Cognitive Behavioral Therapy for Childhood Nightmares

Recruiting at 1 trial location

Overseen By Lauren Prince, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Sleep apnea, Language skills, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC) to determine if it reduces nightmare distress and frequency in children with chronic nightmares. Researchers aim to discover whether fewer nightmares improve overall mental health in these children. Participants will either begin therapy immediately or join a waitlist for comparison. The trial seeks children aged 6-17 who experience recurring nightmares and can speak and understand English at a 6-year-old level. Participants need a stable internet connection and a device with a camera for study visits. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving mental health treatments for children.

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 prior data suggests that Cognitive Behavioral Therapy for Nightmares in Children is safe?

Research has shown that Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC) is generally safe for young participants. In past studies, this therapy improved sleep and reduced the frequency of nightmares without causing significant side effects. The therapy includes structured sessions where children learn to manage their nightmares using techniques like imagery rehearsal, which involves practicing new, positive endings for their dreams.

While not every therapy works for every child, CBT-NC has been well-received overall. No evidence suggests major safety concerns or harmful side effects. Since this therapy does not involve medication and uses psychological techniques, it is considered low-risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Nightmares in Children because it offers a tailored, psychological approach specifically targeting nightmares, unlike standard treatments that might focus on broader sleep disorders or utilize medication. This therapy helps children address the root causes of their nightmares and equips them with coping skills, potentially providing long-lasting relief without the side effects associated with medications. Additionally, it empowers children by involving them actively in the therapeutic process, making it a unique and promising option compared to conventional treatments.

What evidence suggests that Cognitive Behavioral Therapy for Nightmares in Children is effective for improving nightmare distress and frequency?

Research has shown that Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC) is a promising method to reduce the frequency and distress of nightmares in children. In this trial, some children will begin CBT-NC immediately, while others will join a waitlist control group. Case studies have found that this therapy is effective for children, regardless of trauma history. Additionally, studies combining CBT with specialized techniques for nightmares, such as Imagery Rehearsal Therapy, have demonstrated positive outcomes when nightmares are the primary concern. These findings suggest that CBT-NC can improve children's sleep and may also alleviate other mental health issues related to frequent nightmares. ^{1 3 6 7 8}

Who Is on the Research Team?

Lisa Cromer, PhD

Principal Investigator

University of Tulsa

Tara Buck, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Treatment Right-Away Experimental Treatment 1 Intervention

Child will start the CBT-NC treatment right away.

Group II: Waitlist Control Active Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imagery rehearsal therapy for frequent nightmares in children. St-Onge, M., Mercier, P., De Koninck, J.[2019]

Chronic nightmares affect a significant number of trauma survivors and about 5% to 8% of the general population, indicating that they may be a primary sleep disorder rather than just a symptom of other psychiatric issues.

Imagery Rehearsal Therapy (IRT) is the most supported treatment for nightmares, involving four 2-hour sessions that focus on cognitive-imagery techniques, with suggestions for dismantling protocols to tailor the therapy to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of chronic nightmares: imagery rehearsal therapy. Krakow, B., Zadra, A.[2019]

Cognitive Behavioral Therapy (CBT) is effective in reducing nightmare frequency, with significant improvements observed in all studies reviewed, indicating its potential as a non-pharmacological treatment for nightmares.

Among the various CBT techniques, nightmare-focused interventions like Imagery Rehearsal Therapy (IRT) showed better outcomes compared to indirect methods, suggesting that targeted approaches may be more effective, although further research is needed to directly compare these techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of cognitive-behavioral treatment for nightmares: toward a well-established treatment. Lancee, J., Spoormaker, VI., Krakow, B., et al.[2019]

Imagery Rehearsal Therapy (IRT) significantly reduces nightmare frequency and distress in a psychiatric population, showing a moderate effect size (Cohen d = 0.5-0.7) compared to standard treatment over a period of 6 sessions.

