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Treatment Right-Away for Nightmares (COMAA Trial)

N/A

Waitlist Available

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants 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).

Awards & highlights

COMAA Trial Summary

This trial seeks to determine if reducing chronic nightmares can help lower suicide risk in children & teens, which has risen 56% in the last decade.

Eligible Conditions

Nightmares

COMAA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants 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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in reports on Sleep Journal

Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)

Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)

+5 more

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

COMAA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Right-AwayExperimental Treatment1 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 ControlActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy

2016

Completed Phase 4

~3120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of TulsaOTHER

15 Previous Clinical Trials

10,767 Total Patients Enrolled

5 Trials studying Nightmares

237 Patients Enrolled for Nightmares

University of OklahomaLead Sponsor

455 Previous Clinical Trials

97,552 Total Patients Enrolled

2 Trials studying Nightmares

114 Patients Enrolled for Nightmares

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment slots still available for this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this clinical trial is currently enlisting participants and was initially posted on September 30th 2020. The last edit occurred on October 18th 2022 and the study necessitates 30 patients from 2 individual sites."

Answered by AI

Who is eligible to participate in this clinical research?

"Patients aged between 6 and 17 years old who suffer from night terrors may be eligible to join this clinical trial, with up to 30 patients being accepted."

Answered by AI

Does this study extend to individuals who have reached the age of 85 or beyond?

"This trial has a wide age range for enrollment, accepting participants aged 6 to 17."

Answered by AI

How many participants are currently contributing to this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial originally posted on September 30th 2020 is still actively seeking participants. The study requires a total of 30 patients from two separate research locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05588739.