Recruiting

Cognitive Behavioral Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT06807086

Conditions

Insomnia Chronic

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy - Insomnia

Enhanced Usual Care

Study Details

Brief summary:

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.

Conditions

Insomnia Chronic

Study ID

NCT06807086

Start date

Jan 1, 2025

Status verified date

Mar, 2026

Completion date

Dec 28, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Cancer survivor, defined as:

1. (A) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and completion of primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted; or
2. (B) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and current primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy); Use of hormonal, maintenance, oral, and immunotherapies is permitted; or
3. (C) history of metastatic sold or blood malignancy (ies) taking hormonal, maintenance, oral, or immunotherapies to prevent further disease progression.
2. Chronic insomnia (DSM-5 criteria)
3. Age 18 years or older

Exclusion Criteria:

1. Self-reported inability to speak and write in English
2. Undertreated non-insomnia sleep disorder (e.g., sleep apnea)
3. Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and/or psychiatric hospitalization in the past year
4. Unwilling or unable to discontinue night shift work

Study Design

Enrollment

198 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Enhance Usual Care

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

experimental: Survivorship Sleep Program

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

Interventions

Cognitive Behavioral Therapy - Insomnia

The Survivorship Sleep Program is a virtual program based on cognitive behavioral therapy for insomnia (CBT-I), which teaches evidence based skills to improve sleep-related behaviors, expectations, and environment, to promote relaxation, and to reduce worry. It also involves reducing the time spent in bed in order to improve the quantity and quality of sleep over time. The Survivorship Sleep Program is delivered in 4 weekly sessions by a trained facilitator and includes considerations specific to managing insomnia after cancer diagnosis and treatment. Additionally, 1 booster session is offered at week 6.

Enhanced Usual Care

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

Primary outcome measure

  • Insomnia Severity Index [ Time Frame: Screening, baseline, week 6, week 10, and week 18 ]

Central Contacts and Locations

Central contacts

Daniel L Hall, PhD

617-724-6300hall@mgh.harvard.edu

Caleb Bolden, BA

6039697927cbolden2@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Daniel Hall, PhD

617-724-6300hall@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.