NightmareCOMAANCT05588739
Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA)
A study testing Cognitive Behavioral Therapy in people with Nightmare, run by University of Oklahoma at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Nightmare
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2020to 16 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Tulsa
Tulsa, Oklahoma, 74104
University of Oklahoma School of Community Medicine
Tulsa, Oklahoma, 74135
About this study
Official title: Evaluating the Feasibility of a Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk
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
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Nightmares, Children, Trauma, CBT, Exposure, Relaxation, Rescripting, Cognitive, Behavioral, Therapy, Suicidality
- Medical subject headings
- Wounds and Injuries, Behavior, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
The manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Right-Away | Experimental | Cognitive Behavioral Therapy using exposure, relaxation, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring. Receives: Behavioral: Cognitive Behavioral Therapy |
| Waitlist Control | No intervention | Waitlist control group will complete pre and post assessments at beginning and end of wait period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Measured: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)
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.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Change on Sleep Locus of Control (SLOC)
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.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Change on Nightmare Locus of Control (NLOC)
The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Change in reports on Sleep Journal
6 question self report that patient assesses daily from home.
Measured: 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).
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Measured: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)
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.
Measured: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
The CES-DC is a 20-item self-report depression inventory. A score of 15 or higher indicates significant levels of depression.
Measured: Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start30 Sep 2020
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NightmareStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tulsa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588739
- Sponsor's protocol ID
- IRB12343
- Acronym
- COMAA
- Status last verified
- Jun 2023
- First submitted
- 3 Oct 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cromer LD, Bell SB, Prince LE, Hollman N, El Sabbagh E, Buck TR. Efficacy of a telehealth cognitive behavioral therapy for improving sleep and nightmares in children aged 6-17. Front Sleep. 2024 Jul 11;3:1401023. doi: 10.3389/frsle.2024.1401023. eCollection 2024.
PubMed 41424486
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk
- ClinicalTrials.gov ID
- NCT05588739
- Acronym / sponsor ID
- COMAA / IRB12343
- Conditions
- Nightmare
- Keywords
- Nightmares, Children, Trauma, CBT, Exposure, Relaxation, Rescripting, Cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- University of Tulsa
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Right-Away | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy using exposure, relaxation, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring. |
| Waitlist Control | No intervention | –Waitlist control group will complete pre and post assessments at beginning and end of wait period. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyThe manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting. | Behavioural | Treatment Right-Away |
Primary outcome
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
Time frame: Participants 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Journal
Time frame: 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).
6 question self report that patient assesses daily from home.
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
Time frame: Participants 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)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 41424486Cromer LD, Bell SB, Prince LE, Hollman N, El Sabbagh E, Buck TR. Efficacy of a telehealth cognitive behavioral therapy for improving sleep and nightmares in children aged 6-17. Front Sleep. 2024 Jul 11;3:1401023. doi: 10.3389/frsle.2024.1401023. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Nightmare
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Restorative Early Sleep Treatment After the Emergency Department
Insomnia, Nightmares Associated With Trauma and Stress
Recruiting
NightWare and Cardiovascular Health in Veterans With PTSD
Post-traumatic Stress Disorder (PTSD), Cardiovascular Diseases
Active, not recruitingPhase 2
Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Nightmare
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Nightmare, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the Child Adolescent Trauma Screen (CATS) - Child Version (time frame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05588739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.