Pregnancy RelatedNCT06054256
Effects of Digitally Delivered and Group-based CBT-I in Pregnant Women With Comorbid Insomnia and Depression
A study testing Group CBT-I, App-based CBT-I and Health related psychoeducation in people with Pregnancy Related and Depression, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Major depressive disorder (MDD) is a debilitating and recurrent illness associated with a constellation of grave consequences and is among the most common psychiatric disorders during the pregnancy and postpartum periods. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Depression, Insomnia
- What is being tested?
- Group CBT-I, App-based CBT-I and Health related psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Jan 2022to 31 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above;
- 28-32 weeks of gestation at the entry of the study;
- Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥8;
- Having a DSM-5 diagnosis of depressive disorder as confirmed by the M.I.N.I. International Neuropsychiatric Interview (MINI) and with mild to moderate depressive symptoms (an Edinburgh Postnatal Depression Scale (EPDS) score ≥7 and ≤19);
- Singleton pregnancy;
- Being capable of providing informed consent.
Who cannot join
- Having a health-related high-risk factor, e.g., high blood pressure, diabetes, being HIV-positive, uncontrolled thyroid or seizure disorder;
- Having a clinically diagnosed sleep disorder (e.g., obstructive sleep apnoea, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep-wake disorders, parasomnias) based on the Diagnostic Interview for Sleep Patterns and Sleep Disorders (DISP), a validated semi-structured clinical interview for assessing major sleep disorders according to ICSD-2 criteria;
- Having a significant mental health condition, including posttraumatic stress disorder (current), panic disorder if associated with nocturnal panic attacks > 4 times in the past month, bipolar disorders, psychotic disorders, substance use disorders (during pregnancy);
- The subject, in the opinion of the investigator, has a significant risk of suicide, or has a suicidality level rated as moderate or above in the MINI Suicidality Module;
- Concurrent, regular use of medications or substance known to directly affect sleep quality and continuity (e.g., hypnotics, melatonin, steroids);
- Initiation of or change in antidepressant medication within past 2 months;
Show all 9Show fewer
- Ongoing pharmacologic or nonpharmacologic treatments for insomnia;
- Night shift worker;
- With hearing or speech deficit.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
Shirley Xin Li, Dr, +852 3917-7035, shirley.li@hku.hk
About this study
Official title: Efficacy of Digitally Delivered and Face-to-face Group Cognitive Behavioural Therapy for Insomnia in Pregnant Women With Comorbid Insomnia and Depression: A Randomised Controlled Trial
Major depressive disorder (MDD) is a debilitating and recurrent illness associated with a constellation of grave consequences and is among the most common psychiatric disorders during the pregnancy and postpartum periods. Meanwhile, sleep disturbance, particularly insomnia, is among the most prevalent and prominent presenting complaints in pregnant women with depression. Despite its high prevalence, insomnia often remains overlooked and under-treated in clinical practice. However, growing evidence suggests an intricate relationship between insomnia and depression, which has become an area in need of further focused attention. The optimal treatment for managing both antenatal depression and insomnia remains controversial. Only few pilot studies have evaluated the effects of cognitive behavioural therapy for insomnia (CBT-I) for antenatal insomnia. Whilst face-to-face CBT-I has shown the promise in managing insomnia in pregnant women, several barriers to implementation remain in clinical practice (e.g., a lack of trained therapists, long waiting time). Pregnant women also face additional unique barriers to obtaining insomnia treatment, including having other recurring prenatal health appointments, limitations in mobility or transportation, and financial concerns. There is growing evidence supporting the feasibility and comparable efficacy of digital CBT-I (effect size Cohen's d ranging from 0.69 to 0.8) as compared to a control intervention (e.g., sleep hygiene education, relaxation) for treating adult insomnia. However, little is known about the effects of different treatment modalities (group-based vs. app-based CBT-I) during pregnancy. This study aims to conduct a randomised controlled trial to examine the effects of group-based CBT-I and smartphone app-based CBT-I as compared to health education control condition in pregnant women with comorbid depression and insomnia on improving maternal sleep and depressive symptoms, other clinical and daytime symptoms, and overall functional improvement, as well as mother-infant-relationship.
