NCT05588739: COMAA

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

Completed NA Last updated 22 June 2023

What this trial tests

NA trial testing Cognitive Behavioral Therapy in Nightmare in 58 participants. Completed in 16 June 2023.

Timeline

30 September 2020

Primary endpoint
16 June 2023

16 June 2023

Quick facts

Lead sponsor	University of Oklahoma
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	58
Start date	30 September 2020
Primary completion	16 June 2023
Estimated completion	16 June 2023
Sites	2 locations across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy

Conditions studied

• Nightmare — all drugs for Nightmare →

Sponsor

University of Oklahoma

Who can join

Adults 6 to 17, any sex, with Nightmare. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of a telehealth cognitive behavioral therapy for improving sleep and nightmares in children aged 6-17.
   Cromer LD, Bell SB, Prince LE, Hollman N, et al · · 2024 · cited 1× · PMID 41424486 · DOI 10.3389/frsle.2024.1401023