Cognitive Behavioural Therapy for Chronic Insomnia

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Cognitive-Behavioural Therapy for Insomnia (CBT-I) to determine its effectiveness in improving sleep and mental focus for individuals with chronic insomnia. The researchers aim to discover whether this therapy alters brain function during memory tasks and rest. Individuals who have experienced long-term sleep difficulties, struggle with daytime concentration, and have not previously tried CBT-I may be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding of how CBT-I can benefit those with insomnia.

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 prior data suggests that Cognitive-Behavioural Therapy for insomnia is safe?

Research shows that Cognitive-Behavioral Therapy for Insomnia (CBT-I) safely and effectively improves sleep. Studies have found it works as well as sleep medication but without side effects. People who try CBT-I often experience fewer insomnia relapses, and their sleep continues to improve over time. Additionally, reviews of multiple studies confirm that both individual and group CBT-I sessions help people fall asleep faster and enjoy better sleep quality. CBT-I is widely recommended as the first choice for treating insomnia, underscoring its reputation as a safe and well-tolerated option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive-Behavioural Therapy for Insomnia (CBT-I) because it offers a natural, drug-free approach to treating chronic insomnia. Unlike standard treatments like prescription sleep medications, which can have side effects and risk of dependence, CBT-I focuses on changing the behaviors and thoughts that contribute to insomnia. It empowers individuals to develop healthier sleep patterns and improve sleep quality through techniques like sleep restriction and cognitive restructuring. This makes CBT-I a sustainable and effective long-term solution for those struggling with chronic insomnia.

What evidence suggests that Cognitive-Behavioural Therapy for insomnia (CBT-I) might be an effective treatment for chronic insomnia?

Research has shown that Cognitive-Behavioural Therapy for Insomnia (CBT-I) effectively treats long-term sleep problems. In this trial, participants in the immediate intervention arm will receive CBT-I, which studies have found to be as effective as sleep medications, but without the side effects. For example, one study found that people in a group CBT-I program experienced less severe insomnia than those on a waiting list. Strong evidence supports CBT-I as a proven method to improve sleep, making it a reliable choice for those struggling with insomnia. ^{1 2 5 6 7}

Who Is on the Research Team?

Thanh Dang-Vu, MD PhD

Principal Investigator

Concordia University, Montreal

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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 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) 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]

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]

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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796223/

Cognitive-Behavioral Therapy for Insomnia: An Effective ... CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S138994572500156X

Effectiveness of group-delivered cognitive behavioural ... Group-delivered CBT-I reduced insomnia severity compared with a waiting list. Group-delivered CBT-I is a suitable low-threshold insomnia treatment in primary ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70058

Effectiveness of Cognitive Behavioural Therapy for ... Overall, based on the outcomes from studies included in this review, CBT-I did not improve mental health or quality of life in people with NDC.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10002474/

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer Conclusion and Further Training. There is an overwhelming preponderance of evidence that CBT-I is an efficacious treatment for chronic insomnia [15; 38].

5. nature.com nature.com/articles/s41746-025-01514-4

Systematic review and meta-analysis on fully automated ... This systematic review and meta-analysis evaluated the effectiveness of FA dCBT-I across 29 randomized controlled trials (RCTs) involving 9475 participants.

6. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2814164

Components and Delivery Formats of Cognitive Behavioral ... The findings suggest that beneficial cognitive behavioral therapy for insomnia may include cognitive restructuring, third-wave components, sleep restriction, ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09013-3

Digitally delivered cognitive behavioral therapy for insomnia ... Cognitive behavioral therapy for insomnia (CBT-I) is an effective and safe treatment for insomnia [8, 9] and is recommended as first-line ...