Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA)

NCT ID: NCT05588739

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2023-06-16

Brief Summary

Youth suicide risk has increased 56% in the last decade, and suicide is the leading cause of preventable death in children and adolescents. Experiencing chronic nightmares doubles the risk of suicidal ideation in children and adolescents. Decades of research support that even when controlling for depression and insomnia, nightmares predict suicidality. Contemporary theories model nightmares as the mediating link between depression and suicide. Numerous studies examine the effect of nightmare-specific therapies on reducing suicide in adults, but none have examined whether nightmare therapies can reduce youth suicidality. The proposed pilot will evaluate the feasibility of the Cognitive Behavioral Therapy for Nightmares in Children paradigm (CBT-NC), recruiting and retaining children ages 6-17 who experience chronic nightmares. Utilizing a waitlist control (WL) model, participants (n=30) will be randomized after baseline assessment to either immediate treatment or a WL. Feasibility will be evaluated by examining retention through treatment (or WL) to post WL and post treatment assessments. Both groups will be evaluated before and after the treatment for suicidal ideation, sleep quality, and nightmare distress and frequency, in order to document improvements due to therapy. The proposed pilot will provide preliminary data about recruitment, retention, and allow for effect size calculations between groups. These results will be used to develop a larger treatment study that would ultimately evaluate the mediating effect of treatment for chronic nightmares on suicidality in children.

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, relaxation, 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 session 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 session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Child must be between the ages of 6-17 years 11 months.
• Child must report recurrent nightmares that meet DSM criteria for nightmare disorder.
• Child must speak and understand English at no less than a 6 year old level.
• Children on prescribed psychotropic medications must be stable for 30 days prior to enrolling.
• Child must have a parent or legal guardian attend study visits with them.
• Participants must have access to WIFI/phone data in order to participate in this study, and must have an electronic device with a camera enabled. Our study team will have the capability of driving a tablet to the participant's home if that is the only reason they cannot participate, and if the family lives within the greater Tulsa area.

Exclusion Criteria

• Children with a previous diagnosis of sleep apnea which is not adequately treated.
• Children whose receptive/expressive language skills are below a 6 year old level.
• If it is determined that a child is actively suicidal and at imminent risk for self-harm, the family will be notified and referred for immediate care. They will not be eligible for the study until they are deemed stable.

• Minimum Eligible Age: 6 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

Locations

University of Tulsa

Tulsa, Oklahoma, United States

University of Oklahoma School of Community Medicine

Tulsa, Oklahoma, United States

Countries

United States

Other Identifiers

IRB12343

Identifier Type: -

Identifier Source: org_study_id