Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Chronic Graft Versus Host Disease

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

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.

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

Digital Cognitive Behavioral Therapy for Insomnia

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.

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.

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

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.

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.

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)

EORTC: The European Organization for Research and Treatment of Cancer; QOL-C30: Quality of Life Questionnaire Core 30.

Online sleep diary measures（total sleep time, sleep efficiency, sleep latency, numbers and duration of awakenings during sleep)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors	NCT05813392	Chronic Insomni...	Digital Cogniti...	18 Years -	Peking University First Hospital
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors	NCT05813392	Chronic Insomni...	Digital Cogniti...	18 Years -	Peking University First Hospital

Spots Global Cancer Trial Database for digital cognitive behavioral therapy for insomnia