Responding With Evidence and Access for Childhood Headaches

Conditions

• Chronic Migraine
• Headache
• Headache Disorders
• Headache, Migraine
• Migraine
• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura

Eligibility Criteria

Sex

ALL

Age

10 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• CBT — BEHAVIORAL
  During an 8-week active treatment, participants will receive 6 telehealth CBT sessions, followed by a maintenance phase (16 weeks) when participants will receive 3 "booster" CBT sessions. The sessions will be conducted by teletherapists from the Clinical Coordinating Center at Cincinnati Children's using a standardized treatment manual. A parent/legal guardian will be included in 2 sessions teaching ways to be active coaches, encouraging use of effective coping skills and refraining from reinforcement of maladaptive coping. Each session will be about 45 minutes.
• Amitriptyline — DRUG
  During an 8-week active treatment, participants will begin taking a daily pill (amitriptyline) prescribed and managed clinically by the site headache provider. Amitriptyline will be taken once a day before bedtime. The weight based dosage will gradually be increased based on tolerability and a standardized titration protocol during the 8 week active treatment. The participant will remain on a maximum tolerated dose for the final 16 weeks (maintenance).

Study Details

This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.

Key Dates

Start date

Aug 22, 2023

Status verified

Mar 2026

Primary completion

Jul 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline)
  This intervention consists of Cognitive Behavioral (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. This arm will also take a daily oral dose of Amitriptyline, which will be clinically prescribed and managed by the patient's headache provider.
• Experimental: CBT alone
  This intervention arm consists of 6 Cognitive Behavioral Therapy (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.

Primary Outcome Measure

Change in number of headache days [ Time Frame: baseline to weeks 4-8 to weeks 20-24 (post treatment) ]

Central Contacts

• LeighAnn Chamberlin, MEd
  513-636-9739
  [email protected]
• Megan Pfeiffer
  513-636-1846
  [email protected]

Locations (15)

Find similar trials in Birmingham, AL

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