Clinical trial NCT06054256: Effects of Digitally Delivered and Group-based CBT-I in Pregnant Women With Comorbid Insomnia and Depression
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Depression
Insomnia
Keywords: Depression
Insomnia
Antenatal
Cognitive behavioural therapy
Pregnancy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Chinese University of Hong Kong
First posted: 2023-09-26
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (e.g., 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 Cohen's d ranging from 0.69 to 0.8) as compared to a control intervention (e.g., 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 6/at the conclusion of last session). Subjects will be also assessed for their sleep and mood symptoms at week 2/at the conclusion of session 2 and week 4/at 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.

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.

Primary outcomes:
measure: Change of insomnia symptoms
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at the conclusion of session 2 and 4, postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of depressive symptoms
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at the conclusion of session 2 and 4, postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Secondary outcomes:
measure: Change of pregnancy anxiety
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of pregnancy stress
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of self-report emotional states of depression, anxiety and stress
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of suicidal ideation
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of sleep quality
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of sleep diary measure (time in bed, TIB)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of sleep diary measure (total sleep time, TST)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of sleep diary measure (sleep onset latency, SOL)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of sleep diary measure (wake after sleep onset, WASO)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of sleep diary measure (sleep efficiency, SE)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of objective sleep measure (time in bed, TIB)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of objective sleep measure (total sleep time, TST)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of objective sleep measure (sleep onset latency, SOL)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of objective sleep measure (wake after sleep onset, WASO)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of objective sleep measure (sleep efficiency, SE)
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of dysfunctional beliefs and attitudes about sleep
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of pre-sleep arousal
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of sleep reactivity
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of sleep hygiene and practice
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of daytime sleepiness
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of subjective cognitive performance
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of daytime fatigue
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of quality of life
timeFrame: Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
measure: Change of postpartum mother-infant-relationship
timeFrame: Postpartum 3-month, 6-month and 12-month for those in the two active treatment groups.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Shirley Xin Li, Dr
role: PRINCIPAL_INVESTIGATOR
References: