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

Launched by THE UNIVERSITY OF HONG KONG · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two types of therapy—group-based and smartphone app-based cognitive behavioral therapy for insomnia (CBT-I)—on pregnant women who are experiencing both insomnia and depression. The goal is to see which treatment helps improve sleep and mood better, compared to a health education program. Insomnia is a common issue for many pregnant women, especially those facing depression, but it often goes untreated. By exploring these different treatment options, the researchers hope to find effective ways to support mothers during pregnancy.

To participate in this study, women need to be at least 18 years old and between 28 to 32 weeks pregnant, and should have a diagnosis of insomnia and mild to moderate depression. However, those with certain health conditions, severe sleep disorders, or significant mental health issues may not be eligible. If you join the study, you can expect to receive either the group therapy, the app-based therapy, or health education, and you'll be monitored for improvements in your sleep, mood, and overall well-being. This research aims to provide valuable insights into treating insomnia and depression during pregnancy, ultimately benefiting both mothers and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 or above;
• • 2. 28-32 weeks of gestation at the entry of the study;
• • 3. Having a DSM-5 diagnosis of insomnia disorder and with a score on Insomnia Severity Index (ISI) ≥8;
• • 4. 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);
• • 5. Singleton pregnancy;
• • 6. Being capable of providing informed consent.
• Exclusion Criteria:
• • 1. Having a health-related high-risk factor, e.g., high blood pressure, diabetes, being HIV-positive, uncontrolled thyroid or seizure disorder;
• • 2. 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;
• • 3. 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);
• • 4. 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;
• • 5. Concurrent, regular use of medications or substance known to directly affect sleep quality and continuity (e.g., hypnotics, melatonin, steroids);
• • 6. Initiation of or change in antidepressant medication within past 2 months;
• • 7. Ongoing pharmacologic or nonpharmacologic treatments for insomnia;
• • 8. Night shift worker;
• • 9. With hearing or speech deficit.