Cognitive Behavioral Therapy for Nightmares in Children

NCT ID: NCT04047277

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-22
• Study Completion Date: 2020-10-30

Brief Summary

Up to 50% of children experience nightmares annually. Nightmares interfere with sleep quality and quantity resulting in sleep deficiency, and are associated with negative mental health consequences. Previous research has shown efficacy of manualized CBT treatment for reducing trauma related nightmares in adults, and preliminary evidence has shown efficacy in children. This study is the first randomized clinical trial to evaluate the effectiveness of the treatment for idiopathic, as well as trauma related nightmares in children. The treatment in a manualized CBT protocol (5 sessions) that teaches sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.

Conditions

Nightmare

Study Design

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

Study Groups

Treatment Right-Away

Cognitive Behavioral Therapy using exposure, relaxztion, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

The manualized CBT protocol is five sessions that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.

Waitlist Control

Waitlist control group will complete pre and post assessments at beginning and end of wait period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy

The manualized CBT protocol is five sessions that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children must have a history of nightmares occurring approximately once or more per week over a minimum of one month.
• Children must have verbal comprehension of at least age 5 (determined by PPVT), and be fluent in English.
• If taking psychotropic medications, must be stable for one month.
• Children must have a parent or legal guardian who is able to participate in treatment assignments and be able to read and speak English.

Exclusion Criteria

• Under age 5 or over age 17.
• No nightmares (or less than averaging one per week)
• Apparent psychosis
• Pervasive developmental disorder or mental retardation
• Not able to read and speak English.
• Sleep apnea

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tulsa

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa M Cromer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tulsa

Tara R Buck, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma School of Community Medicine

Locations

University of Tulsa

Tulsa, Oklahoma, United States

University of Oklahoma School of Community Medicine

Tulsa, Oklahoma, United States

Countries

United States

Other Identifiers

IRB9653

Identifier Type: -

Identifier Source: org_study_id