Read the detailed description
A randomised parallel-group controlled trial will be conducted in pregnant women with comorbid insomnia and depression. Eligible subjects will be randomised to one of the following groups: group-based CBT-I + Usual care (UC), app-based CBT-I + UC, or health education + UC. Randomization will be performed using stratified blocked randomization, stratified by the severity of insomnia at baseline. Assessments will be conducted at baseline and post-treatment (week 6/at the conclusion of last session). Subjects will be also assessed for their sleep and mood symptoms at week 2/at the conclusion of session 2 and week 4/at the conclusion of session 4. Subjects in the control group will be offered CBT-I after post-intervention follow-up. Additional assessments will be conducted in the two active treatment groups at postpartum 3-month and 6-month. A further follow-up assessment will be scheduled at 12-month postpartum to particularly examine whether intervention effects can sustain over time in the two treatment groups.
- Conditions
- Pregnancy Related, Depression, Insomnia
- Being tested
- Group CBT-I, App-based CBT-I, Health related psychoeducation
- Keywords
- Depression, Insomnia, Antenatal, Cognitive behavioural therapy, Pregnancy
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CBT-IBehavioural
The group-based intervention will consist of 6 weekly sessions (90-min, 5-8 pregnant women in each group). The treatment components aim to address the behavioural, cognitive and physiological factors perpetuating insomnia with the followings: psycho-education about sleep and sleep hygiene (e.g., psychoeducation about sleep during pregnancy and normal development and patterns of infant sleep, psychoeducation on ways of improving infant sleep, strategies to limit the development of unwanted sleep associations, etc.), stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.
App-based CBT-IBehavioural
The smartphone app-based intervention will consist of 6 weekly sessions. The app-based intervention will involve a self-paced, fully automated digital programme with interactive components. The structure of the app involves six sequential modules (comparable to the six treatment sessions delivered in groups) with different elements to engage the users, such as animated videos, case vignettes, narration, quizzes, and homework assignment. Each module will be unlocked and released to the participants every week after the previous module has been completed. Personalised feedback will be provided by the app following the completion of sleep diary each week. Automated messages will be sent to the participants regularly via phone to remind them of implementing learned strategies after each module, as well as timely completing the treatment modules and sleep diaries.
Health related psychoeducationOther
The control group will receive 6 sessions of group-based health-related psychoeducation, a format that has been adopted in the previous research, in order to provide the credibility of the intervention to the participants, and to control for the potential effects of attention and nonspecific components.
| Study group | Role | What they receive |
|---|---|---|
| Group CBT-I | Experimental | The group CBT-I will receive 6-session group-based CBT-I. Receives: Behavioral: Group CBT-I |
| App-based CBT-I | Experimental | The app-based CBT-I group will receive 6-session CBT-I via smartphone. Receives: Behavioral: App-based CBT-I |
| Health-related psychoeducation control | Sham comparator | The control group will receive group-based health-related psychoeducation, a format that has been adopted in the previous research, in order to provide the credibility of the intervention to the participants, and to control for the potential effects of attention and nonspecific components, e.g., receiving health-related information, expectations of benefit. It will also consist of 6 weekly sessions which contain education on healthy diet, exercise habits, sleep hygiene and self-care specific to pregnancy, but will not include any active therapeutic components of CBT-I. Receives: Other: Health related psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of insomnia symptoms
Insomnia Severity Index (ISI) is a self-rated scale to assess the severity of insomnia symptoms. Possible scores range from 0 to 20, with higher scores indicating greater insomnia severity.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at the conclusion of session 2 and 4, postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of depressive symptoms
Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire used to assess the severity of depressive symptoms during both prenatal and postnatal periods. Possible scores range from 0 to 30, with higher scores indicating more serious depressive symptoms.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at the conclusion of session 2 and 4, postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Secondary outcomes (24)
Change of pregnancy anxiety
Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) is a 10-item self-report inventory to assess pregnancy anxiety. Possible scores range from 10 to 50, with higher scores indicating more serious pregnancy anxiety.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of pregnancy stress
Pregnancy Stress Rating Scale (PSRS) is a 36-item scale to measure psychological stress felt by women using a 5-point scale, ranging from never (1 point) to very extreme (5 points). A higher score indicates a higher stress level.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of self-report emotional states of depression, anxiety and stress
