Trajectory of treatment response in the child and adolescent migraine prevention (CHAMP) study: A randomized clinical trial

Cephalalgia ◽  
2021 ◽  
pp. 033310242110335
Author(s):  
Brooke L Reidy ◽  
James Peugh ◽  
Andrew D Hershey ◽  
Christopher S Coffey ◽  
Leigh A Chamberlin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Treatment Response ◽  
Active Treatment ◽  
Behavioral Therapy ◽  
Headache Frequency ◽  
Migraine Prevention ◽  
Prevention Study ◽  
Treatment Models ◽  
Daily Headache

Objective Identify preventive medication treatment response trajectories among youth participating in the Childhood and Adolescent Migraine Prevention study. Methods Data were evaluated from 328 youth (ages 8–17). Childhood and Adolescent Migraine Prevention study participants completed headache diaries during a 28-day baseline period and a 168-day active treatment period during which youth took amitriptyline, topiramate, or placebo. Daily headache occurrence trajectories were established across baseline and active treatment periods using longitudinal hierarchical linear modeling. We tested potential treatment group differences. We also compared final models to trajectory findings from a clinical trial of cognitive behavioral therapy plus amitriptyline for youth with chronic migraine to test for reproducibility. Results Daily headache occurrence showed stability across baseline. Active treatment models revealed decreases in headache frequency that were most notable early in the trial period. Baseline and active treatment models did not differ by treatment group and replicated trajectory cognitive behavioral therapy plus amitriptyline trial findings. Conclusions Replicating headache frequency trajectories across clinical trials provides strong evidence that youth can improve quickly. Given no effect for medication, we need to better understand what drives this clinically meaningful improvement. Results also suggest an expected trajectory of treatment response for use in designing and determining endpoints for future clinical trials. Trial Registration. ClinicalTrials.gov Identifier: NCT01581281

scholarly journals Practice guideline update summary: Pharmacologic treatment for pediatric migraine prevention

Neurology ◽  
2019 ◽  
Vol 93 (11) ◽  
pp. 500-509 ◽  
Author(s):  
Maryam Oskoui ◽  
Tamara Pringsheim ◽  
Lori Billinghurst ◽  
Sonja Potrebic ◽  
Elaine M. Gersz ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Children And Adolescents ◽  
Behavioral Therapy ◽  
Pediatric Population ◽  
Cognitive Behavioral ◽  
Headache Frequency ◽  
Pharmacologic Treatment ◽  
Migraine Prevention ◽  
Pediatric Migraine ◽  
Pharmacologic Treatments

ObjectiveTo provide updated evidence-based recommendations for migraine prevention using pharmacologic treatment with or without cognitive behavioral therapy in the pediatric population.MethodsThe authors systematically reviewed literature from January 2003 to August 2017 and developed practice recommendations using the American Academy of Neurology 2011 process, as amended.ResultsFifteen Class I–III studies on migraine prevention in children and adolescents met inclusion criteria. There is insufficient evidence to determine if children and adolescents receiving divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, or flunarizine are more or less likely than those receiving placebo to have a reduction in headache frequency. Children with migraine receiving propranolol are possibly more likely than those receiving placebo to have an at least 50% reduction in headache frequency. Children and adolescents receiving topiramate and cinnarizine are probably more likely than those receiving placebo to have a decrease in headache frequency. Children with migraine receiving amitriptyline plus cognitive behavioral therapy are more likely than those receiving amitriptyline plus headache education to have a reduction in headache frequency.RecommendationsThe majority of randomized controlled trials studying the efficacy of preventive medications for pediatric migraine fail to demonstrate superiority to placebo. Recommendations for the prevention of migraine in children include counseling on lifestyle and behavioral factors that influence headache frequency and assessment and management of comorbid disorders associated with headache persistence. Clinicians should engage in shared decision-making with patients and caregivers regarding the use of preventive treatments for migraine, including discussion of the limitations in the evidence to support pharmacologic treatments.

scholarly journals Mobile Behavioral Therapy for Headache: Pilot Study (Preprint)

2018 ◽  
Author(s):  
Adam Kirell ◽  
Rebecca Shingleton
Keyword(s):  
Mobile Health ◽  
Relaxation Training ◽  
Medical Condition ◽  
Behavioral Therapy ◽  
Mobile App ◽  
Headache Frequency ◽  
Intervention Period ◽  
Headache Diary ◽  
Daily Headache ◽  
Training Exercises

