Cognitive Behavioral Therapy for Insomnia and Nightmares

(RESTED Trial)

Overseen By Lily Jankowiak, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Schizophrenia, PTSD, Bipolar, Substance use, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cognitive behavioral therapy (CBT) can improve sleep issues and PTSD symptoms in individuals who have recently experienced violence. The study compares two groups: one receiving CBT focused on insomnia and nightmares, and another receiving general sleep education enhanced with nightmare education. Participants will attend six weekly telehealth sessions and report changes in their symptoms. Individuals treated at Henry Ford Hospital after a violent incident in the last 72 hours, who are not currently in other CBT treatments, may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to understanding how CBT can benefit those with recent trauma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this therapy is safe for treating posttraumatic sleep disturbance?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) safely treats sleep problems. Studies have found it to be a non-drug treatment that improves sleep without the side effects often associated with sleeping pills. People generally tolerate CBT-I well without major issues.

One study highlighted that CBT-I is particularly beneficial for those with nightmares, suggesting it can effectively reduce symptoms without causing harm. Health care professionals recommend this therapy to improve sleep and potentially lower the risk of suicidal thoughts.

Overall, CBT-I is considered a safe and effective treatment for insomnia and nightmares, making it a good choice for those seeking to improve their sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy (CBT) for Insomnia and Nightmares because it directly targets and modifies unhelpful thoughts and behaviors, setting it apart from standard treatments like medication. Unlike typical sleep medications that often focus on symptoms and may have side effects, CBT addresses the root causes of sleep issues, offering a long-term solution. Additionally, the therapy empowers individuals with skills and strategies to manage insomnia and nightmares, promoting lasting improvements in sleep quality.

What evidence suggests that this trial's treatments could be effective for posttraumatic sleep disturbance?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I), which participants in this trial may receive, helps improve sleep and reduces insomnia symptoms. Most individuals who try CBT-I report better sleep. In this trial, some participants will receive CBT-I combined with special therapy for nightmares (CBT-I&N), which can decrease the frequency of nightmares and enhance overall sleep quality. Studies suggest that CBT-I&N might also help reduce post-traumatic stress symptoms. These therapies are available through telehealth, providing easy and convenient access. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for acute trauma patients who have experienced interpersonal violence and are now dealing with sleep disturbances like insomnia or nightmares, possibly related to PTSD. Participants should be comfortable using telehealth services.

Inclusion Criteria

Fluent in English

Hospital Mental Health Risk Screen score ≥ 10

I experienced a significant injury within the last 3 days.

Exclusion Criteria

Pregnant

I do not have uncontrolled mania or bipolar disorder.

Current or past PTSD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Treatment

Participants receive cognitive behavioral therapy for insomnia and nightmares via telehealth

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in insomnia and PTSD symptoms after treatment

3 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia and Nightmares
• Sleep Education enhanced with Nightmare Education

Trial Overview The study tests the effectiveness of virtual cognitive behavioral therapy (CBT) specifically designed for insomnia and nightmares as an early treatment after trauma. It compares CBT for just insomnia (CBT-I), CBT for both issues (CBT-I&N), against a control group receiving only sleep education.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy Experimental Treatment 2 Interventions

Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors.

Group II: Sleep Education Active Control 2 Interventions

Sleep Education provides general information on human sleep and sleep hygiene guidelines.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9303051/

Cognitive behavioral therapy-based treatments for ... ... nightmares: Effects on nightmare frequency, sleep quality, and posttraumatic stress. Clinical Psychology Review. 2012;32(6):566–574. doi ...

2. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11756

main outcomes of a randomized dismantling trial The protocol directors were the monitoring entity. Criteria for discontinuation was an increase in bothersome nightmares for a week under ...

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000107

Cognitive behavioral therapy for insomnia in patients with ... Several studies included add-on components in addition to CBT-I. These were imagery rehearsal therapy for nightmares [41,42], rise routines and light therapy [ ...

5. sleepfoundation.org sleepfoundation.org/insomnia/treatment/cognitive-behavioral-therapy-insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) Most individuals who try CBT-I experience improvements to their insomnia and better quality sleep. CBT-I is considered effective for both short- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10620662/

Cognitive behavioral therapy for insomnia treatment ... This study's objective was to evaluate the effect of nightmares (NMs) on attrition and symptom change following cognitive behavioral therapy for insomnia (CBT-I) ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000084

The effect and safety of sleep interventions on suicidal ... Health care professionals are recommended to apply psychotherapeutic sleep interventions, such as cognitive behavioral therapy for insomnia, to reduce suicidal ...

8. mayoclinic.org mayoclinic.org/diseases-conditions/insomnia/in-depth/insomnia-treatment/art-20046677

Cognitive behavioral therapy instead of sleeping pills Cognitive behavioral therapy, sometimes called CBT, can effectively treat long-term sleep problems like insomnia. Generally, it's the first treatment ...

9. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1649937.pdf

Cognitive Behavioral Therapy for Insomnia With Prolonged ... This study compared the efficacy of integrated cognitive behavioral therapy for insomnia (CBT-I) and prolonged exposure (PE; CBTI-PE) therapy to ...