Clinical trial NCT06672432: Preventing Perinatal Depression with an App-Based CBT Program
Official title: Preventing Perinatal Depression Using an App-based Cognitive Behavioral Therapy Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Depression
Disease Prevention
Keywords: Perinatal depression
cognitive behavioral therapy
iCBT
Lead sponsor: Jintang County Maternal and Child Health Hospital
Sponsor class: OTHER
Collaborators: name: Chengdu Women's and Children's Central Hospital
First posted: 2024-11-04
Enrollment: 290
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if CareMom, a mobile app-based cognitive behavioral therapy program works to prevent perinatal depression among Chinese mothers. The main questions the trial aims to answer are:

1. Does CareMom lower depression scores after an 8-week intervention?
2. Does CareMom lower depression scores at 6 weeks after childbirth?
3. How satisfied are participants with CareMom?
4. What unfavorable events, if any, are associated with the use of CareMom?

Researchers will compare CareMom to a matched attention control (a mobile app-based program that offers participants a similar level of interaction and daily activities) to see if CareMom works to prevent perinatal depression.

Participants will:

1. Engage in the CareMom program or a relaxation training program every day for 8 weeks
2. Complete a series of online questionnaire tests before and after the 8-week intervention.
3. Report any discomfort experienced throughout the study period.

Detailed description: A two-arm parallel randomised controlled trial of 290 pregnant women will be conducted at Jintang County Maternity and Child Health Hospital of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 20-24 weeks of gestation, and randomly allocated to either the intervention group (participate in a mobile app-based 8-week cognitive behavioral therapy program, named CareMom) or the control group (participate in a mobile app-based, attention-matched, 8-week relaxation training program) using a computer-generated random number. The primary outcomes are the changes in Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9) and 7-item Generalized Anxiety Disorder (GAD-7) scores from From enrollment to the end of intervention at 8 weeks.

Eligibility criteria: Inclusion Criteria:

* aged 18-45 years
* at 20-24 weeks of gestation
* at risk of depression but not experiencing severe depressive symptoms at recruitment, as indicated by an Edinburgh Postnatal Depression Scale (EPDS) score of between 5 and 12
* own a smartphone
* are able to independently engage with the program

Exclusion Criteria:

* have serious medical conditions or pregnancy complications that may affect their psychological condition, as determined by their medical doctor
* have a prior diagnosis of any mental disorders
* are currently or were recently (within the past six months) receiving any kinds of psychological services or treatments
* have a history of self-harm or suicide
* have any suicidal thoughts in the past 12 months
* experienced fetal deaths in the past 18 months

Primary outcomes:
measure: Changes in depression score at 6 weeks postpartum
timeFrame: From enrollment to 6 weeks postpartum
measure: Changes in depression score at 6 weeks postpartum
timeFrame: From enrollment to 6 weeks postpartum
measure: Changes in anxiety score at 6 weeks postpartum
timeFrame: From enrollment to 6 weeks postpartum
Secondary outcomes:
measure: Changes in depression score at post-intervention
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Changes in depression score at post-intervention
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Changes in anxiety score at post-intervention
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Comparisons of satisfaction level
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Comparisons of adverse events
timeFrame: From enrollment to the end of intervention at 8 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Jintang County Maternity and Child Health Hospital
state: Sichuan
Study officials:
References: