Optimizing virtual cognitive behavioral therapy for insomnia in cancer survivors
Innovating CBT-I for Cancer Survivors: An Optimization Trial
This study is testing different ways of providing online therapy for insomnia to see which method works best for cancer survivors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06181643 on ClinicalTrials.gov |
What this trial studies
This project aims to optimize the delivery of cognitive behavioral therapy for insomnia (CBT-I) specifically for cancer survivors through a factorial, randomized controlled trial. The trial will evaluate different combinations of individual versus group therapy formats and the inclusion of booster sessions to determine the most effective approach for reducing insomnia severity. Participants will be monitored for changes in insomnia and related outcomes over an 8 to 16-week period using various metrics, including sleep diaries and wearable devices. The findings are expected to enhance cancer survivorship care by providing a scalable, virtually delivered intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a history of nonmetastatic cancer and are experiencing chronic insomnia.
Not a fit: Patients with untreated sleep disorders other than insomnia, serious mental health issues, or those unable to communicate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall well-being for cancer survivors suffering from chronic insomnia.
How similar studies have performed: Previous studies have shown promise in using cognitive behavioral therapy for insomnia in various populations, suggesting potential success for this novel application in cancer survivors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of nonmetastatic, localized, or regional solid or blood malignancy(ies) * Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted. * Chronic insomnia (DSM-5 criteria) * 18 years of age or older Exclusion Criteria: * Self-reported inability to speak and write in English * Undertreated noninsomnia sleep disorder (e.g., sleep apnea) * Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and/or psychiatric hospitalization in the past year * Unwilling or unable to discontinue night shift work
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Hall, PhD — Massachusetts General Hospital
- Study coordinator: Daniel Hall, PhD
- Email: hall@mgh.harvard.edu
- Phone: 617-724-6300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.