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

Trial Summary

What is the purpose of this trial?

This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-related insomnia including subjective and objective sleep measures (i.e., sleep diaries, actigraphy), emotional distress, fatigue, and use of sleep medications. Notably, most CBT-I trials with cancer survivors who have completed primary treatment with curative intent (i.e., curvivors) but not those in treatment or living with metastatic cancer (i.e., metavivors). To enhance generalizability, this RCT will stratify enrollment by survivorship phase (1:1:1). This project in strengthened by partnerships with community organizations (SurvivorJourneys and Ellie Fund) and use of both quantitative (i.e., surveys, actigraphy) and qualitative methods (i.e., interviews) to inform considerations for future implementation. Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, namely an efficacious, virtually delivered intervention addressing chronic insomnia, one of the most deleterious concerns among the growing population of cancer survivors in the US. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in improving sleep for people with insomnia, including those with other health issues. Studies found that CBT-I helps reduce the time it takes to fall asleep, decreases night awakenings, and improves overall sleep quality, with benefits lasting at least a month. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe and does not have the risks associated with sleeping medications. It is a recommended treatment for insomnia and has been shown to be effective without causing harm. ^{6 7 8 9 10}

How is Cognitive Behavioral Therapy for Insomnia different from other treatments for chronic insomnia?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is unique because it focuses on changing unhelpful sleep habits and beliefs through structured sessions, rather than using medication. It includes techniques like sleep restriction, stimulus control, and cognitive restructuring, which help create lasting improvements in sleep patterns. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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) 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]

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 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]

References

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

The future of cognitive behavioral therapy for insomnia: what important research remains to be done? [2018]

2. England pubmed.ncbi.nlm.nih.gov

Are changes in worry associated with treatment response in cognitive behavioral therapy for insomnia? [2018]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. [2018]

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

Assessing the feasibility and acceptability of a cluster-randomized study of cognitive behavioral therapy for chronic insomnia in a primary care setting. [2021]

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

Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

An open trial of cognitive therapy for chronic insomnia. [2018]

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

Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]

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

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

10. England 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). [2021]

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

Nonpharmacologic management of chronic insomnia. [2022]

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

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

13. France pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral approach to treating insomnia [2019]

14. England pubmed.ncbi.nlm.nih.gov

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

15. England pubmed.ncbi.nlm.nih.gov

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