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

Evaluating the Feasibility of a Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05588739
Acronym
COMAA
Enrollment
58
Registered
2022-10-20
Start date
2020-09-30
Completion date
2023-06-16
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nightmare

Keywords

Nightmares, Children, Trauma, CBT, Exposure, Relaxation, Rescripting, Cognitive, Behavioral, Therapy, Suicidality

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

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

Sponsors

University of Tulsa
CollaboratorOTHER
University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Blinded randomization into 2 groups: Treatment & Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after a 5 week wait.

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change on the Child Adolescent Trauma Screen (CATS) - Child VersionParticipants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.The TRNS-C is a 14 item self report questionnaire that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children.
Change on Sleep Locus of Control (SLOC)Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.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.
Change on Nightmare Locus of Control (NLOC)Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.
Change in reports on Sleep JournalParticipants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase (an average of 5 weeks), at Post treatment (for 1 week).6 question self report that patient assesses daily from home.
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding childParticipants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.The DBAS-16 is a 16-item self-report measure that evaluates the role of sleep related beliefs. The score is a sum of the 16 items, ranging from 16 to 80. Higher scores represent more dysfunctional beliefs about sleep.
Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).The CES-DC is a 20-item self-report depression inventory. A score of 15 or higher indicates significant levels of depression.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026