Cognitive Behavioural Therapy vs Sleep Hygiene for Sleep Disorders

Overseen By Sheryl Green, C.Psych

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Must not be taking: Sleep aids

Disqualifiers: Severe depression, Psychotic, Unstable condition, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two non-medical treatments for sleep issues in pregnant and postpartum individuals: Cognitive Behavioural Therapy for Insomnia (CBT-I) and Sleep Hygiene education. The researchers aim to determine which method better improves sleep for those experiencing sleep difficulties during pregnancy. Participants will attend group workshops designed to address the sleep changes and challenges faced during pregnancy. This trial suits pregnant individuals in their first to third trimester who are experiencing sleep difficulties and are fluent in English. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance sleep health for pregnant individuals.

Will I have to stop taking my current medications?

The trial requires that if you are taking prescription medications, the dose and type must remain stable throughout the study. If you are currently using sleep aids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cognitive behavioral therapy for insomnia (CBT-I) safely and effectively treats insomnia. Experts often recommend it as the first choice for managing sleep problems, even during pregnancy and after childbirth. Studies indicate that CBT-I usually has few side effects. Some people might initially feel more tired or less motivated, but these feelings are typically temporary.

Sleep hygiene education is another common method for addressing sleep issues. It involves learning good sleep habits, such as maintaining a regular sleep schedule and creating a comfortable sleep environment. Sleep hygiene is considered safe and typically doesn't cause negative effects.

In summary, both CBT-I and sleep hygiene are safe and well-tolerated methods to improve sleep, especially for those who prefer non-medical treatments during pregnancy and after childbirth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they target sleep disorders in perinatal individuals with tailored approaches. Cognitive Behavioural Therapy (CBT) for Insomnia is unique because it provides empirically supported strategies specifically modified for pregnancy and postpartum transitions, potentially offering a more personalized and effective solution compared to standard CBT. Meanwhile, the Sleep Hygiene Workshop adapts typical sleep hygiene education to better address the unique challenges faced during the perinatal period, providing a practical approach that aligns with standard care but with targeted enhancements. These adaptations could lead to more effective management of insomnia in this specific population, offering hope for improved sleep outcomes.

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

This trial will compare Cognitive Behavioral Therapy for Insomnia (CBT-I) with Sleep Hygiene Education for treating sleep disorders. Research has shown that CBT-I effectively treats long-term sleep problems. Studies have found that CBT-I helps individuals sleep better and fall asleep faster. It works as well as sleep medications but without side effects and with a lower risk of insomnia returning. Group sessions of CBT-I have also improved sleep. In contrast, sleep hygiene education, which teaches healthy sleep habits, can help with sleep issues but may not be as effective as CBT-I. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking pregnant individuals in their first or second trimester who are experiencing sleep difficulties, as indicated by a score of 8 or higher on the Insomnia Severity Index. It aims to provide early and proactive non-medication-based treatment for insomnia.

Inclusion Criteria

Fluent in English

First, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early/proactive benefit of sleep intervention

I have trouble sleeping, scoring 8 or higher on a sleep difficulty scale.

Exclusion Criteria

I have a sleep disorder that is not insomnia.

My health condition is currently unstable.

I am currently using sleep aids or my prescription medications will remain the same during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Behavioural Therapy for Insomnia or Sleep Hygiene education in group workshops

8 weeks

Weekly group workshops

Follow-up

Participants are monitored for changes in sleep quality and psychological measures post-treatment

12 weeks postpartum

3 assessment points (pre-treatment, post-treatment, 12 weeks postpartum)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioural Therapy for Insomnia Workshop
• Sleep Hygiene Workshop

Trial Overview The study compares two non-medical treatments: a group workshop on Cognitive Behavioural Therapy (CBT) for insomnia, which has been successful in treating pregnancy-related sleep issues, versus a Sleep Hygiene education workshop that's commonly offered to improve sleep problems.

How Is the Trial Designed?

Group I: Cognitive Behavioural Therapy for Insomnia Workshop Experimental Treatment 1 Intervention

The Cognitive Behavioural Therapy (CBT) for Insomnia workshop contains empirically supported strategies for insomnia that have been modified to target the transitions and concerns faced by perinatal individuals. CBT is the first-line treatment for insomnia and promising research on CBT for insomnia specifically during pregnancy and postpartum is emerging.

