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

Chronic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05813392
• Other study ID #: 2022-376
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 16, 2023
• Est. completion date: August 2025

Study information

• Verified date: July 2023
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Digital Cognitive Behavioral Therapy for Insomnia
a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Shenzhen Zeen Health Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Pittsburgh sleep quality index (PSQI)		up to 6-months follow-up
Other	the Functional Assessment of Cancer Therapy-Breast plus Arm morbidity (FACT-B + 4)		up to 6-months follow-up
Other	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
Primary	The insomnia severity index (ISI) scores		immediately post-treatment
Primary	The insomnia severity index (ISI) scores		3-months follow-up
Secondary	The insomnia severity index (ISI) scores		6-months follow-up
Secondary	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