Cognitive Behavioural Therapy for Chronic Insomnia

Overseen By Thanh Dang-Vu, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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 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: Unknown

Duration: 3 months

120 Participants Needed

Trial Summary

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. ^{1 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}

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.

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.

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)

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

Who Is Running the Clinical Trial?

Concordia University, Montreal

Lead Sponsor

Trials

30

Recruited

5,200+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Cognitive behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms over a 24-month follow-up among 59 media workers, with 62% of participants showing moderate improvement.

The study found that working hour arrangements did not impact the effectiveness of CBT-I, indicating that this treatment can benefit both daytime and shift workers with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. Järnefelt, H., Sallinen, M., Luukkonen, R., et al.[2018]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep quality, sleep onset, and sleep efficiency in 76 patients with primary insomnia over a 6-week group course in a clinical setting.

CBT-I also led to reductions in medication use and improvements in patients' overall health and cognitive functioning, highlighting its effectiveness beyond just sleep improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. Van Houdenhove, L., Buyse, B., Gabriels, L., et al.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.

While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

Cognitive Behavioral Therapy for insomnia (CBT-i) is an effective first-line treatment for chronic insomnia, showing significant improvements in sleep onset latency (SOL) by about 19 minutes and wake after sleep onset (WASO) by about 26 minutes based on a review of 20 studies involving 1162 participants.

The benefits of CBT-i, which includes techniques like cognitive therapy and sleep hygiene, appear to be sustained over time, and importantly, no adverse effects were reported, making it a safe alternative to pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Trauer, JM., Qian, MY., Doyle, JS., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

A single 4-hour group workshop on cognitive behavioral treatment for insomnia (CBT-I) significantly improved insomnia symptoms in 45 participants, with Insomnia Severity Index scores dropping from an average of 20.09 to 11.89 after one month.

Participants also reported a reduction in sleep aid use, with 80% indicating better sleep quality and 20% achieving remission of insomnia, highlighting the effectiveness of this accessible treatment format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. Okun, ML., Glidewell, RN.[2023]

References

1. 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]

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

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]

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

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018]

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

We know CBT-I works, now what? [2022]

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

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]

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

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]

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

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

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

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]