Depression Anxiety Stress Scales (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS scales contains 14 items. Higher scores suggest more depression, anxiety and stress, respectively.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of suicidal ideation
Depressive Symptom Inventory Suicidality Subscale (DSI-SS) is a 4-item self-rated scale measuring suicidal ideation. Possible total scores range from 0 to 12, with higher scores indicating higher suicidal ideation.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep quality
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (time in bed, TIB)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: time in bed (TIB) in hours.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (total sleep time, TST)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (sleep onset latency, SOL)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (SOL) in mins.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (wake after sleep onset, WASO)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (WASO) in mins.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (sleep efficiency, SE)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (time in bed, TIB)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: time in bed (TIB) in hours.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (total sleep time, TST)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: total sleep time (TST) in hours.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (sleep onset latency, SOL)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep onset latency (SOL) in mins.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (wake after sleep onset, WASO)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: wake after sleep onset (WASO) in mins.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (sleep efficiency, SE)
Actigraphic assessment for consecutive seven days. Sleep parameter estimated by wrist actigraphy: sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of dysfunctional beliefs and attitudes about sleep
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 16-item self-rated scale measuring the respondent's sleep-related beliefs, more specifically, their expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. A total score is calculated by averaging score of all items, possibly scored 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of pre-sleep arousal
Pre-Sleep Arousal Scale (PSAS) is a 16-item self-rated scale measuring pre-sleep arousal. There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40). In both cases, a higher score indicates higher pre-sleep arousal.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep reactivity
Ford Insomnia Response to Stress Test (FIRST) consists of 9 items designed to measure sleep reactivity. Possible scores range from 9 to 36. A higher score indicates higher sleep activity.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep hygiene and practice
Sleep Hygiene Practice Scale (SHPS) is a 30-item self-rated scale measuring sleep hygiene behaviors, ranging in total scores from 30 to 180, with higher scores indicating lower levels of sleep hygiene.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of daytime sleepiness
Epworth Sleepiness Questionnaire (ESS) is used to measure self-reported excessive daytime sleepiness (EDS). The total score of ESS ranges from 0 to 24, with higher scores indicating higher daytime sleepiness.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of subjective cognitive performance
Cognitive Failures Questionnaire (CFQ) is a 20-item self-rated scale measuring perceived failures in daily cognitive tasks. Possible total scores range from 0 to 80, with higher scores indicating higher cognitive failures.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of daytime fatigue
Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of quality of life
The Short Form 12 (SF-12) Health Related Quality of Life (HRQL) is a 12 item self-reported questionnaire to measure health related quality of life. A higher score on SF-12 represents a better health-related quality of life.
Measured: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of postpartum mother-infant-relationship
Mother-Infant Bonding Questionnaire (MIBQ) is a 8 item self-reported scale to assess maternal bonding of mothers with their babies during the postpartum period. Total scores range from 0 to 24. A high score indicates worse mother-to-infant bonding.
Measured: Postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start11 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Chinese University of Hong Kong
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
- Investigators
- Shirley Xin Li, Dr, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054256
- Sponsor's protocol ID
- EA220035
- Status last verified
- Dec 2023
- First submitted
- 19 Sep 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Digitally Delivered and Face-to-face Group Cognitive Behavioural Therapy for Insomnia in Pregnant Women With Comorbid Insomnia and Depression: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06054256
- Acronym / sponsor ID
- EA220035
- Conditions
- Pregnancy Related, Depression, Insomnia
- Keywords
- Depression, Insomnia, Antenatal, Cognitive behavioural therapy, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Stanford University, Chinese University of Hong Kong
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Sep 2023 (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.
