Telehealth Pilot for Veterans with Chronic Multi-Symptom Illness.

NCT ID: NCT04164667

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2021-07-06

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.

Conditions

Chronic Multisymptom Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mental and physical (MAP) training intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Mental and physical (MAP) training intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MAP training

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

War Related Illness and Injury Study Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Reinhard, PsyD

Role: PRINCIPAL_INVESTIGATOR

DC WRIISC Director

Michelle Costanzo, PhD

Role: PRINCIPAL_INVESTIGATOR

DC WRIIISC Research Director

Locations

Washington DC Veteran's Affair Medical Center

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

Countries

United States

References

Breneman CB, Pollin K, Chun T, Crock L, Jachimowicz W, McCullers RA, Brewster RC, Alaoui A, Belouali A, Roy MJ, Reinhard MJ, Costanzo ME. Determining the feasibility and acceptability of a randomized telehealth pilot study for veterans with chronic multisymptom illness. Pilot Feasibility Stud. 2025 Apr 9;11(1):43. doi: 10.1186/s40814-025-01628-2.

Reference Type: DERIVED

PMID: 40205557 (View on PubMed)

Other Identifiers

01880

Identifier Type: -

Identifier Source: org_study_id