Cognitive Behavioural Therapy for Chronic Insomnia

Recruiting in Palo Alto (17 mi)

Overseen by Thanh Dang-Vu, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Concordia University, Montreal

Must not be taking: Antidepressants, Anxiolytics, Hypnosedatives

Disqualifiers: Neurological disorder, Cancer, Heart failure, Sleep apnea, Severe mental disorders, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Individuals with chronic insomnia have persistent difficulty falling and staying asleep, as well as complaints of altered daytime functioning that may be associated with cognitive impairments. The neural processes underlying these daytime complaints may involve abnormal activation of brain regions and neural networks involved in working memory, memory encoding and emotions. The goal of this study is to assess whether a psychological treatment for insomnia will reverse these abnormalities in brain responses to cognitive tasks and at rest. A secondary objective of the study is to characterize impairments in attentional processing and assess if the impairments can be reversed by the psychological treatment. We hypothesized that the psychological treatment for insomnia will lead to a normalization of the brain responses to working memory, declarative memory encoding, insomnia-related stimuli, and the functional connectivity within the default-mode and limbic networks.

Will I have to stop taking my current medications?

The trial requires participants to stop using hypnosedative medications (medications that help with sleep) for at least 2 weeks before the first assessment. If you are currently using medication for depression or anxiety, you may not be eligible to participate.

What data supports the effectiveness of the treatment Cognitive-Behavioural therapy for insomnia (CBT-I)?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for improving sleep quality and reducing the need for sleep medication in people with chronic insomnia. It is considered the first-choice treatment for both simple insomnia and insomnia that occurs alongside other chronic conditions. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe for humans and is recommended as a first-line treatment for chronic insomnia because it does not have the risks of tolerance or side effects that are often associated with medication. ^{2 3 4 6 7}

How is CBT-I different from other treatments for chronic insomnia?

CBT-I (Cognitive Behavioral Therapy for Insomnia) is unique because it is a non-drug treatment that focuses on changing sleep habits and thoughts about sleep, making it the first-line treatment for insomnia. Unlike medications, it addresses the root causes of insomnia and can be delivered in various formats like online sessions or workshops, though it requires trained professionals to administer. ^{1 2 4 7 8}

Research Team

Thanh Dang-Vu, MD PhD

Principal Investigator

Concordia University, Montreal

Eligibility Criteria

This trial is for adults aged 25-65 with chronic insomnia, experiencing persistent trouble sleeping and daytime issues. It's open to both those suffering from insomnia and good sleepers as controls. Exclusions include serious health conditions like heart failure, untreated thyroid disorders, severe mental disorders, recent major surgery or infections, substance abuse, and certain sleep-related disorders.

Inclusion Criteria

I have been diagnosed with chronic primary insomnia.

It seems like you provided a fragment of a criterion. Could you please provide more context or clarify the criterion so that I can assist you better?

Exclusion Criteria

You have worked night shifts or rotating shifts for more than 2 weeks in the last 3 months, or plan to do so during the study.

I have sleep apnea with more than 5 episodes per hour.

I have had an arterial bypass or angioplasty.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants in the waitlist control group will not receive immediate treatment and will be monitored for 3 months

3 months

Treatment

Participants receive cognitive-behavioral therapy for insomnia to assess changes in brain responses and connectivity

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months and 1 year

1 year

Treatment Details

Interventions

• Cognitive-Behavioural therapy for insomnia (CBT-I) (Behavioral Intervention)

Trial Overview The study tests if Cognitive-Behavioural therapy for insomnia (CBT-I) can normalize brain responses during cognitive tasks and rest in people with chronic insomnia. It aims to improve attentional processing by altering activation in specific brain regions related to memory and emotions.

Participant Groups

Group I: Immediate intervention Experimental Treatment 1 Intervention

Group II: Waitlist Active Control 1 Intervention

Cognitive-Behavioural therapy for insomnia (CBT-I) is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Cognitive-Behavioral Therapy for Insomnia for:

• Chronic insomnia

🇪🇺 Approved in European Union as CBT-I for:

• Insomnia
• Sleep disorders

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Perform Center, Concordia University Montréal, Canada

Who Is Running the Clinical Trial?

Concordia University, Montreal

Lead Sponsor

Trials

30

Patients Recruited

5,200+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1417

Patients Recruited

26,550,000+

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019] Cognitive-behavioral therapy for insomnia (CBT-I) is the treatment of choice for chronic insomnia. Together with advantages it has such limitations like shortage of trained staff and low response rate. That is why the alternative methods of CBT-I induce high interest: bibliotherapy, phone psychotherapy, brief behavioral therapy and online-CBT-I. Hypnotics administration is recommended as adjuvant to extent the CBT-I effect. It may also be used as monotherapy when CBT-I is unavailable.

2. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018] Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for persistent insomnia. The purpose of this study was to examine the effectiveness of and response patterns to CBT-I among daytime and shift workers with insomnia over a 24-month follow-up in occupational health services (OHS).

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018] The effectiveness of cognitive behavioural therapy for insomnia (cbt-i) has been demonstrated in randomised controlled trials (rct's) with primary insomnia patients and, more recently, with comorbid insomnia patients. The clinical impact of the treatment is mainly on sleep quality and the use of medication and to a lesser extent on daytime functioning. So far there have been very few studies of the effectiveness of cbt-i in clinical settings.

4. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022] Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be efficacious and now is considered the first-line treatment for insomnia for both uncomplicated insomnia and insomnia that occurs comorbidly with other chronic disorders (comorbid insomnia). The purposes of this review are to provide a comprehensive summary of the efficacy data (for example, efficacy overall and by clinical and demographic considerations and by CBT-I formulation) and to discuss the future of CBT-I (for example, what next steps should be taken in terms of research, dissemination, implementation, and practice).

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022] To test the efficacy of cogntive-behavioral therapy for insomnia (CBT-I) as a supplement treatment for psychiatric outpatients. Comorbid insomnia is prevalent among individuals with varied psychiatric disorders and evidence indicates that CBT-I may be effective for reducing insomnia and other psychiatric symptoms.

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022] Because psychological approaches are likely to produce sustained benefits without the risk for tolerance or adverse effects associated with pharmacologic approaches, cognitive behavioral therapy for insomnia (CBT-i) is now commonly recommended as first-line treatment for chronic insomnia.

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022] Cognitive behavioral therapy for insomnia (CBT-I) is the most prominent nonpharmacologic treatment for insomnia disorders. Although meta-analyses have examined primary insomnia, less is known about the comparative efficacy of CBT-I on comorbid insomnia.

8. England pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023] : Cognitive behavioral treatment for insomnia (CBT-I) is the first line of treatment for insomnia. However, the expanded use of CBT-I is limited by the number of specialty-trained clinicians in addition to the duration and cost of individual treatment sessions. One viable option is a single-session educational group format delivered by a trained health educator.