Group II: Sleep Hygiene Workshop Active Control 1 Intervention

The Sleep Hygiene workshop contains psychoeducation on sleep hygiene and has been modified to target the transitions and concerns faced by perinatal individuals. Sleep hygiene is commonly utilized as a treatment for insomnia in general practice, with the information provided through verbal advice and a sleep hygiene info sheet. As such, the sleep hygiene protocol used in this study reflects standard care commonly offered to perinatal individuals outside of our specialized clinic.

Cognitive Behavioural Therapy for Insomnia Workshop is already approved in United States, European Union for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Sleep disturbances during pregnancy

Approved in European Union as CBT-I for:

• Insomnia
• Sleep disturbances during pregnancy

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Published Research Related to This Trial

A study involving 210 adults with insomnia compared three interventions: a cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI, and sleep hygiene education (SHE). All interventions significantly improved insomnia severity, anxiety, depressive symptoms, and quality of life, but there were no significant differences in effectiveness between the groups.

Self-help CBTI emerged as a preferred option in the stepped-care model for insomnia due to its comparable efficacy and adherence rates to workshop-based interventions, while being more accessible and requiring fewer resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial. Wong, KY., Chung, KF., Au, CH.[2021]

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]

Both internet-based cognitive behavioral treatments for insomnia (MCT and SRT) were significantly more effective than care as usual, with MCT showing a large effect size for insomnia severity (Cohen's d = -1.15) after eight weeks.

Participants in the multi-component treatment (MCT) reported higher satisfaction compared to those in the sleep restriction treatment (SRT), although both treatments had similar efficacy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia. Krieger, T., Urech, A., Duss, SB., et al.[2020]

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) 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) is an effective multi-component treatment for chronic insomnia, which affects 6-10% of the population and can lead to various health issues; it is recommended as the first-line intervention for insomnia.

Despite its proven efficacy and comprehensive evidence base, CBT-I is not widely disseminated, highlighting the need for increased awareness and training among clinicians and researchers to improve treatment access for those suffering from insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer. Walker, J., Muench, A., Perlis, ML., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as the first-line treatment for insomnia, yet many patients in Europe still primarily receive hypnotic medications instead of CBT-I.

A Task Force proposed the creation of a European CBT-I Academy to standardize training and accreditation for health professionals, aiming to improve the delivery of CBT-I across Europe and align treatment practices with current guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Academy for Cognitive Behavioural Therapy for Insomnia: An initiative of the European Insomnia Network to promote implementation and dissemination of treatment. Baglioni, C., Altena, E., Bjorvatn, B., et al.[2020]

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]

A psycho-educational CBT-I workshop designed for men was effective in reducing insomnia and depression symptoms, with high satisfaction ratings from participants, indicating its acceptability and potential impact.

Out of 74 men who attended the workshops, many had never sought help for their insomnia before, highlighting the need for accessible treatment options and the effectiveness of this self-referral model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and evaluation of a large-scale self-referral CBT-I intervention for men who have insomnia: an exploratory study. Archer, M., Brown, JS., Idusohan, H., et al.[2019]

Cognitive-Behavioral Therapy (CBT) for insomnia is a structured approach that effectively changes poor sleep habits and beliefs, making it the first-line treatment for chronic insomnia in adults according to clinical guidelines.

CBT leads to more significant and lasting improvements in sleep quality and insomnia symptoms compared to medication alone, despite requiring more time from both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approach to treating insomnia M Morin, C., Beaulieu-Bonneau, S.[2019]

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]

Citations

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Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer There is an overwhelming preponderance of evidence that CBT-I is an efficacious treatment for chronic insomnia [15; 38]. Specifically, the literature supports ...

2. 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 ...

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Effectiveness of group-delivered cognitive behavioural ... Results from a meta-analysis showed that group-delivered CBT-I led to improved sleep quality and better sleep, especially regarding sleep onset latency, sleep ...

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Effectiveness of Cognitive Behavioural Therapy for ... 2020, 2021). Hiscock et al. (2019) reported that their CBT-I intervention was more effective in reducing sleep problems than treatment as usual.

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Digital Cognitive Behavioral Therapy vs Medication ... In this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits ...

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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 ...

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Negative effects of cognitive behavioral therapy for insomnia Evidence exists that cognitive behavioral therapy for insomnia (CBT-I) can lead to negative effects (e.g., exhaustion, reduced motivation). Psychometrically ...

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a focus on components of cognitive behavioral therapy for ... CBT-I is typically conducted over 4–8 sessions by certified health professionals [9]. It is a safe therapy with lasting effects and only ...

9. academic.oup.com academic.oup.com/sleep/article/44/12/zsab185/6325440

Mode of delivery of Cognitive Behavioral Therapy for Insomnia We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.