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| Name | Class |
|---|---|
| Georgetown University | OTHER |
| Uniformed Services University of the Health Sciences | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Reinhard, PsyD | DC WRIISC Director | Principal Investigator |
| Michelle Costanzo, PhD | DC WRIIISC Research Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington DC Veteran's Affair Medical Center | Washington D.C. | District of Columbia | 20422 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40205557 | Derived | 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. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| 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. |