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NCT Number: NCT06672432

Preventing Perinatal Depression with an App-Based CBT Program

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.

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Key information

Conditions

Perinatal Depression Disease Prevention

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program)

Other

The intervention is divided into daily tasks spread across eight weeks, with each day involving a variety of interactive elements such as videos, text-based content, guided reflections, and mental health check-ins. If the user misses a daily challenge, she can complete that challenge in the later days. Each week has a distinct focus that progressively builds the user's skills and understanding in managing emotional health. Tasks are designed to be short yet impactful, aiming to enhance engagement and adherence.

Matched Attention Control (a mobile app-based 8-week online relaxation training program)

Other

This program is designed to mirror the structure and engagement level of the intervention group, providing participants with a similar amount of interaction and daily activities. Each day, participants in the control group will complete 1-2 daily tasks focused on relaxation techniques, such as breathing exercises, mindfulness meditation, and guided imagery. Each task is brief, approximately 3 minutes in duration, making it easy for participants to incorporate into their daily routine.

Primary outcomes

  1. Changes in depression score at 6 weeks postpartum

    Time frame: From enrollment to 6 weeks postpartum

    Changes in Edinburgh Postnatal Depression Scale (EPDS) score. EPDS consists of 10 items rated on a four-point scale from 0 to 3, with a maximum score of 30, where higher scores indicate more severe depressive symptoms. We will use the Chinese version of EPDS in this study.

  2. Changes in depression score at 6 weeks postpartum

    Time frame: From enrollment to 6 weeks postpartum

    Changes in Patient Health Questionnaire-9 (PHQ-9) score.The total scores of PHQ-9 range from 0 to 27, with a score of 10 or greater being the most common cut-off for screening major depressive disorder. We will use the Chinese version of the PHQ-9 in this study.

  3. Changes in anxiety score at 6 weeks postpartum

    Time frame: From enrollment to 6 weeks postpartum

    Changes in Generalized Anxiety Disorder 7-item (GAD-7) score. GAD-7 consists of seven items, each rated on a score from 0 to 3. The total score ranges from 0 to 21, with higher scores reflecting more severe anxiety symptoms. In our study, the Chinese version of GAD-7 is applied.

Secondary outcomes

  1. Changes in depression score at post-intervention

    Time frame: From enrollment to the end of intervention at 8 weeks

    Changes in Edinburgh Postnatal Depression Scale (EPDS) score. EPDS consists of 10 items rated on a four-point scale from 0 to 3, with a maximum score of 30, where higher scores indicate more severe depressive symptoms. We will use the Chinese version of EPDS in this study.

  2. Changes in depression score at post-intervention

    Time frame: From enrollment to the end of intervention at 8 weeks

    Changes in Patient Health Questionnaire-9 (PHQ-9) score.The total scores of PHQ-9 range from 0 to 27, with a score of 10 or greater being the most common cut-off for screening major depressive disorder. We will use the Chinese version of the PHQ-9 in this study.

  3. Changes in anxiety score at post-intervention

    Time frame: From enrollment to the end of intervention at 8 weeks

    Changes in Generalized Anxiety Disorder 7-item (GAD-7) score. GAD-7 consists of seven items, each rated on a score from 0 to 3. The total score ranges from 0 to 21, with higher scores reflecting more severe anxiety symptoms. In our study, the Chinese version of GAD-7 is applied.

  4. Comparisons of satisfaction level

    Time frame: From enrollment to the end of intervention at 8 weeks

    Comparisons of Client Satisfaction Questionnaire (CSQ-8) results between the two groups. CSQ-8 consists of 8 items, resulting in scores that range from 8 to 32, with each item evaluated on a Likert scale; higher scores reflect greater levels of satisfaction.

  5. Comparisons of adverse events

    Time frame: From enrollment to the end of intervention at 8 weeks

    Comparisons of adverse events between the two groups

Study contacts

Contact information is provided by the study sponsor or research team.

Chunrong Li, PhD

CONTACT

[email protected]

+8618084859927

Sponsors and collaborators

Lead sponsor

Jintang County Maternal and Child Health Hospital

Other

Collaborators

  • Chengdu Women's and Children's Central Hospital

Registry information

Official study title

Preventing Perinatal Depression Using an App-based Cognitive Behavioral Therapy Program

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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