Dataset Information

Trajectory of Improvement in Children and Adolescents With Chronic Migraine: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial.

ABSTRACT: We compared headache frequency trajectories between clinical trial participants who received cognitive-behavioral therapy (CBT) and amitriptyline (CBT+A) or headache education (HE) and amitriptyline (HE+A) to determine if there was a differential time course of treatment response between the groups. One hundred thirty-five patients (age 10-17 years) diagnosed with chronic migraine participated, attending 8 one-hour one-on-one CBT or HE sessions with a trained psychologist for 8 weekly sessions, 2 sessions at weeks 12 and 16, and a post-treatment visit at week 20. Participants kept daily headache diaries and completed take-home assignments between visits. Data from daily headache diaries are presented for each day and according to 28-day periods. Trajectories of improvement indicate initial decrease in headache days began during the first month of treatment, for both groups, and continued to decrease throughout treatment. The CBT+A group had greater daily improvement than the HE+A group. A significantly greater proportion of the CBT+A group had a ≥50% reduction in headache days each month, and a significantly greater proportion of the CBT+A group had ≤4 headache days per month in months 3 through 5. Results indicate the trajectory of decrease in headache days is significantly better for patients receiving CBT+A versus HE+A.

Perspective

This article presents daily information about headache frequency over a 20-week clinical trial. Youth with chronic migraine who received CBT+A improved faster than those in the control group. Findings provide clinicians with evidence-based expectations for treatment response over time and ways of monitoring treatment success.

Trial registration

clinicaltrials.gov identifier NCT00389038.

SUBMITTER: Kroner JW

PROVIDER: S-EPMC5457327 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

Trajectory of Improvement in Children and Adolescents With Chronic Migraine: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial.

Kroner John W JW Peugh James J Kashikar-Zuck Susmita M SM LeCates Susan L SL Allen Janelle R JR Slater Shalonda K SK Zafar Marium M Kabbouche Marielle A MA O'Brien Hope L HL Shenk Chad E CE Kroon Van Diest Ashley M AM Hershey Andrew D AD Powers Scott W SW

The journal of pain 20170118 6

We compared headache frequency trajectories between clinical trial participants who received cognitive-behavioral therapy (CBT) and amitriptyline (CBT+A) or headache education (HE) and amitriptyline (HE+A) to determine if there was a differential time course of treatment response between the groups. One hundred thirty-five patients (age 10-17 years) diagnosed with chronic migraine participated, attending 8 one-hour one-on-one CBT or HE sessions with a trained psychologist for 8 weekly sessions, ...[more]

PMID: 28108386

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Project description:ImportanceEarly, safe, effective, and durable evidence-based interventions for children and adolescents with chronic migraine do not exist.ObjectiveTo determine the benefits of cognitive behavioral therapy (CBT) when combined with amitriptyline vs headache education plus amitriptyline.Design, setting, and participantsA randomized clinical trial of 135 youth (79% female) aged 10 to 17 years diagnosed with chronic migraine (≥15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to the CBT plus amitriptyline group (n = 64) or the headache education plus amitriptyline group (n = 71). The study was conducted in the Headache Center at Cincinnati Children's Hospital between October 2006 and September 2012; 129 completed 20-week follow-up and 124 completed 12-month follow-up.InterventionsTen CBT vs 10 headache education sessions involving equivalent time and therapist attention. Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit. In addition, follow-up visits were conducted at 3, 6, 9, and 12 months.Main outcomes and measuresThe primary end point was days with headache and the secondary end point was PedMIDAS (disability score range: 0-240 points; 0-10 for little to none, 11-30 for mild, 31-50 for moderate, >50 for severe); both end points were determined at 20 weeks. Durability was examined over the 12-month follow-up period. Clinical significance was measured by a 50% or greater reduction in days with headache and a disability score in the mild to none range (<20 points).ResultsAt baseline, there were a mean (SD) of 21 (5) days with headache per 28 days and the mean (SD) PedMIDAS was 68 (32) points. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group (difference, 4.7 [95% CI, 1.7-7.7] days; P = .002). The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group (difference, 14.1 [95% CI, 3.3-24.9] points; P = .01). In the CBT group, 66% had a 50% or greater reduction in headache days vs 36% in the headache education group (odds ratio, 3.5 [95% CI, 1.7-7.2]; P < .001). At 12-month follow-up, 86% of the CBT group had a 50% or greater reduction in headache days vs 69% of the headache education group; 88% of the CBT group had a PedMIDAS of less than 20 points vs 76% of the headache education group. Measured treatment credibility and integrity was high for both groups.Conclusions and relevanceAmong young persons with chronic migraine, the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline. These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents.Trial registrationclinicaltrials.gov Identifier: NCT00389038.

