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

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

Interventions

BEHAVIORAL

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.

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.

OTHER

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.

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• Chinese University of Hong Kong

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Shirley Xin Li, Dr · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-11

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Hong Kong

Study Locations