Major depressive disorder (MDD) is a debilitating and recurrent illness associated with a constellation of grave consequences and is among the most common psychiatric disorders during the pregnancy and postpartum periods. Meanwhile, sleep disturbance, particularly insomnia, is among the most prevalent and prominent presenting complaints in pregnant women with depression. Despite its high prevalence, insomnia often remains overlooked and under-treated in clinical practice. However, growing evidence suggests an intricate relationship between insomnia and depression, which has become an area in need of further focused attention. The optimal treatment for managing both antenatal depression and insomnia remains controversial. Only few pilot studies have evaluated the effects of cognitive behavioural therapy for insomnia (CBT-I) for antenatal insomnia. Whilst face-to-face CBT-I has shown the promise in managing insomnia in pregnant women, several barriers to implementation remain in clinical practice (e.g., a lack of trained therapists, long waiting time). Pregnant women also face additional unique barriers to obtaining insomnia treatment, including having other recurring prenatal health appointments, limitations in mobility or transportation, and financial concerns. There is growing evidence supporting the feasibility and comparable efficacy of digital CBT-I (effect size Cohen's d ranging from 0.69 to 0.8) as compared to a control intervention (e.g., sleep hygiene education, relaxation) for treating adult insomnia. However, little is known about the effects of different treatment modalities (group-based vs. app-based CBT-I) during pregnancy. This study aims to conduct a randomised controlled trial to examine the effects of group-based CBT-I and smartphone app-based CBT-I as compared to health education control condition in pregnant women with comorbid depression and insomnia on improving maternal sleep and depressive symptoms, other clinical and daytime symptoms, and overall functional improvement, as well as mother-infant-relationship.
Detailed description
A randomised parallel-group controlled trial will be conducted in pregnant women with comorbid insomnia and depression. Eligible subjects will be randomised to one of the following groups: group-based CBT-I + Usual care (UC), app-based CBT-I + UC, or health education + UC. Randomization will be performed using stratified blocked randomization, stratified by the severity of insomnia at baseline. Assessments will be conducted at baseline and post-treatment (week 6/at the conclusion of last session). Subjects will be also assessed for their sleep and mood symptoms at week 2/at the conclusion of session 2 and week 4/at the conclusion of session 4. Subjects in the control group will be offered CBT-I after post-intervention follow-up. Additional assessments will be conducted in the two active treatment groups at postpartum 3-month and 6-month. A further follow-up assessment will be scheduled at 12-month postpartum to particularly examine whether intervention effects can sustain over time in the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group CBT-I | Experimental | Behavioral: Group CBT-IThe group CBT-I will receive 6-session group-based CBT-I. |
| App-based CBT-I | Experimental | Behavioral: App-based CBT-IThe app-based CBT-I group will receive 6-session CBT-I via smartphone. |
| Health-related psychoeducation control | Sham comparator | Other: Health related psychoeducationThe control group will receive group-based health-related psychoeducation, a format that has been adopted in the previous research, in order to provide the credibility of the intervention to the participants, and to control for the potential effects of attention and nonspecific components, e.g., receiving health-related information, expectations of benefit. It will also consist of 6 weekly sessions which contain education on healthy diet, exercise habits, sleep hygiene and self-care specific to pregnancy, but will not include any active therapeutic components of CBT-I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or above;
- 28-32 weeks of gestation at the entry of the study;
- Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥8;
- Having a DSM-5 diagnosis of depressive disorder as confirmed by the M.I.N.I. International Neuropsychiatric Interview (MINI) and with mild to moderate depressive symptoms (an Edinburgh Postnatal Depression Scale (EPDS) score ≥7 and ≤19);
- Singleton pregnancy;
Key exclusion criteria (9 listed)
- Having a health-related high-risk factor, e.g., high blood pressure, diabetes, being HIV-positive, uncontrolled thyroid or seizure disorder;
- Having a clinically diagnosed sleep disorder (e.g., obstructive sleep apnoea, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep-wake disorders, parasomnias) based on the Diagnostic Interview for Sleep Patterns and Sleep Disorders (DISP), a validated semi-structured clinical interview for assessing major sleep disorders according to ICSD-2 criteria;
- Having a significant mental health condition, including posttraumatic stress disorder (current), panic disorder if associated with nocturnal panic attacks > 4 times in the past month, bipolar disorders, psychotic disorders, substance use disorders (during pregnancy);
- The subject, in the opinion of the investigator, has a significant risk of suicide, or has a suicidality level rated as moderate or above in the MINI Suicidality Module;