BACKGROUND Frequently recurring tension headaches, migraines, and orofacial pain affect over 2.4 billion people worldwide, representing the second most prevalent medical condition in the world. In-office behavioral therapy (ie, relaxation and mindfulness exercises) has been shown to be one of the most effective treatment options for these patients. However, it has been underutilized due to stigma, cost, and accessibility. Mobile health apps may be one way to provide accessible, lower cost care in a nonstigmatized environment. As a result, apps are becoming an increasingly popular method for delivering behavioral therapy interventions and may provide an effective means to reach this population. OBJECTIVE The aim of this study was to assess the feasibility and acceptability of delivering a clinically validated behavioral therapy for migraine/headaches through a mobile app. METHODS Twenty-one migraine or headache sufferers met the criteria for severe migraine disability determined by the MIDAS test. Participants completed a two-week baseline period in which they kept a daily headache diary through the Halo app. They then began a four-week intervention period. During this period they were instructed to complete ten minutes of relaxation training exercises provided by the app each day, as well as monitor headaches via the daily headache diary. Relaxation training exercises consisted of various breathing techniques, progressive muscle relaxation, and mindfulness. Headache frequency was tracked throughout the intervention period, and further assessments, such as an in-person interview and posttreatment MIDAS test, were completed at the end of the four-week intervention period. RESULTS Analysis of data showed that there were significant differences between baseline scores (Headache Frequency Average=11.47/mo, MIDAS average=25.4) and postintervention follow-up (Headache Frequency Average=6.63/mo, MIDAS average=11.7, Frequency P<.01, MIDAS P<.01). Postintervention interviews revealed that more than 90% of the participants felt that the Halo beta app was easy to use and provided a benefit to the user. More than 85% of participants enjoyed using a daily headache diary and felt it gave them greater insights into their condition. More than 90% of the patients felt that the relaxation training had helped reduce the frequency of their headaches or headache related disability. CONCLUSIONS We found that mindfulness and relaxation-based interventions administered through the Halo beta app was a feasible and acceptable treatment for people suffering from frequently recurring headaches and migraines or disability associated with headaches and migraines. The pilot demonstrated the potential feasibility and usability of a mobile health app in delivering behavioral therapy for headache and migraine as an adjunct or alternative to in-office behavioral therapy for headache and migraine.

Assessing the Onset of Relief of a Treatment for Migraine

Cephalalgia ◽  
2000 ◽  
Vol 20 (8) ◽  
pp. 724-731 ◽  
Author(s):  
EM Laska ◽  
C Siegel
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conceptual Framework ◽  
Active Treatment ◽  
Clinical Characteristics ◽  
Survival Distribution ◽  
Using Data

It is common for clinical trials designed to compare treatments for migraine to incorporate a component for estimating onset. Our objective is to describe a stopwatch method for collecting data on time to meaningful relief and a conceptual framework for describing and analysing the results. The survival distribution of onset is modelled in two parts: the probability that onset does not occur, and the survival distribution conditional on its occurrence. Using data from a clinical trial comparing an active treatment and placebo, we illustrate the method and find that the distributions of onset among those with onset do not differ, but the probabilities that onset occurs are substantially different. We illustrate how the model can be used to help determine how long patients without onset should wait before further intervention, how patients interpret the phrase meaningful relief, and how baseline clinical characteristics affect the onset.

scholarly journals Multi-Level Assessment Protocol (MAP) for Adoption in Multisite Clinical Trials

2005 ◽  
Vol 35 (3) ◽  
pp. 529-546 ◽  
Author(s):  
Joseph Guydish ◽  
Sarah Turcotte Manser ◽  
Martha Jessup ◽  
Barbara Tajima ◽  
Clare Sears ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Qualitative Research ◽  
Clinical Trials ◽  
Drug Abuse ◽  
Drug Abuse Treatment ◽  
Assessment Protocol ◽  
Protocol Development ◽  
Treatment Models ◽  
Multi Level ◽  
Abuse Treatment

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multisite clinical trials and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked the following question: how might the technology of multisite clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing eight organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. Analysis of interview data revealed four conceptual themes likely to affect adoption and may be informative in future multisite clinical trials. Planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice.

scholarly journals Participating in HIV Prevention Clinical Trial: Reasons and Experiences among Female Participants in Antibody Mediated Prevention Study at UNC Project, Lilongwe, Malawi

2020 ◽  
Author(s):  
Ruth Holla ◽  
Adamson Muula
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Hiv Prevention ◽  
Cross Sectional Study ◽  
Prevention Study ◽  
Cross Sectional ◽  
Prevention Clinical Trial ◽  
Hiv Research ◽  
Project Data ◽  
Study Participants

Aim: The overall aim of the study was to assess the reasons and experiences of participants involved in Antibody Mediated Prevention (AMP) HIV prevention clinical trial at University of North Carolina (UNC) Project, Lilongwe, Malawi. We determined the participants&rsquo; reasons for participating in HIV Prevention clinical trials; and the experiences of participants in HIV Prevention clinical trials. Methods: We adopted the qualitative cross-sectional study method. Data were collected using in-depth interviews (IDIs). Purposive sampling was used to select 12 study participants who consented to take part in the study. All participants were the ones taking part in the AMP HIV prevention study at the UNC Project. Data analysis was done concurrently with data collection using content analysis. Results: Individuals were motivated to participate in HIV research due to a range of perceived benefits. These included personal, health, and financial benefits. Participants' research experiences and their continued participation in HIV research were influenced by the research clinic context and the nature of their interactions with research staff. Conclusion: When the clinical trial study participants&rsquo; expectations are met through what they experience in the study, the chances of them adhering to the study visits and procedures are high. Even for those who did not have any expectations prior to the study, feeling welcomed and being able to open up to the study staff encouraged their continued participation. In the end, this outweighed the negative comments made by the people in their communities or their friends

Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

1990 ◽  
Vol 29 (03) ◽  
pp. 243-246 ◽  
Author(s):  
M. A. A. Moussa
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Event Rate ◽  
Survival Functions ◽  
Time Intervals ◽  
Patient Noncompliance ◽  
Event Rates ◽  
Larger Sample

AbstractVarious approaches are considered for adjustment of clinical trial size for patient noncompliance. Such approaches either model the effect of noncompliance through comparison of two survival distributions or two simple proportions. Models that allow for variation of noncompliance and event rates between time intervals are also considered. The approach that models the noncompliance adjustment on the basis of survival functions is conservative and hence requires larger sample size. The model to be selected for noncompliance adjustment depends upon available estimates of noncompliance and event rate patterns.

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