Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors

NCT05813392 | Recruiting

• 1 other identifier: 2022-376
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy of dCBT-I therapy for chronic insomnia among breast cancer survivors in China, we propose to conduct a randomized, parallel controlled clinical study in breast cancer survivors using a smartphone Chinese application (app) "resleep". Breast cancer survivors with chronic insomnia were recruited from our Breast Disease Center and externally, with the waiting group as a parallel control and the dCBT-I treatment group as an intervention group, in a 1:1 sample size. Intervention group (dCBT-I treatment group) will receive full self-help dCBT-I administered by smartphone APP for 6 weeks. The control group (waiting for treatment group) will not receive any additional interventions based on the original conventional treatment and will be followed up as planned, waiting for treatment.At the end of the 3-month follow-up, the decision to receive treatment was made according to the patient's wishes. The primary endpoint was the insomnia severity index (ISI) at the end of treatment and at 3 months of treatment.

Conditions

Chronic Insomnia

Keywords

Insomnia; Cognitive Behaviour Therapy for insomnia; breast cancer

Outcome Measures

Primary Outcomes (2)

• The insomnia severity index (ISI) scores

  immediately post-treatment

• The insomnia severity index (ISI) scores

  3-months follow-up

Secondary Outcomes (2)

• The insomnia severity index (ISI) scores

  6-months follow-up

• Online sleep diary measures

  up to 6-months follow-up

Other Outcomes (6)

• Generalized Anxiety Scale (GAD-7)

  up to 6-months follow-up

• Patient Health Questionnaire-9 (PHQ-9)

  up to 6-months follow-up

• the Short-Form 12 Health Survey (SF-12)

  up to 6-months follow-up

Study Arms (2)

dCBT-I group

EXPERIMENTAL

The dCBT-I group will receive full self-help dCBT-I through a smartphone APP for 6 weeks.

Behavioral: Digital Cognitive Behavioral Therapy for Insomnia

the wait-list group

NO INTERVENTION

The wait-list group will not receive dCBT-I, waiting for treatment.At the end of the 3-month follow-up, the decision whether to receive treatment will be made according to the participants' wishes.

Interventions

Digital Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP

dCBT-I group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Breast cancer diagnosed within 5 years
• Stable disease at the end of acute treatment (surgery, radiotherapy, chemotherapy) while meeting: ≥ 1 month after surgery, ≥ 3 months after the end of last chemotherapy, and ≥ 3 months after the end of last radiotherapy if radiotherapy is required.
• Satisfy the diagnostic criteria for chronic insomnia disorder according to the (International Classification of Sleep Disorders-the Third Edition, ICSD-3)\[ and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): problem with falling asleep or maintaining sleep for ≥3 months (≥3 times per week) with impaired daytime functioning, despite the availability of sleep opportunities.
• ISI score ≥12.
• Other sleep or psychiatric disorders, if present, must be stable and require no medication.
• Be proficient in the use of a cell phone application, and be comfortable reading, filling out the electronic questionnaire, communicating, and fully understanding the content.
• Sign the informed consent form. -

You may not qualify if:

• New breast cancer progression, recurrence, or metastasis within 3 months, requiring new radiotherapy or immunotherapy regimen
• Expected survival \<12 months due to all causes
• Presence of any of the following conditions: Concurrent active cancer or malignancy that is being treated other than breast cancer, shift work, alcohol abuse, substance abuse, significant suicidal ideation, bipolar disorder, aggressive behavior, mania, schizophrenia.
• Presence of a diagnosed significant physical illness that interferes with sleep, such as cranial disease or trauma, cancer pain, unstable angina, uncontrolled cardiac insufficiency and severe respiratory distress due to various causes, etc.
• Current or previous treatment with cognitive behavior therapy for insomnia (CBT-I).
• Not signed informed consent.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Shenzhen Zeen Health Technology Co., Ltd.: collaborator

Study Sites (1)

Jing Ma

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (1)

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Breast Neoplasms

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro.

Model Details: The enrolled breast cancer survivors were randomized into two groups: the intervention group was the dCBT-I treatment group and the control group was the wait-for-treatment group.

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: April 14, 2023
• Study Start: August 29, 2023
• Primary Completion: August 29, 2025
• Study Completion (Estimated): August 29, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

CN (1)