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

NARecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

January 11, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Pregnancy RelatedDepressionInsomnia
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.

Trial Locations (1)

Unknown

RECRUITING

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

All Listed Sponsors
collaborator

Stanford University

OTHER

collaborator

Chinese University of Hong Kong

OTHER

lead

The University of Hong Kong

OTHER