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

(COMAA Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Oklahoma

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

Child must have a parent or legal guardian attend study visits with them.

Child must be between the ages of 6-17 years 11 months.

Child must report recurrent nightmares that meet DSM criteria for nightmare disorder.

Treatment Details

Interventions

• Cognitive Behavioral Therapy (Behavioral Intervention)

Participant Groups

Group I: Treatment Right-Away Experimental Treatment 1 Intervention

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

Group II: Waitlist Control Active Control 1 Intervention

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

Cognitive Behavioral Therapy is already approved in Canada for the following indications:

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Oklahoma School of Community Medicine Tulsa, OK

University of Tulsa Tulsa, OK

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Patients Recruited

95,900+

University of Tulsa

Collaborator

Trials

16

Patients Recruited

5,100+