Cognitive Behavioral Therapy for Insomnia in Cancer Survivors

Overseen By Daniel Hall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Sleep apnea, Epilepsy, Serious mental illness, 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: 7

Duration: 4 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Survivorship Sleep Program, Cognitive Behavioral Therapy for Insomnia, CBT-I, Survivorship Sleep Program for cancer survivors?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for cancer survivors, with studies indicating significant improvements in sleep quality. For example, a study on the Sleep Treatment Education Program (STEP-1) found that participants had significantly lower insomnia symptoms after one month, suggesting that similar CBT-I programs can help cancer survivors manage insomnia. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia safe for cancer survivors?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe for cancer survivors, as it is a non-drug treatment that focuses on changing sleep-related thoughts and behaviors. Studies have shown it to be acceptable and feasible, with high satisfaction and retention rates among participants. ^{3 4 5 6 7}

How is the Survivorship Sleep Program treatment different from other treatments for insomnia in cancer survivors?

The Survivorship Sleep Program is unique because it offers a virtual, synchronous version of cognitive behavioral therapy for insomnia (CBT-I) specifically adapted for cancer survivors, making it more accessible and tailored to their unique needs compared to traditional in-person CBT-I. ^{3 4 5 8 9}

What is the purpose of this trial?

The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.

Research Team

Daniel Hall, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adult cancer survivors who've finished their primary treatment and are struggling with chronic insomnia. Participants must have had nonmetastatic, localized, or regional solid or blood cancers and meet specific criteria for insomnia severity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Survivorship Sleep Program (SSP) with 4 weekly sessions, delivered either individually or in groups, followed by optional booster sessions.

4 weeks

4 virtual sessions

Booster Sessions

Participants receive 3 monthly booster sessions to reinforce the treatment effects.

12 weeks

3 virtual sessions

Follow-up

Participants are monitored for changes in insomnia severity, emotional distress, work-related functioning, and other sleep metrics.

4 weeks

Treatment Details

Interventions

• Survivorship Sleep Program

Trial Overview The study tests different ways to deliver a Survivorship Sleep Program using Cognitive Behavioral Therapy for Insomnia (CBT-I). It compares individual vs. group sessions, with some getting additional 'booster' sessions to see which method helps most with sleep issues.

Participant Groups

Group I: Group 4: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions Experimental Treatment 1 Intervention

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session), followed by 3 monthly booster sessions.

Group II: Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions Experimental Treatment 1 Intervention

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session), followed by 3 monthly booster sessions.

Group III: Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions Experimental Treatment 1 Intervention

4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.

Group IV: Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions Experimental Treatment 1 Intervention

4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.

Survivorship Sleep Program 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 in cancer survivors

Approved in European Union as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia in cancer patients and survivors

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

The Sleep Treatment Education Program-1 (STEP-1) significantly reduced insomnia symptoms in cancer survivors, with mean Insomnia Severity Index scores dropping from 15.73 at baseline to 9.73 at one-month follow-up, indicating its potential efficacy as a treatment.

STEP-1 can be effectively delivered via videoconference, making it a more accessible option for cancer survivors who may face barriers to traditional therapy, thus improving their chances of receiving necessary insomnia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Sleep Treatment Education Program (STEP-1): A single-session educational workshop addressing insomnia in cancer survivors. Chevalier, LL., Fine, E., Sharma, A., et al.[2023]

This study aims to evaluate the effectiveness of Brief Behavioral Therapy for Insomnia (BBTI) in reducing insomnia among 158 cancer survivors, marking the first time this approach is tested in such a diverse group.

The primary outcome will be assessed using the Insomnia Severity Index (ISI), with follow-up assessments planned at 1, 3, and 12 months to determine the durability of the intervention's effects on sleep quality and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Kwon, M., Dickerson, SS., Wilding, GE., et al.[2023]

Internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) significantly improved sleep outcomes in 255 breast cancer survivors with clinically significant sleep disturbances, showing a strong effect on insomnia severity (Cohen's d = 1.17).

The benefits of iCBT-I were not only immediate but also sustained at follow-up, indicating its potential as a low-cost and effective treatment option that could be integrated into cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. Zachariae, R., Amidi, A., Damholdt, MF., et al.[2023]

The Survivorship Sleep Program (SSP), a synchronous virtual cognitive behavioral therapy for insomnia (CBT-I) tailored for cancer survivors, demonstrated high feasibility and acceptability, with 90% retention and 100% attendance among participants.

The SSP led to significant reductions in insomnia severity compared to enhanced usual care, with a large effect size (Cohen d = 1.19) that was maintained at a 1-month follow-up, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Hall, DL., Arditte Hall, KA., Gorman, MJ., et al.[2023]

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to significantly improve sleep quality and psychological outcomes in cancer patients and survivors, based on a review of 12 studies.

CBT-I not only enhances sleep but may also positively affect mood, fatigue, and overall quality of life, and it can be delivered through various methods to reach more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. Garland, SN., Johnson, JA., Savard, J., et al.[2022]

A pilot study involving 30 Spanish-speaking breast cancer survivors showed that a 6-week eHealth Cognitive-Behavioral Therapy for Insomnia (CBT-I) intervention was highly acceptable and feasible, with excellent recruitment (95%) and retention (97%).

Post-treatment results indicated that CBT-I significantly improved insomnia symptoms, sleep disturbance, and sleep efficiency, with medium to large effect sizes, demonstrating its preliminary efficacy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. Oswald, LB., Morales-Cruz, J., Eisel, SL., et al.[2023]

In a study involving 96 cancer survivors, higher levels of social support were linked to better adherence to cognitive-behavioral therapy for insomnia (CBT-I) and improved sleep outcomes, indicating that social support plays a crucial role in treatment success.

Both social support and CBT-I treatment independently contributed to reduced insomnia severity, suggesting that enhancing social support could be a valuable strategy to improve adherence and effectiveness of insomnia interventions in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment. Kamen, C., Garland, SN., Heckler, CE., et al.[2020]

Breast cancer survivors experience higher rates of insomnia, and a study involving 25 participants showed that a virtual assistant delivering cognitive behavioral therapy for insomnia (CBT-I) was perceived as feasible and acceptable for managing their sleep issues.

After testing the prototype, 79% of participants expressed interest in using the virtual assistant to track sleep patterns, and features like lifestyle modification and relaxation exercises were also well-received, indicating potential for broader application in similar high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Breast Cancer Survivors' Perceptions of Using Voice-Activated Technology to Address Insomnia: Feasibility Study Featuring Focus Groups and In-Depth Interviews. Arem, H., Scott, R., Greenberg, D., et al.[2020]

References

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

Evaluating the Sleep Treatment Education Program (STEP-1): A single-session educational workshop addressing insomnia in cancer survivors. [2023]

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

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. [2023]

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

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. [2023]

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

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. [2022]

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

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment. [2020]

9. Canada pubmed.ncbi.nlm.nih.gov

Assessing Breast Cancer Survivors' Perceptions of Using Voice-Activated Technology to Address Insomnia: Feasibility Study Featuring Focus Groups and In-Depth Interviews. [2020]