Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)NCT05395546
Digital Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia
A study testing dCBT-I in people with Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), run by Women's Hospital School Of Medicine Zhejiang University.
Trial summary
Insomnia symptoms are common during pregnancy, especially in the second and third trimesters, which can reach more than 68%. Insomnia during pregnancy is not only associated with increased risk of preeclampsia, gestational diabetes, preterm labor, and cesarean section, but also increased postpartum poor sleep and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
- What is being tested?
- dCBT-I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40 years old
- 20-32 weeks of pregnancy, singleton pregnancy and regular obstetric examination at Zhejiang University Women's Hospital
- There has been a high frequency of insomnia symptoms
- According to the preliminary assessment by the project team, it meets the diagnostic criteria for insomnia
- Possess a smart phone and can operate it proficiently, with normal reading and writing comprehension ability, clear consciousness, and able to cooperate with the research to complete the questionnaire independently.
Who cannot join
- Assess the risk of preterm birth and concurrent pregnancy-related diseases;
- Completion of the 7-day sleep diary in the baseline period < 4 days;
- Combined with severe anxiety/depression;
- Suicidal tendencies or severe mental illness (bipolar disorder, schizophrenia, paranoid psychosis, etc.);
- Edinburgh Pregnancy Depression Scale (EPDS) total score ≥ 15;
- Have drug dependence or have taken anti-anxiety, anti-depression, sedative or hypnotic drugs for mental diseases within the past 3 months;
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- Participated in interventions such as meditation courses, childbirth yoga or cognitive behavioral therapy in the past 1 year;
- Complicated with serious physical diseases such as heart failure and tumor;
- Combined with sleep disorders such as severe obstructive sleep apnea that require further evaluation and treatment;
- There is alcohol and cigarette dependence;
- Shift work;
- Severe visual or hearing impairment and unable to use mobile phones normally;
- Physical illness with unstable condition, or illness itself that may interfere with cognitive behavioral therapy for insomnia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Digital Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia During Pregnancy
Insomnia symptoms are common during pregnancy, especially in the second and third trimesters, which can reach more than 68%. Insomnia during pregnancy is not only associated with increased risk of preeclampsia, gestational diabetes, preterm labor, and cesarean section, but also increased postpartum poor sleep and postpartum depression. Cognitive behavioral therapy (CBT-I) and drug therapy for insomnia are the two main methods of insomnia treatment. Drug therapy is the more commonly used traditional treatment method, but there may be certain drug risks. Therefore, non-drug methods for Insomnia in pregnant women is much safer.
Cognitive-behavioral therapy for insomnia is a psychological therapy for insomnia. Compared with sedative-hypnotic drugs, its therapeutic effect is slow, but the curative effect is long-lasting, with less relapse after treatment and no invasive side effects. Multiple guidelines recommend it as first-line therapy for insomnia. And "Digital Cognitive Behavioral Therapy" (dCBT-I), is based on CBT-I, a therapy provided by the Internet and smartphones, which simulates face-to-face CBT-I in reality. It can provide more convenient medical services for the special group of pregnant women, improve sleep, improve mental symptoms, life treatment, and reduce the risk of adverse outcomes for mothers and children.
The Womens' Hospital, Zhejiang University School of Medicine is conducting a clinical study on "Digital Cognitive Behavioral Therapy (dCBT-I) for maternal Insomnia during pregnancy". The primary goal of this research project was to examine the efficacy of dCBT-I ("RuMian") in the treatment of maternal insomnia. "RuMian" is a fully automatic dCBT-I application developed in China, and subjects will use it for free.
- Being tested
- dCBT-I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCBT-IOther
Also called Device: smartphone
- Complete the evaluation of various scales and record a 7-day sleep diary before entering the group
- Receive a 6-week treatment after enrollment, insist on using the app every day (about 5-10 minutes), and receive regular follow-up from the project doctor
- Scale assessment needs to be completed at the end of treatment
- One month after the end of treatment, cooperate with relevant follow-up and complete the scale evaluation
| Study group | Role | What they receive |
|---|---|---|
| dCBT-I treatment group | Experimental | Not described Receives: Other: dCBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of "Insomnia Severity Index(ISI)"
Insomnia Severity Index(ISI),the minimum and maximum values are 0 and 28, and higher scores mean a worse outcome.
Measured: From before treatment to the end of treatment (an average of 42 days)
Secondary outcomes (8)
Change of "Pittsburgh Sleep Quality Index（PSQI）"
Pittsburgh Sleep Quality Index（PSQI）,the minimum and maximum values are 0 and 21, and higher scores mean a worse outcome.
