## Protocol Section
### Identification Module
**NCT ID:** NCT06414109

**Brief Title:** Mindfulness-Based Intervention for Adolescents With Chronic Migraine

**Official Title:** Mindfulness-Based Intervention for Adolescents With Chronic Migraine

#### Organization Study ID Info
**ID:** 22-2359
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
### Status Module
#### Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Children's Hospital Colorado

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Colorado, Denver

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.

**Detailed Description:** Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by adapting an existing empirically-supported MBI for adolescents (Learning to BREATHE) to meet the unique needs of adolescents with chronic migraine. In Phase I of the study, we will use feedback solicited from interviews with teens with chronic migraine, their parents, and healthcare providers documenting the experience of living with chronic migraine and on the content and delivery of the MBI to create an adapted telehealth group intervention specifically tailored for adolescents with frequent migraine. In Phase II of the study, the adapted MBI will be piloted in a single-arm trial with adolescents with frequent migraine to assess feasibility, acceptability, and preliminary clinical signals.

### Conditions Module

**Conditions:**

- Migraine

- Migraine in Adolescence

**Keywords:**

- Adolescent

- Mindfulness

- Mindfulness Intervention

- Migraine

- Headache

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting.

**Intervention Names:**

- Behavioral: BREATHE-Migraine

**Label:** BREATHE-Migraine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BREATHE-Migraine

**Description:** The BREATHE-Migraine intervention was adapted from the research-supported curriculum, "Learning to BREATHE" (Broderick, 2021), based on qualitative feedback from adolescents with migraine, their parents, and pediatric headache providers. BREATHE-Migraine includes experiential and didactic exercises designed to address emotion regulation and the stress of living with frequent migraine.

**Name:** BREATHE-Migraine

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Percent of sessions attended; Qualitative data generated via focus group interviews (questions will include barriers and facilitators to completing the intervention)

**Measure:** Intervention feasibility

**Time Frame:** Up to 6 weeks

**Description:** Ratings on program acceptability questionnaire (higher scores indicate higher acceptability); Qualitative data generated via focus group interviews (questions will include positive and negative perceptions of the intervention)

**Measure:** Intervention acceptability

**Time Frame:** 7 weeks

#### Secondary Outcomes

**Description:** The Pediatric Migraine Disability Assessment (PedMIDAS) is a 6-item self-report questionnaire measuring the extent to which headaches interfered with school attendance and functioning, home functioning, and social attendance and functioning. Adolescents will be asked to indicate the number of days in the past 3 months in which they were unable to attend or fully participate in a range of activities. Lower scores indicate less disability.

**Measure:** Change in headache-related disability

**Time Frame:** Baseline, 6 weeks

**Description:** The Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) is an 18-item self-report measure of various dimensions of emotion dysregulation. Items are rated on a 6-point Likert scale ranging from 1 (almost never) to 5 (almost always). The DERS-SF provides a total score and 6 subscale scores. Lower scores indicate better emotion regulation.

**Measure:** Change in emotion regulation

**Time Frame:** Baseline, 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 13 to 18 years
* Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
* Patient report of \>= 8 headache days per month
* PedMIDAS Score of \> 10 (at least mild headache-related disability)

Exclusion Criteria:

* Weekly or bi-weekly therapy with a licensed behavioral health provider
* Major comorbid medical condition (e.g., cancer, epilepsy)
* Active psychosis or suicidal ideation
* Inability to provide consent/assent

**Maximum Age:** 18 Years

**Minimum Age:** 13 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** michelle.clementi@childrenscolorado.org

**Name:** Michelle A Clementi, PhD

**Phone:** 720-777-7487

**Role:** CONTACT

**Contact 2:**

**Email:** michelle.harmon@childrenscolorado.org

**Name:** Michelle Harmon, BS

**Phone:** 720-777-4904

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aurora

**Contacts:**

***Contact 1:***

- **Email:** michelle.clementi@childrenscolorado.org

- **Name:** Michelle A Clementi, PhD

- **Phone:** 720-777-7487

- **Role:** CONTACT

***Contact 2:***

- **Email:** michelle.harmon@childrenscolorado.org

- **Name:** Michelle Harmon, BS

- **Phone:** 720-777-4904

- **Role:** CONTACT

**Country:** United States

**Facility:** Children's Hospital Colorado

**State:** Colorado

**Zip:** 80045

#### Overall Officials

**Official 1:**

**Affiliation:** University of Colorado, Denver

**Name:** Michelle A Clementi, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000051270

- Term: Headache Disorders, Primary

- ID: D000020773

- Term: Headache Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9351

- Name: Headache

- Relevance: LOW

- As Found: Unknown

- ID: M11852

- Name: Migraine Disorders

- Relevance: HIGH

- As Found: Migraine

- ID: M22529

- Name: Headache Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26657

- Name: Headache Disorders, Primary

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008881

- Term: Migraine Disorders

### Misc Info Module

- Version Holder: 2024-05-31
