Chronic Multisymptom IllnessTelehealthNCT04164667

Telehealth Pilot for Veterans with Chronic Multi-Symptom Illness.

A study testing Mental and physical (MAP) training intervention in people with Chronic Multisymptom Illness, run by War Related Illness and Injury Study Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Multisymptom Illness
What is being tested?: Mental and physical (MAP) training intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 17 Nov 2017to 6 Jul 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington DC Veteran's Affair Medical Center
Washington D.C., District of Columbia, 20422

Other trials in United States

About this study

Official 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.

Read the 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
Being tested: Mental and physical (MAP) training intervention
Keywords: Telehealth, Veterans, Exercise, Meditation, Health Coaching
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mental and physical (MAP) training interventionBehavioural
Also called MAP training
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.

Study groups in NCT04164667
Study group	Role	What they receive
Directed MAP (dMAP)	Experimental	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. Receives: Behavioral: Mental and physical (MAP) training intervention
Self-Guided MAP (sgMAP)	Active comparator	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. Receives: Behavioral: Mental and physical (MAP) training intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 20176 Jul 2021

First posted15 Nov 2019
Study start17 Nov 2017
Primary completion6 Jul 2021
Study completion6 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Multisymptom IllnessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04164667
Sponsor's protocol ID: 01880
Acronym: Telehealth
Status last verified: Oct 2024
First submitted: 5 Nov 2019
Last updated: 4 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40205557

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Multisymptom Illness trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT04164667
Acronym / sponsor ID: Telehealth / 01880
Conditions: Chronic Multisymptom Illness
Keywords: Telehealth, Veterans, Exercise, Meditation, Health Coaching
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: War Related Illness and Injury Study CenterUS federal agency
Collaborators: Georgetown University, Uniformed Services University of the Health Sciences
Study start: 17 Nov 2017 (actual)
Primary completion: 6 Jul 2021 (actual)
Study completion: 6 Jul 2021 (actual)
First posted: 15 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Directed MAP (dMAP)	Experimental	Behavioral: Mental and physical (MAP) training interventionParticipants 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.
Self-Guided MAP (sgMAP)	Active comparator	Behavioral: Mental and physical (MAP) training interventionParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mental and physical (MAP) training interventionAlso: MAP trainingIn 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.	Behavioural	Directed MAP (dMAP), Self-Guided MAP (sgMAP)

Primary outcome

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.
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.
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.
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
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.

9 secondary outcomes

Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Patient Health Questionnaire- Depression scale (PHQ-9)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Posttraumatic Symptom Checklist - Military version (PCL-M)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Perceived Stress Scale (PSS)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Brief Symptom Inventory (BSI)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Five-Factor Mindfulness Questionnaire (FFMQ)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Medical Outcomes Study Short-Form-36 version 2 (SF-36v2)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Cognitive Difficulties Scale (CDS)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline to Endpoint (2 months) and baseline to 5 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Derived from this study: PubMed 40205557Breneman 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.
Individual participant dataSharing planned: No

Related trials for Chronic Multisymptom Illness

RecruitingPhase 2
Ca-Mg Butyrate in Gulf War Illness
Gulf War Illness, Chronic Fatigue
Not yet recruitingPhase 2
Mitigating Toxic Impact: The Role of Coenzyme Q10 in Post-Exposure Protection
Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities
Recruiting
Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness
Persian Gulf Syndrome, Gulf War Syndrome
Recruiting
Care for Veterans Post-COVID-19
Post-Acute COVID-19 Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew Reinhard, PsyD principal investigator

DC WRIISC Director

Michelle Costanzo, PhD principal investigator

DC WRIIISC Research Director

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mental and physical (MAP) training intervention in people with Chronic Multisymptom Illness, run by War Related Illness and Injury Study Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (Recruitment rate) (time frame: Through study completion, an average of 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04164667, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.