NCT07757243

Brief Summary

This randomized controlled intervention study evaluated an 8-week group mindfulness intervention for pregnant women at 20 to 30 gestational weeks. Participants were randomized to mindfulness-based group intervention, group discussion, or health education. The study assessed anxiety, depressive symptoms, and fear of childbirth before and after intervention, and an exploratory subsample completed a pain dot-probe task to examine pain-related attention processing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Perinatal Anxiety

Keywords

PregnancyMindfulnessDepressive SymptomsFear of ChildbirthPain-Related AttentionDot-Probe Task

Outcome Measures

Primary Outcomes (3)

  • Change in anxiety symptoms

    Self-Rating Anxiety Scale (SAS)

    Baseline and immediately after the 8-week intervention

  • Change in depressive symptoms

    Self-Rating Depression Scale (SDS)

    Baseline and immediately after the 8-week intervention

  • Change in fear of childbirth

    Childbirth Attitudes Questionnaire (CAQ)

    Baseline and immediately after the 8-week intervention

Study Arms (3)

Group Mindfulness Intervention

EXPERIMENTAL

Participants received an 8-week offline group mindfulness intervention in groups of 12 to 20. Sessions were conducted once weekly for 60 minutes by trained psychiatrists or psychological counseling professionals.

Behavioral: Group Mindfulness Intervention

Group Discussion

ACTIVE COMPARATOR

Participants attended an 8-week offline group discussion program in groups of 12 to 20, with one 60-minute session each week.

Behavioral: Group Discussion

Health Education

ACTIVE COMPARATOR

Participants received routine outpatient health education once weekly for 8 weeks, with each session lasting approximately 15 to 20 minutes.

Behavioral: Routine Health Education

Interventions

Group Mindfulness InterventionBEHAVIORAL

The intervention consisted of eight weekly 60-minute offline group sessions. Each group included 12 to 20 participants. Sessions covered mindfulness theory, mindful breathing, body scan, mindful eating, sitting meditation, walking meditation, mindful stretching, and group reflection. The intervention was delivered by psychiatrists or psychological counseling professionals trained in mindfulness.

Group Mindfulness Intervention
Group DiscussionBEHAVIORAL

Participants attended eight weekly 60-minute offline group discussion sessions. Discussion topics included physical changes during pregnancy, emotional experiences, concerns about childbirth, and adaptation to daily life. The facilitator maintained group order and timing but did not provide structured psychological techniques or professional psychological guidance.

Group Discussion
Routine Health EducationBEHAVIORAL

Participants received routine outpatient health education once weekly for 8 weeks. Each session lasted approximately 15 to 20 minutes and covered antenatal health care, precautions for prenatal visits, diet, and rest. No group psychological intervention was provided.

Health Education

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant woman
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women at 20 to 30 gestational weeks.
  • No obvious pregnancy complications.
  • Able to complete questionnaires independently.
  • Willing to participate in the study and able to complete the 8-week intervention.
  • Provided written informed consent.

You may not qualify if:

  • Self-harm behavior or suicidal tendency.
  • Current psychiatric medication use.
  • Severe mental disorder, such as schizophrenia, bipolar disorder, or organic mental disorder.
  • Severe somatic disease, such as abnormal liver or renal function, brain injury, heart disease, or epilepsy.
  • Pregnancy complications or expected inability to complete the intervention or follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Kangning Hospital

Guangzhou, Guangdong, 518020, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jingchu Hu, Dr.

    Shenzhen Kangning Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

September 21, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

August 11, 2026

Record last verified: 2026-07

Locations

CN(1)