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| ID | Type | Description | Link |
|---|---|---|---|
| U01AT010132 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.
In the United States, over 6 million children and adolescents suffer from migraine headaches and it is 1 of the 5 most prevalent childhood disorders. Mind and body approaches can significantly help these youth, but getting access to this type of treatment is a challenge for families. Our mind and body study will test a mind and body intervention package delivered by health care professionals (i.e., nurses) introducing coping skills to youth ages 10 to 17 that have migraine.
Using a factorial design and the multiphase optimization strategy "MOST", in this study we are able to evaluate different doses of 3 treatment components (1. Duration of mind and body skill introduction session; 2. Home practice support intensity; and 3. Adherence prompt phone call) in one project. A screening experiment will be conducted to determine the dose of each treatment component for future evaluation of the optimized intervention package in a pragmatic or SMART trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 minute session, home practice e-health, phone call | Experimental | This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice. |
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| 40 minute session, home practice e-health, no phone call | Experimental | This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice. |
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| 40 minute session, home practice handout, phone call | Experimental | This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice. |
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| 40 minute session, home practice handout, no phone call |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40 minute session | Behavioral | The 40 minute session will include all of the content contained in the 20 minute session, but will include a greater explanation of each of the mind and body skills, followed by in vivo practice of each skill with the nurse. Sessions will also include review of home practice for each group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of headache days | This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between the treatment groups over time. This will be assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days before the endpoint visit. | baseline to post treatment (8 weeks post randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in absolute headache disability score on PedMIDAS | The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this study. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and adherence to the session time component | Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the session time component a threshold of reasonable feasibility/adherence is specified as: nurse fidelity to introduction dose times (20 min versus 40 min) with fidelity measured as proportion of interactions where the documented time is within 5 minutes of the intended duration (i.e., 15 to 25 minutes for the 20-minute dose and 35 to 45 minutes for the 40-minute dose, as measured by nurse report at the time of the session). The acceptable threshold will be at least 80 percent fidelity within the given time window. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LeighAnn Chamberlin, MEd | Contact | 513-636-9739 | leighann.chamberlin@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Scott Powers, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado/Children's Hospital Colorado | Active, not recruiting | Aurora | Colorado | 80045 | United States | |
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Only than study staff whose role requires unblinding (project manager and the nurse or interventionist providing the treatment) will be made aware of each participant's study assignment by the statistician. Other study personnel (including assessors of key variables) will remain blinded to treatment assignment.
| Experimental |
This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice. |
|
| 20 minute session, home practice e-health, phone call | Experimental | This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice. |
|
| 20 minute session, home practice e-health, no phone call | Experimental | This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice. |
|
| 20 minute session, home practice handout, phone call | Experimental | This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice. |
|
| 20 minute session, home practice handout, no phone call | Experimental | This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice. |
|
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| 20 minute session | Behavioral | For participants randomized to the 20 minute session, content will include pain education, followed by brief explanations of each of the mind and body skills, in vivo diaphragmatic breathing practice and demonstration of use of biofeedback card. Sessions will also include review of home practice for each group. |
|
| home practice e-health | Behavioral | Participants will be provided and instructed on access to a migraine-specific interactive web portal, Migraine e-Health. This web-based tool actively guides participants in practicing evidence-based mind and body skills. Use of the Migraine -e-Health application for the high dose capitalizes on teaching participants mind and body skills while increasing accessibility due to implementation on mobile devices. |
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| home practice handout | Behavioral | Participants will be given a handout of commercially available free apps relevant to the mind body skills introduced. |
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| phone call | Behavioral | The dose of phone call will occur about 4 weeks following the face-to-face mind and body introduction session and will last approximately 5-10 minutes. The phone call will be used to promote adherence to home-practice and answer questions related to skill use/home practice completion. |
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| baseline to post treatment (8 weeks post randomization) |
| baseline to post treatment (8 weeks post randomization) |
| Feasibility and adherence to the home practice component | Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the home practice component a threshold of reasonable feasibility/adherence is specified as: eHealth versus handout - threshold >33% of practice days completed on average will be defined as sufficient adherence for both conditions. | baseline to post treatment (8 weeks post randomization) |
| Feasibility and adherence to the phone call component | Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the phone call component a threshold of reasonable feasibility/adherence is specified as: 50% of phone calls completed will be considered feasible/adherent for the phone call follow-up. No threshold is set for the participants who do not receive a phone call follow-up. | baseline to post treatment (8 weeks post randomization) |
| Cincinnati Children's Hospital Medical Center |
| Recruiting |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
|
| ID | Term |
|---|---|
| D006261 | Headache |
| D020773 | Headache Disorders |
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051270 | Headache Disorders, Primary |
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