Effects of digital and group CBT for insomnia and depression in pregnant women

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

This study is testing whether group therapy or an app for treating insomnia can help pregnant women who also have depression feel better and sleep more soundly.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The University of Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06054256 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of group-based and app-based cognitive behavioral therapy for insomnia (CBT-I) in pregnant women suffering from both insomnia and depression. Participants will be randomly assigned to receive either group CBT-I combined with usual care, app-based CBT-I with usual care, or health education with usual care. Assessments will be conducted at various intervals to evaluate changes in sleep and mood symptoms, with follow-ups extending into the postpartum period to assess the sustainability of treatment effects. The study aims to address the often-overlooked issue of insomnia in pregnant women with depression.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18 and above, between 28-32 weeks of gestation, with diagnosed insomnia and mild to moderate depressive symptoms.

Not a fit: Patients with high-risk health factors or clinically diagnosed sleep disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective non-pharmacological treatment options for pregnant women dealing with insomnia and depression.

How similar studies have performed: While few pilot studies have explored CBT-I for antenatal insomnia, this approach remains relatively novel and under-tested in larger populations.

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.

Where this trial is running

Hong Kong

• Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Shirley Xin Li, Dr — The University of Hong Kong
• Study coordinator: Shirley Xin Li, Dr

Conditions: Pregnancy Related, Depression, Insomnia, Antenatal, Cognitive behavioural therapy, Pregnancy