Measured: From before treatment to the end of treatment (an average of 42 days)
Change of "sleep onset latency（SOL）"
simple questionnaire will be used to assess this outcome of sleep onset latency（SOL）
Measured: From before treatment to the end of treatment (an average of 42 days)
Change of "wake up after sleep onset(WASO)"
simple questionnaire will be used to assess this outcome of WASO
Measured: From before treatment to the end of treatment (an average of 42 days)
Change of "sleep efficiency（SE）"
combination of questionnaire and calculate will be used to assess this outcome of SE
Measured: From before treatment to the end of treatment (an average of 42 days)
Change of "Number of wake ups during the night"
Number of wake ups during the night
Measured: From before treatment to the end of treatment (an average of 42 days)
Change of "total sleep time（TST）"
total sleep time（TST）
Measured: From before treatment to the end of treatment (an average of 42 days)
Change of "Edinburgh Pregnancy Depression Scale（EPDS）"
Edinburgh Pregnancy Depression Scale（EPDS）,the minimum and maximum values are 0 and 30, and higher scores mean a worse outcome.
Measured: From before treatment to the end of treatment (an average of 42 days)
Change of "Self-rating Anxiety Scale（SAS）"
Self-rating Anxiety Scale（SAS）, the minimum and maximum values are 25 and 100, and higher scores mean a worse outcome.
Measured: From before treatment to the end of treatment (an average of 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395546
- Sponsor's protocol ID
- PRO2022-2213
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia During Pregnancy
- ClinicalTrials.gov ID
- NCT05395546
- Acronym / sponsor ID
- PRO2022-2213
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insomnia symptoms are common during pregnancy, especially in the second and third trimesters, which can reach more than 68%. Insomnia during pregnancy is not only associated with increased risk of preeclampsia, gestational diabetes, preterm labor, and cesarean section, but also increased postpartum poor sleep and postpartum depression. Cognitive behavioral therapy (CBT-I) and drug therapy for insomnia are the two main methods of insomnia treatment. Drug therapy is the more commonly used traditional treatment method, but there may be certain drug risks. Therefore, non-drug methods for Insomnia in pregnant women is much safer.
Cognitive-behavioral therapy for insomnia is a psychological therapy for insomnia. Compared with sedative-hypnotic drugs, its therapeutic effect is slow, but the curative effect is long-lasting, with less relapse after treatment and no invasive side effects. Multiple guidelines recommend it as first-line therapy for insomnia. And "Digital Cognitive Behavioral Therapy" (dCBT-I), is based on CBT-I, a therapy provided by the Internet and smartphones, which simulates face-to-face CBT-I in reality. It can provide more convenient medical services for the special group of pregnant women, improve sleep, improve mental symptoms, life treatment, and reduce the risk of adverse outcomes for mothers and children.
The Womens' Hospital, Zhejiang University School of Medicine is conducting a clinical study on "Digital Cognitive Behavioral Therapy (dCBT-I) for maternal Insomnia during pregnancy". The primary goal of this research project was to examine the efficacy of dCBT-I ("RuMian") in the treatment of maternal insomnia. "RuMian" is a fully automatic dCBT-I application developed in China, and subjects will use it for free.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dCBT-I treatment group | Experimental | Other: dCBT-I |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-40 years old
- 20-32 weeks of pregnancy, singleton pregnancy and regular obstetric examination at Zhejiang University Women's Hospital
- There has been a high frequency of insomnia symptoms
- According to the preliminary assessment by the project team, it meets the diagnostic criteria for insomnia
- Possess a smart phone and can operate it proficiently, with normal reading and writing comprehension ability, clear consciousness, and able to cooperate with the research to complete the questionnaire independently.
Key exclusion criteria (13 listed)
- Assess the risk of preterm birth and concurrent pregnancy-related diseases;
- Completion of the 7-day sleep diary in the baseline period < 4 days;
- Combined with severe anxiety/depression;
- Suicidal tendencies or severe mental illness (bipolar disorder, schizophrenia, paranoid psychosis, etc.);
- Edinburgh Pregnancy Depression Scale (EPDS) total score ≥ 15;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dCBT-IAlso: Device: smartphone1. Complete the evaluation of various scales and record a 7-day sleep diary before entering the group 2. Receive a 6-week treatment after enrollment, insist on using the app every day (about 5-10 minutes), and receive regular follow-up from the project doctor 3. Scale assessment needs to be completed at the end of treatment 4. One month after the end of treatment, cooperate with relevant follow-up and complete the scale evaluation | Other | dCBT-I treatment group |
Primary outcome
Change of "Insomnia Severity Index(ISI)"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Insomnia Severity Index(ISI),the minimum and maximum values are 0 and 28, and higher scores mean a worse outcome.
8 secondary outcomes
Change of "Pittsburgh Sleep Quality Index（PSQI）"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "sleep onset latency（SOL）"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "wake up after sleep onset(WASO)"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "sleep efficiency（SE）"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "Number of wake ups during the night"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "total sleep time（TST）"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "Edinburgh Pregnancy Depression Scale（EPDS）"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Change of "Self-rating Anxiety Scale（SAS）"
Time frame: From before treatment to the end of treatment (an average of 42 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing dCBT-I in people with Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), run by Women's Hospital School Of Medicine Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoxia Liang (+860571-87061501, xiaozaizai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of "Insomnia Severity Index(ISI)" (time frame: From before treatment to the end of treatment (an average of 42 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.