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

Primary Purpose

Chronic Insomnia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Digital Cognitive Behavioral Therapy for Insomnia
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Cognitive Behaviour Therapy for insomnia, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. - Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    dCBT-I group

    the wait-list group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    The insomnia severity index (ISI) scores
    The insomnia severity index (ISI) scores

    Secondary Outcome Measures

    The insomnia severity index (ISI) scores
    Online sleep diary measures
    Online sleep diary measures(total sleep time, sleep efficiency, sleep latency, numbers and duration of awakenings during sleep)

    Full Information

    First Posted
    December 17, 2022
    Last Updated
    July 25, 2023
    Sponsor
    Peking University First Hospital
    Collaborators
    Shenzhen Zeen Health Technology Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05813392
    Brief Title
    Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors
    Official Title
    Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia in Breast Cancer Survivors, A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 16, 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University First Hospital
    Collaborators
    Shenzhen Zeen Health Technology Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Insomnia
    Keywords
    Insomnia, Cognitive Behaviour Therapy for insomnia, breast cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    264 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dCBT-I group
    Arm Type
    Experimental
    Arm Description
    The dCBT-I group will receive full self-help dCBT-I through a smartphone APP for 6 weeks.
    Arm Title
    the wait-list group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Digital Cognitive Behavioral Therapy for Insomnia
    Intervention Description
    a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP
    Primary Outcome Measure Information:
    Title
    The insomnia severity index (ISI) scores
    Time Frame
    immediately post-treatment
    Title
    The insomnia severity index (ISI) scores
    Time Frame
    3-months follow-up
    Secondary Outcome Measure Information:
    Title
    The insomnia severity index (ISI) scores
    Time Frame
    6-months follow-up
    Title
    Online sleep diary measures
    Description
    Online sleep diary measures(total sleep time, sleep efficiency, sleep latency, numbers and duration of awakenings during sleep)
    Time Frame
    up to 6-months follow-up
    Other Pre-specified Outcome Measures:
    Title
    Generalized Anxiety Scale (GAD-7)
    Description
    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.
    Time Frame
    up to 6-months follow-up
    Title
    Patient Health Questionnaire-9 (PHQ-9)
    Description
    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.
    Time Frame
    up to 6-months follow-up
    Title
    the Short-Form 12 Health Survey (SF-12)
    Description
    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)
    Time Frame
    up to 6-months follow-up
    Title
    Pittsburgh sleep quality index (PSQI)
    Time Frame
    up to 6-months follow-up
    Title
    the Functional Assessment of Cancer Therapy-Breast plus Arm morbidity (FACT-B + 4)
    Time Frame
    up to 6-months follow-up
    Title
    EORTC Quality of Life Questionnaire (QLQ)-30
    Description
    EORTC: The European Organization for Research and Treatment of Cancer; QOL-C30: Quality of Life Questionnaire Core 30.
    Time Frame
    up to 6-months follow-up

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. - Exclusion Criteria: 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.

    12. IPD Sharing Statement

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

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