90 Participants Needed

Cognitive Behavioral Therapy for Childhood Nightmares

Recruiting at 1 trial location
LP
Overseen ByLauren Prince, BA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to assess the efficacy of CBT-NC intervention to determine its impact on mental health and suicidality in children ages 6-17. The main aims are: Aim 1: Examine CBT-NC efficacy for improving nightmare distress and frequency in youth with chronic nightmares by comparing the treatment and waitlist group. Aim 2: Examine whether improvements in nightmares relate to fewer mental health problems for youth by determining by comparing the treatment and waitlist group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but children on prescribed psychotropic medications must be stable for 30 days before enrolling.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Nightmares in Children?

Research shows that Imagery Rehearsal Therapy (IRT), a component of Cognitive Behavioral Therapy for Nightmares, can reduce the frequency and distress of nightmares in children. Studies have found that children who participated in IRT experienced fewer nightmares and less anxiety related to their dreams.12345

Is Cognitive Behavioral Therapy for Nightmares safe for children?

Research on Imagery Rehearsal Therapy (IRT), a type of Cognitive Behavioral Therapy for Nightmares, shows it can be used safely in both children and adults, including those with serious mental illnesses, without any reported adverse reactions.12678

How is Cognitive Behavioral Therapy for Nightmares in Children different from other treatments for childhood nightmares?

Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC), particularly using Imagery Rehearsal Therapy (IRT), is unique because it involves children actively changing the storyline of their nightmares to reduce their frequency and distress. This approach is different from other treatments as it empowers children to use their imagination to alter the nightmare, which can lead to long-lasting improvements in their sleep and anxiety levels.12369

Research Team

LC

Lisa Cromer, PhD

Principal Investigator

University of Tulsa

TB

Tara Buck, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for children aged 6-17 who experience frequent nightmares and are not at immediate risk of self-harm. They must be stable on any psychotropic medications for 30 days, speak English at a minimum 6-year-old level, have a guardian to accompany them, and access to WIFI/data with a camera-enabled device.

Inclusion Criteria

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
My child can speak and understand English like a 6-year-old or better.
See 3 more

Exclusion Criteria

Children who have trouble understanding or speaking at the level of a 6-year-old or younger.
My child's sleep apnea is not effectively managed.
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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC) over five sessions

5 weeks
5 visits (in-person)

Follow-up

Participants are monitored for changes in mental health and suicidality after treatment

4 weeks
Weekly assessments

Waitlist Control

Participants in the waitlist control group complete assessments without receiving treatment and are offered treatment after the waitlist period

20 weeks

Treatment Details

Interventions

  • Cognitive Behavioral Therapy for Nightmares in Children
Trial Overview The study tests if Cognitive-Behavioral Therapy specifically designed for Nightmares in Children (CBT-NC) can reduce the distress and frequency of nightmares. It also looks at whether this reduction improves overall mental health. Participants will either receive the therapy or be placed on a waitlist as part of the study's design.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Right-AwayExperimental Treatment1 Intervention
Child will start the CBT-NC treatment right away.
Group II: Waitlist ControlActive Control1 Intervention
Waitlist control group will complete the assessments at the same time as the treatment group, without receiving any treatment. They will be offered treatment after finishing the waitlist.

Cognitive Behavioral Therapy for Nightmares in Children is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as CBT-NC for:
  • Chronic nightmares in children
  • Nightmare distress
  • Mental health problems in youth
🇪🇺
Approved in European Union as CBT-NC for:
  • Chronic nightmares in children
  • Nightmare distress
  • Mental health problems in youth

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

University of Tulsa

Collaborator

Trials
16
Recruited
5,100+

Findings from Research

Imagery rehearsal therapy (IRT) significantly reduced the frequency of nightmares in children aged 9 to 11, with a treatment group showing a notable decrease compared to a waiting-list group over a 9-month follow-up.
While IRT effectively decreased nightmare occurrences, it did not significantly reduce the distress associated with nightmares, indicating that further research is needed to explore its full potential and effects.
Imagery rehearsal therapy for frequent nightmares in children.St-Onge, M., Mercier, P., De Koninck, J.[2019]
Imagery Rehearsal Therapy (IRT) and exposure techniques significantly reduced nightmare frequency and distress, as well as improved sleep quality, anxiety, and depression in a study of 399 participants over 6 weeks.
Both IRT and exposure were found to be equally effective, suggesting that exposure to nightmare imagery may be a key therapeutic factor, while keeping a diary also provided some benefits compared to a waiting list.
Cognitive-behavioral self-help treatment for nightmares: a randomized controlled trial.Lancee, J., Spoormaker, VI., van den Bout, J.[2019]
A psychotherapeutic treatment adapted from imagery rehearsal therapy for children aged 6 to 11 showed significant reductions in the frequency of unpleasant dreams, nightmare distress, and manifest anxiety after an 8-week, 3-session protocol involving 10 child-mother dyads.
Follow-up assessments at 3 and 6 months post-treatment indicated that the positive effects of the intervention were maintained, highlighting its potential long-term benefits for managing nightmares in children.
Adaptation of imagery rehearsal therapy for nightmares in children: A brief report.Simard, V., Nielsen, T.[2011]

References

Imagery rehearsal therapy for frequent nightmares in children. [2019]
Cognitive-behavioral self-help treatment for nightmares: a randomized controlled trial. [2019]
Adaptation of imagery rehearsal therapy for nightmares in children: A brief report. [2011]
Effectiveness of imagery rehearsal therapy for the treatment of combat-related nightmares in veterans. [2019]
Imagery rehearsal therapy in addition to treatment as usual for patients with diverse psychiatric diagnoses suffering from nightmares: a randomized controlled trial. [2019]
Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. [2019]
Treatment of Nightmares in Psychiatric Inpatients With Imagery Rehearsal Therapy: An Open Trial and Case Series. [2020]
A systematic review of cognitive-behavioral treatment for nightmares: toward a well-established treatment. [2019]
Clinical management of chronic nightmares: imagery rehearsal therapy. [2019]
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