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

NCT06054256 | Unknown

• 1 other identifier: EA220035
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Depression; Insomnia

Keywords

Depression; Insomnia; Antenatal; Cognitive behavioural therapy; Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (3)

Group CBT-I

EXPERIMENTAL

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

Behavioral: Group CBT-I

App-based CBT-I

EXPERIMENTAL

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

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.

Other: Health related psychoeducation

Interventions

Group CBT-I 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.

Group CBT-I

App-based CBT-I 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.

App-based CBT-I

Health related psychoeducation 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.

Health-related psychoeducation control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above;
• 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.

You may not qualify if:

• 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;
• Ongoing pharmacologic or nonpharmacologic treatments for insomnia;
• Night shift worker;
• With hearing or speech deficit.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Stanford University: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Shirley Xin Li, Dr

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Xin Li, Dr

CONTACT

+852 3917-7035; shirley.li@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: January 11, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)