Clinical trial NCT06685484: Feasibility of Modified Mindfulness Training on Antenatal Depression and Perceived Stress in Pregnant Women With Male Child Preference
Official title: A Study on the Feasibility of Modified Mindfulness Training Program (MMTP) to Address Antenatal Depression and Perceived Stress Among Pregnant Women Exhibiting Male Child Preference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antenatal Depression
Keywords: Mindfulness training
Antenatal depression
Male Child preference
Perceived Stress
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A feasibility trial using the ADAPT-ITT framework will randomly assign participants to two groups.
Primary purpose: TREATMENT

Brief summary: This study will assess the feasibility of a modified mindfulness training intervention aimed at reducing antenatal depression and perceived stress in pregnant women with male child preference. The findings aim to support mental health interventions in maternity care.

Detailed description: Utilizing the ADAPT-ITT framework, this study will tailor mindfulness-based interventions to address unique cultural stressors, particularly those affecting maternal mental health due to male child preference.

Eligibility criteria: Inclusion Criteria:

* Pregnant women in the first and second trimester
* Score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS)

Exclusion Criteria:

* Psychiatric illness history, use of psychiatric medication

Primary outcomes:
measure: Reduction in Antenatal Depression
timeFrame: Baseline assessment, immediately post-intervention (six weeks), and one-month follow-up.
measure: Reduction in Perceived Stress
timeFrame: Immediately post-intervention (after six weeks)
measure: Participant Satisfaction with the Modified Mindfulness Training Program
timeFrame: Immediately post-intervention (after six weeks)
measure: Acceptability of the Modified Mindfulness Training Program in a Clinical Setting
timeFrame: Immediately post-intervention (after six weeks)
measure: Follow-Up Effects on Coping Skills
timeFrame: One-month follow-up after intervention completion
measure: Follow-Up Effects on Resilience
timeFrame: One-month follow-up after intervention completion
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Qatar Hospital
state: Sindh
Study officials:
affiliation: Institute of Nursing Sciences, Khyber Medical University Peshawar
name: Dr Badil
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Nursing, Khyber Medical University Peshawar
name: Dr Najma Naz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Public Health and Social Science, Khyber Medical University Peshawar
name: Dr Khalid Rahman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayano G, Tesfaw G, Shumet S. Prevalence and determinants of antenatal depression in Ethiopia: A systematic review and meta-analysis. PLoS One. 2019 Feb 19;14(2):e0211764. doi: 10.1371/journal.pone.0211764. eCollection 2019.
citation: Guo J, Zheng A, He J, Ai M, Gan Y, Zhang Q, Chen L, Liang S, Yu X, Kuang L. The prevalence of and factors associated with antenatal depression among all pregnant women first attending antenatal care: a cross-sectional study in a comprehensive teaching hospital. BMC Pregnancy Childbirth. 2021 Oct 26;21(1):713. doi: 10.1186/s12884-021-04090-z.
citation: Yin X, Sun N, Jiang N, Xu X, Gan Y, Zhang J, Qiu L, Yang C, Shi X, Chang J, Gong Y. Prevalence and associated factors of antenatal depression: Systematic reviews and meta-analyses. Clin Psychol Rev. 2021 Feb;83:101932. doi: 10.1016/j.cpr.2020.101932. Epub 2020 Oct 25.
citation: Sikander S, Ahmad I, Bates LM, Gallis J, Hagaman A, O'Donnell K, Turner EL, Zaidi A, Rahman A, Maselko J. Cohort Profile: Perinatal depression and child socioemotional development ; the Bachpan cohort study from rural Pakistan. BMJ Open. 2019 May 5;9(5):e025644. doi: 10.1136/bmjopen-2018-025644.
citation: Tesfaye Y, Agenagnew L. Antenatal Depression and Associated Factors among Pregnant Women Attending Antenatal Care Service in Kochi Health Center, Jimma Town, Ethiopia. J Pregnancy. 2021 Feb 8;2021:5047432. doi: 10.1155/2021/5047432. eCollection 2021.