A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety

NCT ID: NCT01182051

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-06-30

Brief Summary

The primary aim of this proposal is to refine the intervention under investigation (i.e., family-based CBT) and evaluate the feasibility and acceptability of the intervention and methods (e.g., recruitment, assessments).

The secondary aim of this proposal is to compare the relative efficacy of an 8 session family-based cognitive-behavioral therapy (CBT) to Relaxation Training (RT) for reducing anxiety and chronic headaches in youth (N = 30) ages 7-17 years. It is hypothesized that CBT will result in greater reductions in both anxiety and headache frequency and severity compared to RT.

Detailed Description

Chronic daily headache in children, as well as periodic migraine, is a prevalent, persistent, and debilitating pain condition affecting nearly 1 in 10 children. Emerging evidence suggests that affected youth also experience excessive and impairing symptoms of anxiety which may play a role in the etiology and/or maintenance of headache pain. Current behavioral treatments are effective in reducing headache frequency and intensity, however, many youth remain symptomatic and the exacerbating role of anxiety has largely been ignored. Moreover, current psychosocial treatments fail to incorporate parents in the therapeutic process. The current proposal is a pilot study designed to address the shortcomings of current behavioral treatments by evaluating the initial efficacy of a family-based cognitive-behavioral therapy (CBT) for youth who present with chronic tension headaches and migraines, and excessive anxiety. Rigorous scientific methods will be employed, including a randomized design, multiple informants and measures to assess key constructs, independent evaluators (IEs) to assess outcomes, and intensive training for therapists and IEs to assure a high quality of implementation. Using a pre-post experimental design, 30 youth with chronic tension headaches and/or migraines and anxiety will be randomly assigned to receive 8 weeks of family-based CBT or relaxation training (RT). IEs will complete assessments of child symptoms and functioning at pre and post-treatment and at one month follow-up. Youth in the family-based CBT condition are expected to evince greater reductions in both headache and anxiety frequency, severity, and duration. Results from this study will be used to make empirically informed modifications to the CBT treatment manual in order to facilitate replication and dissemination of the interventions to clinicians and researchers.

Conditions

Pediatric; Headache; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive behavioral therapy

Key treatment ingredients in CBT include psychoeducation, trigger identification, progressive muscle relaxation training, cognitive restructuring, problem solving, in vivo exposure, and relapse prevention (see Appendix I for an outline of the treatment manual).

Group Type: EXPERIMENTAL

CBT or relaxation training

Intervention Type: BEHAVIORAL

8 weeks of CBT or relaxation training.

Relaxation Training

RT will consist of progressive muscle relaxation training, diaphragmatic breathing, and thermal biofeedback.

Group Type: ACTIVE_COMPARATOR

CBT or relaxation training

Intervention Type: BEHAVIORAL

8 weeks of CBT or relaxation training.

Interventions

CBT or relaxation training

8 weeks of CBT or relaxation training.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• To determine eligibility, youth will complete an evaluation consisting of clinical interviews, self-, and parent-report measures.
• To be included in the study, all children must:

1. have a current diagnosis of chronic daily headache, tension-type headache, and/or migraine headache

2. obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED) in the clinical range (i.e., > 20)

3. be between 7 and 17 years old

4. have a parent/guardian who gives consent and agrees to participate

5. be English speaking

6. not currently participating in other psychosocial treatments specifically directed at reducing head pain or anxiety.

• For youth receiving prophylactic medication, it is preferable that they remain on a stable dose and agree to avoid medication changes while enrolled in the study. Thus, all participants will be permitted to continue with their prescribed medical/neurological treatment, however the use of medications (both prophylactic and over-the-counter analgesics) will be closely monitored.

Exclusion Criteria

• Youth will be excluded from the study if they have a medical or psychiatric condition contraindicating study treatment or warranting an alternative intervention (e.g., suicidality, depression).

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Migraine Research Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Golda S. Ginsburg, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Golda S Ginsburg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA-00019444

Identifier Type: -

Identifier Source: org_study_id