Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054256
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-09-19
Brief Title:
Effects of Digitally Delivered and Group-based CBT-I in Pregnant Women With Comorbid Insomnia and Depression
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 Cohens d ranging from 069 to 08 as compared to a control intervention eg 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 6at the conclusion of last session Subjects will be also assessed for their sleep and mood symptoms at week 2at the conclusion of session 2 and week 4at 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None