The benefits of IRT were largely maintained at a 3-month follow-up, indicating its effectiveness as a complementary treatment for patients with psychiatric disorders experiencing nightmares.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imagery rehearsal therapy in addition to treatment as usual for patients with diverse psychiatric diagnoses suffering from nightmares: a randomized controlled trial. van Schagen, AM., Lancee, J., de Groot, IW., et al.[2019]

Imagery Rehearsal Therapy (IRT) was found to significantly reduce the frequency and intensity of nightmares in a study involving 20 adult psychiatric inpatients over 3 weeks, alongside improvements in overall sleep and other symptoms like suicidal ideation.

No adverse reactions were reported, suggesting that IRT can be safely integrated into treatment for patients with serious mental illnesses, although further controlled studies are needed to confirm its specific efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Nightmares in Psychiatric Inpatients With Imagery Rehearsal Therapy: An Open Trial and Case Series. Ellis, TE., Rufino, KA., Nadorff, MR.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of imagery rehearsal therapy for nightmares in children: A brief report. Simard, V., Nielsen, T.[2011]

In a randomized controlled trial with 104 patients suffering from nightmare disorder, both imagery rescripting (IR) and imaginal exposure (IE) significantly reduced nightmare frequency and distress compared to a wait-list control group.

The positive effects of both treatments were not only immediate but also sustained over 3- and 6-month follow-ups, suggesting that IR and IE are effective components of cognitive-behavioral therapies for nightmares.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. Kunze, AE., Arntz, A., Morina, N., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral self-help treatment for nightmares: a randomized controlled trial. Lancee, J., Spoormaker, VI., van den Bout, J.[2019]

Imagery Rehearsal Therapy (IRT) has been found to significantly reduce the frequency and intensity of nightmares, as well as improve insomnia and daytime PTSD symptoms in veterans, based on a chart review of those seeking outpatient treatment.

After completing IRT, 23% of veterans experienced a complete response with fewer than one nightmare per week, and their insomnia and PTSD symptoms fell below clinical cutoffs, indicating IRT's potential as an effective short-term treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of imagery rehearsal therapy for the treatment of combat-related nightmares in veterans. Nappi, CM., Drummond, SP., Thorp, SR., et al.[2019]

Citations

1. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2024.1401023/full

Efficacy of a telehealth cognitive behavioral therapy for ... However, there is also evidence that CBT-I alone does not improve nightmares, and there is a pressing need for nightmare-specific treatment ...

2. researchgate.net researchgate.net/publication/359736705_Case_Study_of_Cognitive_Behavioral_Therapy_for_Nightmares_in_Children_With_and_Without_Trauma_History

(PDF) Case Study of Cognitive Behavioral Therapy for ... Findings demonstrate that this adapted nightmare treatment for children is feasible and promising for nightmares in children, regardless of nightmare etiology.

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15346501221081122

Case Study of Cognitive Behavioral Therapy for ... Findings demonstrate that this adapted nightmare treatment for children is feasible and promising for nightmares in children, regardless of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30070398/

Efficacy of Imagery Rehearsal Therapy and Cognitive ... In this study, we evaluated the efficacy of a combination of CBT and nightmare ... nightmares are the primary complaint. Trial registration ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06033781

Cognitive-Behavioral Therapy for Children With Nightmares Aim 1: Examine CBT-NC efficacy for improving nightmare distress and frequency in youth with chronic nightmares by comparing the treatment and waitlist group.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4120639/

A Meta-analysis of Imagery Rehearsal for Post-trauma ... This meta-analysis evaluates the efficacy of imagery rehearsal as a treatment for nightmares, general sleep disturbance, and symptoms of post-traumatic stress.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9013762/

Nightmare Rescripting: Using Imagery Techniques to Treat ... At the end of the study, the women assigned to the cognitive imagery treatment group showed significantly fewer nightmares per week and better sleep quality ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0960982222014774

Enhancing imagery rehearsal therapy for nightmares with ... Although IRT appears to be effective in the management of nightmares, approximately 30% of patients are unresponsive to this treatment.