- Concurrent, regular use of medications or substance known to directly affect sleep quality and continuity (e.g., hypnotics, melatonin, steroids);
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 |
|---|---|---|
| Group CBT-IThe group-based intervention will consist of 6 weekly sessions (90-min, 5-8 pregnant women in each group). The treatment components aim to address the behavioural, cognitive and physiological factors perpetuating insomnia with the followings: psycho-education about sleep and sleep hygiene (e.g., psychoeducation about sleep during pregnancy and normal development and patterns of infant sleep, psychoeducation on ways of improving infant sleep, strategies to limit the development of unwanted sleep associations, etc.), stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. | Behavioural | Group CBT-I |
| App-based CBT-IThe smartphone app-based intervention will consist of 6 weekly sessions. The app-based intervention will involve a self-paced, fully automated digital programme with interactive components. The structure of the app involves six sequential modules (comparable to the six treatment sessions delivered in groups) with different elements to engage the users, such as animated videos, case vignettes, narration, quizzes, and homework assignment. Each module will be unlocked and released to the participants every week after the previous module has been completed. Personalised feedback will be provided by the app following the completion of sleep diary each week. Automated messages will be sent to the participants regularly via phone to remind them of implementing learned strategies after each module, as well as timely completing the treatment modules and sleep diaries. | Behavioural | App-based CBT-I |
| Health related psychoeducationThe control group will receive 6 sessions of group-based health-related psychoeducation, a format that has been adopted in the previous research, in order to provide the credibility of the intervention to the participants, and to control for the potential effects of attention and nonspecific components. | Other | Health-related psychoeducation control |
Primary outcome
Change of insomnia symptoms
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at the conclusion of session 2 and 4, postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Insomnia Severity Index (ISI) is a self-rated scale to assess the severity of insomnia symptoms. Possible scores range from 0 to 20, with higher scores indicating greater insomnia severity.
Change of depressive symptoms
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at the conclusion of session 2 and 4, postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire used to assess the severity of depressive symptoms during both prenatal and postnatal periods. Possible scores range from 0 to 30, with higher scores indicating more serious depressive symptoms.
24 secondary outcomes
Change of pregnancy anxiety
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of pregnancy stress
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of self-report emotional states of depression, anxiety and stress
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of suicidal ideation
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep quality
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (time in bed, TIB)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (total sleep time, TST)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (sleep onset latency, SOL)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (wake after sleep onset, WASO)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep diary measure (sleep efficiency, SE)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (time in bed, TIB)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (total sleep time, TST)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (sleep onset latency, SOL)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (wake after sleep onset, WASO)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of objective sleep measure (sleep efficiency, SE)
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of dysfunctional beliefs and attitudes about sleep
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of pre-sleep arousal
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep reactivity
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of sleep hygiene and practice
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of daytime sleepiness
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of subjective cognitive performance
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of daytime fatigue
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of quality of life
Time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Change of postpartum mother-infant-relationship
Time frame: Postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Shirley Xin Li, Dr principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group CBT-I, App-based CBT-I and Health related psychoeducation in people with Pregnancy Related and Depression, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 9 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Shirley Xin Li, Dr (+852 3917-7035, shirley.li@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of insomnia symptoms (time frame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at the conclusion of session 2 and 4, postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.). The study lists 2 primary outcomes in all. 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 3 Jan 2024.