Project description:IntroductionIt is well-established that chronic exposure to environmental toxins can have adverse effects on neuropsychological health, particularly in developing youths. However, home radon, a ubiquitous radiotoxin, has been seldom studied in this context. In the present study, we investigated the degree to which chronic everyday home radon exposure was associated with alterations in transdiagnostic mental health outcomes.MethodsA total of 59 children and adolescents ages 6- to 14-years-old (M = 10.47 years, SD = 2.58; 28 males) completed the study. Parents completed questionnaires detailing aspects of attention and executive function. We used a principal components analysis to derive three domains of neuropsychological functioning: 1) task-based executive function skills, 2) self-and emotion-regulation abilities, and 3) inhibitory control. Additionally, parents completed a home radon test kit and provided information on how long their child had lived in the tested home. We computed a radon exposure index per person based on the duration of time that the child had lived in the home and their measured home radon concentration. Youths were divided into terciles based on their radon exposure index score. Using a MANCOVA design, we determined whether there were differences in neuropsychological domain scores across the three groups, controlling for age, sex, and socioeconomic status.ResultsThere was a significant multivariate effect of radon group on neuropsychological dysfunction (λ = 0.77, F = 2.32, p = 0.038, ηp2 = 0.12). Examination of univariate effects revealed specific increases in self-and emotion-regulation dysfunction among the youths with the greatest degree of chronic home radon exposure (F = 7.21, p = 0.002, ηp2 = 0.21). There were no significant differences by group in the other tested domains.DiscussionThe data suggest potential specificity in the neurotoxic effects of everyday home radon exposure in developing youths, with significant aberrations in self-and emotion-regulation faculties. These findings support the need for better public awareness and public health policy surrounding home radon safety and mitigation strategies.

Project description:BackgroundWhich medication, if any, to use to prevent the headache of pediatric migraine has not been established.MethodsWe conducted a randomized, double-blind, placebo-controlled trial of amitriptyline (1 mg per kilogram of body weight per day), topiramate (2 mg per kilogram per day), and placebo in children and adolescents 8 to 17 years of age with migraine. Patients were randomly assigned in a 2:2:1 ratio to receive one of the medications or placebo. The primary outcome was a relative reduction of 50% or more in the number of headache days in the comparison of the 28-day baseline period with the last 28 days of a 24-week trial. Secondary outcomes were headache-related disability, headache days, number of trial completers, and serious adverse events that emerged during treatment.ResultsA total of 361 patients underwent randomization, and 328 were included in the primary efficacy analysis (132 in the amitriptyline group, 130 in the topiramate group, and 66 in the placebo group). The trial was concluded early for futility after a planned interim analysis. There were no significant between-group differences in the primary outcome, which occurred in 52% of the patients in the amitriptyline group, 55% of those in the topiramate group, and 61% of those in the placebo group (amitriptyline vs. placebo, P=0.26; topiramate vs. placebo, P=0.48; amitriptyline vs. topiramate, P=0.49). There were also no significant between-group differences in headache-related disability, headache days, or the percentage of patients who completed the 24-week treatment period. Patients who received amitriptyline or topiramate had higher rates of several adverse events than those receiving placebo, including fatigue (30% vs. 14%) and dry mouth (25% vs. 12%) in the amitriptyline group and paresthesia (31% vs. 8%) and weight loss (8% vs. 0%) in the topiramate group. Three patients in the amitriptyline group had serious adverse events of altered mood, and one patient in the topiramate group had a suicide attempt.ConclusionsThere were no significant differences in reduction in headache frequency or headache-related disability in childhood and adolescent migraine with amitriptyline, topiramate, or placebo over a period of 24 weeks. The active drugs were associated with higher rates of adverse events. (Funded by the National Institutes of Health; CHAMP ClinicalTrials.gov number, NCT01581281 ).

