Effects of Digitally Delivered and Group-based CBT-I in Pregnant Women With Comorbid Insomnia and Depression

NCT ID: NCT06054256

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Pregnancy Related; Depression; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group CBT-I

The group CBT-I will receive 6-session group-based CBT-I.

Group Type: EXPERIMENTAL

Group CBT-I

Intervention Type: BEHAVIORAL

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-I

The app-based CBT-I group will receive 6-session CBT-I via smartphone.

Group Type: EXPERIMENTAL

App-based CBT-I

Intervention Type: BEHAVIORAL

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 psychoeducation control

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.

Group Type: SHAM_COMPARATOR

Health related psychoeducation

Intervention Type: OTHER

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.

Interventions

Group CBT-I

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.

Intervention Type: BEHAVIORAL

App-based CBT-I

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.

Intervention Type: BEHAVIORAL

Health related psychoeducation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18 or above;

2. 28-32 weeks of gestation at the entry of the study;

3. Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥8;

4. 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);

5. Singleton pregnancy;

6. Being capable of providing informed consent.

Exclusion Criteria

1. Having a health-related high-risk factor, e.g., high blood pressure, diabetes, being HIV-positive, uncontrolled thyroid or seizure disorder;

2. 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;

3. 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);

4. 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;

5. Concurrent, regular use of medications or substance known to directly affect sleep quality and continuity (e.g., hypnotics, melatonin, steroids);

6. Initiation of or change in antidepressant medication within past 2 months;

7. Ongoing pharmacologic or nonpharmacologic treatments for insomnia;

8. Night shift worker;

9. With hearing or speech deficit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shirley Xin Li

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Xin Li, Dr

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shirley Xin Li, Dr

Role: CONTACT

shirley.li@hku.hk

+852 3917-7035

Facility Contacts

Shirley Xin Li, Dr

Role: primary

shirley.li@hku.hk

+852 3917-7035

Other Identifiers

EA220035

Identifier Type: -

Identifier Source: org_study_id