Cognitive Behavioral Therapy for Chronic Insomnia

Overseen By Caleb Bolden, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Non-insomnia sleep disorder, Epilepsy, Serious mental illness, Suicidality, others

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

Compensation: Varies

Number of Visits: 14

Duration: 6 weeks

198 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new virtual sleep program for cancer survivors with long-term insomnia. It compares Cognitive Behavioral Therapy for Insomnia, a specialized sleep program, with standard sleep care to determine which better reduces insomnia symptoms. The study invites cancer survivors with chronic insomnia to participate. Participants will receive either a virtual sleep program or enhanced usual care, which includes sleep tips and a therapy referral. The goal is to improve sleep and overall well-being for those affected by cancer-related insomnia.

As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research aimed at enhancing sleep quality and overall well-being for cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does allow the use of hormonal, maintenance, oral, and immunotherapies.

What prior data suggests that Cognitive Behavioral Therapy for Insomnia is safe for cancer survivors?

Previous studies have shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is a safe treatment option. Research supports its use as a first-choice treatment for long-term insomnia due to its safety and effectiveness. This therapy does not involve medication, reducing the risk of drug-related side effects. However, some evidence suggests that CBT-I might cause temporary issues like fatigue or reduced motivation. Despite these potential problems, the overall findings are positive, with many individuals experiencing long-lasting improvements in their sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic insomnia because they offer innovative approaches beyond traditional methods like medication or standard cognitive behavioral therapy. The Survivorship Sleep Program is unique because it involves four weekly virtual sessions plus a booster, making it accessible and convenient for participants who might struggle with in-person attendance. Meanwhile, the Enhanced Usual Care provides a comprehensive approach by combining sleep hygiene education with referrals for specialized therapy, bridging the gap between standard care and more intensive interventions. These methods aim to address insomnia more effectively by integrating flexible, personalized care into patients' lives.

What evidence suggests that this trial's treatments could be effective for chronic insomnia in cancer survivors?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive as part of the Survivorship Sleep Program, effectively reduces insomnia symptoms. Studies report significant improvement, with one study noting a strong effect. CBT-I also helps individuals sleep better and fall asleep faster. The benefits can last up to ten years, with many individuals no longer experiencing insomnia. This suggests that CBT-I can be a powerful way to manage long-term insomnia, especially for cancer survivors. Meanwhile, participants in the Enhanced Usual Care arm will receive a sleep hygiene handout and a referral for CBT-I offered through MGH or community partners. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for cancer survivors suffering from chronic insomnia, regardless of their phase in survivorship. It includes those who've completed primary treatment and those with metastatic cancer. Participants must be willing to engage in virtual therapy sessions.

Inclusion Criteria

I have been diagnosed with chronic insomnia.

Cancer survivor with specific criteria as defined

Exclusion Criteria

I cannot speak or write in English.

I have a sleep disorder other than insomnia that's not fully treated.

Unwilling or unable to discontinue night shift work

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Survivorship Sleep Program (SSP) or Enhanced Usual Care (EUC) over 6 weeks, including 4 weekly virtual sessions and 1 booster session

6 weeks

4 virtual sessions, 1 booster session

Follow-up

Participants are monitored for changes in insomnia severity and secondary outcomes such as sleep efficiency, emotional distress, and fatigue

12 weeks

Assessments at week 10 and week 18

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy - Insomnia
• Enhanced Usual Care

Trial Overview

The study compares the Survivorship Sleep Program, which involves Cognitive Behavioral Therapy for Insomnia (CBT-I), to Enhanced Usual Care. The goal is to see if CBT-I can reduce insomnia severity among participants more effectively than usual care practices.

How Is the Trial Designed?

Group I: Survivorship Sleep Program Experimental Treatment 1 Intervention

4, weekly virtual sessions of the Survivorship Sleep Program plus 1 booster session

Group II: Enhance Usual Care Active Control 1 Intervention

A sleep hygiene handout and a referral for CBT-I offered through MGH or community partners.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Group-based cognitive behavioral therapy for insomnia (CBT-I) is a feasible and acceptable treatment for veterans with insomnia, showing medium to large effect sizes in improving various sleep measures.

The treatment demonstrated initial effectiveness in reducing insomnia symptoms, with improvements maintained for at least one month after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. Koffel, E., Farrell-Carnahan, L.[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]

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) has been proven effective in improving both short- and long-term outcomes for patients with uncomplicated and comorbid insomnia, indicating its strong efficacy as a treatment.

Future research on CBT-I should focus on enhancing treatment efficacy for clinically relevant outcomes, improving its effectiveness in community settings, and expanding training for practitioners to better disseminate the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of cognitive behavioral therapy for insomnia: what important research remains to be done? Vitiello, MV., McCurry, SM., Rybarczyk, BD.[2018]

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 (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 behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

This clinical trial involves 625 adults with hypertension and insomnia, comparing the efficacy of two cognitive behavioral treatments for insomnia (BBTI and SHUTi) against enhanced usual care over a period of 12 months.

The study aims to assess not only sleep disturbances but also the impact of these treatments on comorbid conditions like blood pressure and quality of life, potentially influencing real-world treatment delivery for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. Levenson, JC., Rollman, BL., Ritterband, LM., et al.[2019]

Cognitive behavior therapy (CBT) for insomnia is an effective nonpharmacologic intervention that can lead to reliable and sustained improvements in sleep patterns for patients suffering from chronic insomnia, which affects 10 to 30 percent of the population.

CBT includes various components such as cognitive psychotherapy, sleep hygiene, and relaxation techniques, typically delivered over four to eight weekly sessions, making it a recommended first-line treatment for chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic management of chronic insomnia. Harsora, P., Kessmann, J.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) is recognized as the best treatment for chronic insomnia, yet it is significantly underutilized despite the high number of people affected by insomnia disorder.

The article highlights the need for further research on how to effectively deliver CBT-I, identify suitable candidates for the therapy, and measure the quality of care provided, which are essential for improving its real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. Buenaver, LF., Townsend, D., Ong, JC.[2019]

Cognitive Behavioral Therapy for insomnia (CBTi) is an effective alternative to medication for treating insomnia, which affects up to 30% of adults, and has been shown to improve various sleep-related outcomes such as sleep onset latency and sleep quality.

CBTi includes techniques like sleep hygiene and cognitive therapy, making it a safe and beneficial option for both adults and adolescents, although access to this therapy can be limited by certain barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. Haynes, J., Talbert, M., Fox, S., et al.[2018]

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