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

NCT01182051 | Completed

• 1 other identifier: NA-00019444
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric; Headache; Anxiety

Keywords

headache; anxiety; pediatric headache and anxiety

Outcome Measures

Primary Outcomes (2)

• Daily Headache and Anxiety Diary

  Youth and parents will complete a daily headache and anxiety diary to track the frequency and severity of headaches and anxiety symptoms. In addition, the diary will assess medication use, missed school/activities, as well as antecedents and consequences.

  Daily for three months

• Pediatric Anxiety Rating Scale (PARS)

  The Pediatric Anxiety Rating Scale (PARS) will be completed by an independent evaluator to assess the severity of current (within the past week) anxiety symptoms in youth. The instrument consists of two sections. The first section contains a 50-item anxiety symptoms checklist. The second section assesses the severity and impairment of these symptoms. A total score is computed by summing the severity items. The measure has acceptable internal consistency, reliability, and convergent/divergent validity.

  2 months

Secondary Outcomes (3)

• Pediatric Migraine Disability Assessment (PedMIDAS)

  2 months

• Pediatric Migraine Disability Assessment (PedMIDAS)

  3 months

• Pediatric Anxiety Rating Scale (PARS)

  3 months

Study Arms (2)

Cognitive behavioral therapy

EXPERIMENTAL

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).

Behavioral: CBT or relaxation training

Relaxation Training

ACTIVE COMPARATOR

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

Behavioral: CBT or relaxation training

Interventions

CBT or relaxation training BEHAVIORAL

8 weeks of CBT or relaxation training.

Cognitive behavioral therapy; Relaxation Training

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• have a current diagnosis of chronic daily headache, tension-type headache, and/or migraine headache
• obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED) in the clinical range (i.e., \> 20)
• be between 7 and 17 years old
• have a parent/guardian who gives consent and agrees to participate
• be English speaking
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Migraine Research Foundation: collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Headache; Anxiety Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Golda S Ginsburg, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: August 16, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

US (1)