Distinct Mechanisms of Cognitive Behavioral Therapy Effects in Youth With Migraine
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|ClinicalTrials.gov Identifier: NCT03472092|
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Headache, Migraine Migraine Migraine Disorders Headache||Behavioral: Cognitive Behavioral Therapy (CBT) Drug: Placebo Drug: Amitriptyline||Phase 2|
Pediatric migraine is a prevalent disorder that results in significant pain and disability for children and adolescents. Little is known about the distinct brain changes that occur in youth with migraine when they receive cognitive behavioral therapy, which is known to decrease headache days for these patients. Pediatric medical and behavioral clinicians can use mechanistic insights from this study to provide patients and families with a stronger rationale for treatment, thereby decreasing stigma and increasing confidence in and commitment to the care plan.
This project will study migraine, which affects > 6 million youth in the U.S. Cochrane reviews show that psychological therapies for pediatric headache result in better outcomes than control conditions (56% improved vs. 22% in 714 participants), and our CBT+Amitriptyline Study found that 66% of youth with chronic migraine had a ≥ 50% reduction in headache days compared to 36% in an education control+Amitriptyline (AMI) group. Despite this evidence base, the neural mechanisms supporting the efficacy of CBT for pain remain poorly understood. The lack of mechanistic understanding is a barrier to treatment utilization, particularly given the time, effort, and expense for pediatric migraine patients to receive CBT vs. conventional pharmacological therapy (which in a national trial reduced headache days similar to placebo pill: AMI 52% of participants improved; Placebo 61%). Pilot data from the investigators demonstrate that: CBT induces changes in brain connectivity/activation, and QST at baseline predicts reduced migraines at 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Mechanistic trial examining brain changes and conditioned pain modulation changes in youth with migraine treated with either cognitive behavioral therapy, placebo, or amitriptyline.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Cognitive behavioral therapy assignment is known to the treating therapist/care provider. Placebo and amitriptyline are double blinded.|
|Primary Purpose:||Basic Science|
|Official Title:||Distinct Mechanisms of Cognitive Behavioral Therapy Effects in Youth With Migraine: Insights From Neuroimaging and Quantitative Sensory Testing (The How and Why Youth With Headaches Get Better)|
|Actual Study Start Date :||October 2, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||March 2023|
Experimental: Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.
Behavioral: Cognitive Behavioral Therapy (CBT)
This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).
Placebo Comparator: Placebo
The placebo pill will be administered once a day at home, to be taken by mouth.
The placebo pill will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study.
Other Name: Placebo Oral Capsule
Active Comparator: Amitriptyline
Amitriptyline will be administered once a day at home, to be taken by mouth. Dosage will be weight-based.
Amitriptyline will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study. For this study, a dose of 0.25 mg/kg/day will be provided for the 1st 2 weeks, followed by a dose of 0.5 mg/kg/day for 2 weeks, 0.75 mg/kg/day for 2 weeks and a maximum dose of 1.0 mg/kg/day for 2 weeks based on tolerability. Participants experiencing tolerability issues, may be held a current dose rather than titrated to the next dosage if deemed appropriate by the study doctor.
- Change in functional resonance imaging (fMRI) [ Time Frame: baseline and post treatment (8 weeks post randomization) ]For each participant, changes in distinct neural mechanisms of the brain will be compared to between baseline and post treatment (8 weeks). For each participant, the primary endpoint will be examine changes in brain connectivity and activation.
- Change in pain modulation [ Time Frame: baseline and post treatment (8 weeks post randomization) ]For each participant, changes in the efficiency of pain modulation using a quantitative sensory testing paradigm will be assessed. This outcome will compare between baseline and post treatment (8 weeks).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472092
|Contact: LeighAnn Chamberlin, MEdfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: LeighAnn Chamberlin, MEd 513-939-9739 email@example.com|
|Principal Investigator: Scott Powers, PhD|
|Principal Investigator: Robert Coghill, PhD|
|Principal Investigator:||Scott Powers, PhD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Robert Coghill, PhD||Children's Hospital Medical Center, Cincinnati|