Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC)

Clinical Outcomes of Cognitive Behavioral Therapy for Nightmares in Children

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.

Study Overview

• Status: Completed
• Conditions: Nightmare
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • University of Oklahoma School of Community Medicine
    • Tulsa, Oklahoma, United States, 74104
      • University of Tulsa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control; Waitlist control group will complete pre and post assessments at beginning and end of wait period.
Experimental: Treatment Right-Away; Cognitive Behavioral Therapy using exposure, relaxztion, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.	Behavioral: Cognitive Behavioral Therapy; The manualized CBT protocol is five sessions that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on the Child Adolescent Trauma Screen (CATS) - Child Version	The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Trauma Related Nightmare Survey (TRNS-C) - Child Version	The TRNS-C is a 14 item self report measure that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children.	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Nightmare Distress Questionnaire (NDQ)	The NDQ is a 13 item self report measure of nightmare related distress. Higher scores are significantly related to interest in therapy for nightmares.	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Nightmare Locus of Control (NLOC)	The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Pittsburgh Sleep Quality Index - Modified (PSQI) - Child Version	The PSQI-M is a 10 item (with 2 items containing 23 sub items) self report measure of sleep quality and disturbance. It queries sleep quality and disturbances over the last month.	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Children's Report of Sleep Patterns (CRSP)	The CRSP is a 62 item self report measure of children's sleep patterns, sleep hygiene, and sleep disturbances for children eight to 12 years of age	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Sleep Locus of Control (SLOC)	The SLOC is an 6 item self report measure perceived contingencies between sleep behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Epworth Sleepiness Scale (ESS)	The ESS is an 8 item self report. The test is a list of eight situations in which one rates his/her tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When the test is finished, response values are added up. The total score is based on a scale of 0 to 24. The scale estimates whether one is experiencing excessive sleepiness that possibly requires medical attention.	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change in reports on Sleep Journal	6 question self report that patient assesses daily from home.	Participants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase, at Post treatment (for 1 week), at 3 month follow-up (for 1 week), and at 6 month follow-up (for 1 week).
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child	The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Change on the Children's Sleep Habits - Caregiver Report regarding child	To examine sleep habits and possible difficulties with sleep in preschool and school-aged children	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Adverse Childhood Experiences for CHILD - Caregiver Report regarding child	Assesses adverse experiences from infancy through early childhood	approximately 3 years.
Change on the Sleep Disturbances Scale for Children - Caregiver Report regarding child	SDSC is a 26-item inventory rated on a 5 point Likert-type scale. The instrument's purpose is to categorize sleep disorders in children	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on the Parental Stress Scale	18 item self report scale used for the assessment of parental stress for both mothers and fathers and for parents of children with and without clinical problems. • 5 - Point scale; strongly disagree, disagree, undecided, agree, strongly agree. A low score signifies a low level of stress, and a high score to signifies a high level of stress.	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Adverse Childhood Experiences for SELF - Caregiver Report regarding self	Assesses adverse experiences from infancy through early childhood	approximately 3 years.

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: University of Tulsa
• Investigators: Principal Investigator: Lisa M Cromer, PhD, University of Tulsa; Principal Investigator: Tara R Buck, MD, University of Oklahoma School of Community Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Children; Relaxation; Therapy; CBT; Trauma; Cognitive; Nightmares; Exposure; Rescripting; Behavioral
• Other Study ID Numbers: IRB9653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No