Project description:BACKGROUND AND OBJECTIVES:This study examined the occurrence of sudden gains (or reversal of gains) among children with obsessive-compulsive disorder (OCD) during the course of cognitive-behavioral therapy (CBT), as well as the association of sudden gains with treatment response, treatment group, and pre-treatment clinical characteristics. METHODS:The sample consisted of 136 youth (ages 7-17) with a primary diagnosis of OCD who were randomized in a double-blinded fashion to 10 sessions of CBT with augmentation of either d-cycloserine or placebo. Sudden gain status was determined based on clinician-rated obsessive-compulsive symptom severity, which was collected on 9 occasions across the study period. RESULTS:42.6% of youth experienced at least one sudden gain, which tended to occur either after starting exposure and response prevention or towards the end of treatment. After applying the Benjamini-Hochberg procedure for multiple comparisons, there were no significant pre-treatment predictors of sudden gains and only reduced insight predicted the reversal of gains. Individuals with at least one sudden gain had improved overall treatment outcomes, measured both by reduction in OCD symptom severity, and by global illness severity. LIMITATIONS:Several clinical constructs were not examined. Symptomatology was not assessed at every treatment session. Differences in those who achieved sudden gains and those who did not may be obscured. There is the possibility that a sudden gain reflected a scoring error generated by an optimistic or inaccurate report. Finally, a relatively homogenous sample may limit the generalizability of results. CONCLUSIONS:The course of CBT for pediatric OCD is variable with many children experiencing sudden gains, but a sizable percentage experience a reversal of gains which was related to reduced insight. Sudden gains tended to occur after starting exposure and response prevention and towards the end of treatment. TRIALSREGISTRATION:ClinicaltrialsgovRegistry:NCT00864123. https://www.clinicaltrials.gov/ct2/show/NCT00864123.

Project description:BackgroundTinnitus is the perception of sound without an external auditive stimulus and can be a severe burden for affected patients. Medical guidelines recommend cognitive behavioral therapy (CBT) for tinnitus treatment, which effectively improves tinnitus-related distress and anxiety.ObjectiveThis study investigates the outcome of a 9-month smartphone-based CBT for patients with tinnitus.MethodsThe randomized controlled clinical trial in this study investigates the efficacy of a smartphone-based CBT for 187 patients with chronic tinnitus over a 9-month treatment period. In the initial 3 months, a waiting list design was applied, and in the subsequent study phase, the data of both treatment groups were collectively analyzed. The scores on the Tinnitus Questionnaire (TQ); 9-item Patient Health Questionnaire (PHQ-9); 9-item Self-Efficacy, Optimism, Pessimism (SWOP-K9) questionnaire; and 20-item Perceived Stress Questionnaire (PSQ-20) were assessed as endpoints after 3 and 9 months of treatment.ResultsWe observed a statistically significant reduction in the tinnitus burden in patients who received the smartphone-based CBT intervention. Although no changes were observed initially in the TQ sum scores in the waiting control group (baseline mean, 37.8, SD 4.7; 3 months mean 37.5, SD 4.8; analysis of covariance [ANCOVA] P=.52), the scores significantly decreased once the app-based CBT had commenced. Data pooled from both groups revealed significant reduction in the TQ sum score by 12.49 (SD 1.44) (ANCOVA, P<.001) and 18.48 (SD 1.85) (ANCOVA, P<.001) points after 3 and 9 months, respectively, which was also clinically important. The calculated Cohen d was 1.38. Similarly, the scores on PSQ-20 (-9.14 points; ANCOVA, P<.001), PHQ-9 (-2.47 points; ANCOVA, P<.001), and SWOP-K9 (0.17 points; ANCOVA, P<.001) were significantly improved at the end of the therapy, with corresponding intermediate effect sizes after 9 months.ConclusionsThe data in our study provide evidence of statistically significant, clinically relevant, and continuous benefits of an app-based CBT intervention in patients with chronic tinnitus.Trial registrationDeutsches Register Klinischer Studien DRKS00022973; https://drks.de/search/de/trial/DRKS00022973.

Dataset Information

Trajectory of Improvement in Children and Adolescents With Chronic Migraine: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial.

Perspective

Trial registration

Publications

Trajectory of Improvement in Children and Adolescents With Chronic Migraine: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial.

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