Telehealth Pilot for Veterans with Chronic Multi-Symptom Illness. (Telehealth)

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Multisymptom Illness
• Intervention / Treatment: Behavioral: Mental and physical (MAP) training intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington DC, District of Columbia, United States, 20422
      • Washington DC Veteran's Affair Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Through study completion, an average of 6 months
Safety of administering a telehealth MAP intervention	Number of adverse events reported during the intervention	Through study completion, an average of 6 months
Acceptability	Acceptability was quantified using the qualitative feedback provided by participants during their health coaching sessions.	Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to Endpoint (2 months) and baseline to 5 months.
Perceived Stress Scale (PSS)	To measure the perception of stress	Baseline to Endpoint (2 months) and baseline to 5 months.
Brief Symptom Inventory (BSI)	To evaluate the degree of psychological distress.	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.	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).	Baseline to Endpoint (2 months) and baseline to 5 months.
Cognitive Difficulties Scale (CDS)	To assess cognitive complaints.	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.	Baseline to Endpoint (2 months) and baseline to 5 months.

Collaborators and Investigators

• Sponsor: War Related Illness and Injury Study Center
• Collaborators: Georgetown University; Uniformed Services University of the Health Sciences
• Investigators: Principal Investigator: Matthew Reinhard, PsyD, DC WRIISC Director; Principal Investigator: Michelle Costanzo, PhD, DC WRIIISC Research Director

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): July 6, 2021
• Study Completion (Actual): July 6, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Veterans; Telehealth; Meditation; Health Coaching
• Other Study ID Numbers: 01880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No