Cognitive Behavioural Therapy for Chronic Insomnia
Palo Alto (17 mi)Overseen byThanh Dang-Vu, MD PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Concordia University, Montreal
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.
Is Cognitive-Behavioural therapy for insomnia (CBT-I) a promising treatment for chronic insomnia?Yes, Cognitive-Behavioural therapy for insomnia (CBT-I) is a promising treatment for chronic insomnia. It is considered the first choice for treating insomnia, even when it occurs alongside other health issues. CBT-I has been shown to be effective in improving sleep and is recommended as the main treatment option.35678
What data supports the idea that Cognitive Behavioural Therapy for Chronic Insomnia is an effective treatment?The available research shows that Cognitive Behavioural Therapy for Chronic Insomnia (CBT-I) is effective in improving sleep quality and reducing the need for medication. It is considered the first-line treatment for both uncomplicated insomnia and insomnia that occurs with other chronic disorders. Studies have shown that CBT-I is effective over long periods, such as 24 months, and can also help reduce symptoms of other psychiatric conditions when used as a supplementary treatment. While there are challenges like a shortage of trained staff, alternative methods like online therapy are being explored to make CBT-I more accessible.12367
What safety data exists for CBT-I treatment?CBT-I is considered a safe first-line treatment for chronic insomnia, with sustained benefits and no risk of tolerance or adverse effects associated with pharmacologic treatments. It is effective for both primary and comorbid insomnia, and its safety and efficacy have been demonstrated in various studies and meta-analyses.13457
Do I have to stop taking my current medications for this trial?Yes, you must stop taking hypnosedative medications at least 2 weeks before the first assessment. Also, you cannot participate if you are currently using medication for depression or anxiety.
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.Exclusion Criteria
I have sleep apnea with more than 5 episodes per hour.
I have had an arterial bypass or angioplasty.
I have a thyroid condition that hasn't been treated.
I have not had major surgery in the last 3 months.
I act out my dreams while sleeping.
My heart condition limits my daily activities.
I have had a stroke.
I experience insomnia symptoms more than three times a week.
My kidneys do not work well.
I am either over 65 or under 25 years old.
I have a current neurological disorder.
I have chronic pain that affects my sleep.
I have had a heart attack.
I have active cancer or was treated for cancer in the last 2 years.
I experience restless legs syndrome symptoms frequently each week.
I have had a brain lesion in the past.
I have been diagnosed with narcolepsy or another sleep disorder.
I am currently taking medication for depression or anxiety.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate interventionExperimental Treatment1 Intervention
Group II: WaitlistActive Control1 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 nearbySelect from list below to view details:
Perform Center, Concordia UniversityMontréal, Canada
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Who is running the clinical trial?
Concordia University, MontrealLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
[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.
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.
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).
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.
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.
[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.
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).
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.