Status:
UNKNOWN
Effects of Digitally Delivered and Group-based CBT-I in Pregnant Women With Comorbid Insomnia and Depression
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Stanford University
Chinese University of Hong Kong
Conditions:
Pregnancy Related
Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
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 an...
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...
Eligibility Criteria
Inclusion
- Age 18 or above;
- 28-32 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06054256
Start Date
January 11 2022
End Date
December 31 2025
Last Update
January 3 2024
Active Locations (1)
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1
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong