What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacologic treatment that generally has minimal side effects, primarily involving the potential for initial discomfort as patients adjust to new sleep patterns and behaviors. Pharmacotherapy, often used when behavioral interventions are insufficient, can have more significant side effects. Common medications like nonbenzodiazepine benzodiazepine receptor agonists (e.g., zolpidem) and antipsychotics (e.g., risperidone) can cause drowsiness, confusion, gait instability, nocturnal falls, and increased motor restlessness. These side effects are particularly concerning in populations with cognitive impairments or other comorbidities.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of insomnia, including nonbenzodiazepine hypnotics like zolpidem and eszopiclone, which are commonly used to manage sleep disturbances. However, cognitive-behavioral therapy for insomnia (CBT-I) is a non-pharmacologic approach that has shown significant efficacy in improving sleep patterns and reducing insomnia symptoms. While CBT-I itself is not a medication and thus not subject to FDA approval, it is a well-established, evidence-based treatment that is often recommended as a first-line therapy for chronic insomnia. Studies have demonstrated that CBT-I can be effectively delivered through various formats, including face-to-face sessions and digital platforms, making it accessible to a broader range of patients.

What other types of research exist?

Promising novel alternatives to Stepped Care CBT-I for insomnia patients include: 1) Telephone-based CBT-I, which has shown efficacy in reducing insomnia severity and improving sleep quality. 2) Web-based CBT-I programs, such as Insomnet, which offer accessibility and cost-effectiveness while maintaining treatment efficacy. 3) Timed melatonin administration, which has demonstrated improvements in sleep onset and quality in patients with delayed sleep-wake phase disorder. 4) Hypnosis, which has shown potential benefits for reducing insomnia symptoms, though further standardization and research are needed.

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CBT-I for Insomnia in Cancer Patients

N/A

Recruiting

Led By Josée Savard, Ph.D.

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

To be aged 18 years and older

Have received a diagnosis of non-metastatic cancer (any type)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to help cancer patients with insomnia using a step-by-step treatment plan. It starts with an online self-help program and adds therapy sessions if needed. The goal is to see if this method works well in real-world cancer clinics.

Who is the study for?

This trial is for adults over 18 with non-metastatic cancer who can read and understand French or English, have basic cognitive abilities, and internet access. It's not suitable for those with severe psychological issues like major depression, significant cognitive impairments such as dementia, or insomnia caused by temporary conditions.

What is being tested?

The study tests a stepped care approach to treating insomnia in cancer patients using web-based CBT-I (Insomnet) followed by up to three professional therapy sessions if needed. The effectiveness of this method will be compared against usual care in a real-world setting across four hospitals.

What are the potential side effects?

As the intervention involves non-pharmacological treatment (CBT-I), typical medication side effects are not expected. However, participants may experience discomfort discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with cancer that has not spread.

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I have been diagnosed with cancer that has not spread.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1) Change in Insomnia Severity Index Scores

1) Psychologists' adherence to the protocol

10) Satisfaction with Life Scale (SWLS)

+10 more

Secondary study objectives

1) Demographic characteristics

2) Evidence-Based Practice Attitudes Scale (EBPAS)

3) Workplace Stress Scale (WSS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stepped care CBT-IExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Web-based cognitive-behavioral therapy for insomnia (CBT-I)

2013

N/A

~180

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy for Insomnia (CBT-I) works by addressing the thoughts and behaviors that contribute to insomnia, using techniques such as sleep restriction, stimulus control, cognitive restructuring, and relaxation training to promote healthier sleep patterns. Pharmacological treatments, including benzodiazepines, non-benzodiazepine sleep aids, and melatonin receptor agonists, enhance sleep by affecting neurotransmitters or mimicking melatonin. Understanding these mechanisms helps patients and healthcare providers select the most suitable treatment, improving sleep quality and overall health.