility (Retention rate)

    Time frame: 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.

  3. Feasibility (Adherence rate)

    Time frame: 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.

  4. Safety of administering a telehealth MAP intervention

    Time frame: Through study completion, an average of 6 months

    Number of adverse events reported during the intervention

  5. Acceptability

    Time frame: Through study completion, an average of 6 months

    Acceptability was quantified using the qualitative feedback provided by participants during their health coaching sessions.

Secondary outcomes

  1. Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)

    Time frame: 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.

  2. Patient Health Questionnaire- Depression scale (PHQ-9)

    Time frame: 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.

  3. Posttraumatic Symptom Checklist - Military version (PCL-M)

    Time frame: 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.

  4. Perceived Stress Scale (PSS)

    Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.

    To measure the perception of stress

  5. Brief Symptom Inventory (BSI)

    Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.

    To evaluate the degree of psychological distress.

  6. Five-Factor Mindfulness Questionnaire (FFMQ)

    Time frame: 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.

  7. Medical Outcomes Study Short-Form-36 version 2 (SF-36v2)

    Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.

    To assess quality of life (physical and mental).

  8. Cognitive Difficulties Scale (CDS)

    Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.

    To assess cognitive complaints.

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

War Related Illness and Injury Study Center

Fed

Collaborators

  • Georgetown University
  • Uniformed Services University of the Health Sciences

Registry information

Official study 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.

Acronym: Telehealth

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 15, 2019
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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