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

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia in Breast Cancer Survivors, A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: Digital Cognitive Behavioral Therapy for Insomnia

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Jing Ma
      • Contact: Jing Ma, Dr.; Phone Number: +861013651357974; Email: majjmail@163.com
      • Contact: Cheng Zhang, PhD; Email: chengzhang@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Breast cancer diagnosed within 5 years
3. 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.
4. 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.
5. ISI score ≥12.
6. Other sleep or psychiatric disorders, if present, must be stable and require no medication.
7. 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.
8. Sign the informed consent form. -

Exclusion Criteria:

1. New breast cancer progression, recurrence, or metastasis within 3 months, requiring new radiotherapy or immunotherapy regimen
2. Expected survival <12 months due to all causes
3. 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.
4. 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.
5. Current or previous treatment with cognitive behavior therapy for insomnia (CBT-I).
6. Not signed informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dCBT-I group; 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; a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP
No Intervention: the wait-list group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The insomnia severity index (ISI) scores	immediately post-treatment
The insomnia severity index (ISI) scores	3-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The insomnia severity index (ISI) scores		6-months follow-up
Online sleep diary measures	Online sleep diary measures（total sleep time, sleep efficiency, sleep latency, numbers and duration of awakenings during sleep)	up to 6-months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Scale (GAD-7)	The GAD-7 is a simple and reliable anxiety screening tool. There are a total of seven questions with a score of 0-3 for each question. The total score provides a possible score from 0-21. A score of 10 or greater indicates further evaluation is required.	up to 6-months follow-up
Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a simple and validated self-assessment scale for depressive disorders, with good reliability and validity both as an aid to the diagnosis of depression and in the assessment of symptom severity. It has a total of nine items with a total score of 0-27.	up to 6-months follow-up
the Short-Form 12 Health Survey (SF-12)	The SF-12 is a simplified version of the quality of life questionnaire generated based on the SF-36 scale, consisting of 12 items, containing eight dimensions, and assessing an individual's perceived physical and mental health status. The scale is scored on a percentage scale, and after obtaining a crude score, it is converted using the standardized scoring method. It includes the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Higher scores indicate higher levels of quality of survival. 7)The smart bracelet data (recording parameters such as bedtime, sleep duration, number of awakenings during sleep, wake-up time, and sleep quality)	up to 6-months follow-up
Pittsburgh sleep quality index (PSQI)		up to 6-months follow-up
the Functional Assessment of Cancer Therapy-Breast plus Arm morbidity (FACT-B + 4)		up to 6-months follow-up
EORTC Quality of Life Questionnaire (QLQ)-30	EORTC: The European Organization for Research and Treatment of Cancer; QOL-C30: Quality of Life Questionnaire Core 30.	up to 6-months follow-up

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Shenzhen Zeen Health Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Estimated): August 29, 2025
• Study Completion (Estimated): August 29, 2026

Study Registration Dates

• First Submitted: December 17, 2022
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; Insomnia; Cognitive Behaviour Therapy for insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2022-376

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No