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Mindfulness for Perinatal Distress

NCT07757243 — Not applicable, Completed, 356 participants, Shenzhen Kangning Hospital

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Group Mindfulness Intervention for Negative Emotions in Pregnant Women and Its Effect on Attentional Bias to Pain Cues

RegistryNCT07757243
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment356 (Actual)
SponsorShenzhen Kangning Hospital (Other); collaborators: Shenzhen Luohu District Maternal and Child Health Hospital
ConditionsPerinatal Anxiety
InterventionsGroup Mindfulness Intervention, Group Discussion, Routine Health Education (Behavioral)
Datesstart 2021-09-21, primary completion 2022-10-01, completion 2022-10-01, first posted 2026-08-11, last updated 2026-09-11
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Group Mindfulness InterventionExperimentalBehavioral: Group Mindfulness InterventionParticipants 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.
Group DiscussionActive comparatorBehavioral: Group DiscussionParticipants attended an 8-week offline group discussion program in groups of 12 to 20, with one 60-minute session each week.
Health EducationActive comparatorBehavioral: Routine Health EducationParticipants received routine outpatient health education once weekly for 8 weeks, with each session lasting approximately 15 to 20 minutes.
  • Group Mindfulness Intervention (Behavioral): 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 Discussion (Behavioral): 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.
  • Routine Health Education (Behavioral): 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.

+Outcome measures

Primary outcomes

  • Change in anxiety symptoms [Baseline and immediately after the 8-week intervention]: Self-Rating Anxiety Scale (SAS) Anxiety symptoms were assessed using the 20-item Zung Self-Rating Anxiety Scale (SAS). Each item is rated from 1 to 4. The raw total score ranges from 20 to 80 and is multiplied by 1.25 and rounded to obtain a standard score ranging from 25 to 100. The minimum possible standard score is 25 and the maximum is 100. Higher scores indicate more severe anxiety symptoms. A standard score of 50 or higher indicates the presence of anxiety symptoms. The standard score was used in the analysis.
  • Change in depressive symptoms [Baseline and immediately after the 8-week intervention]: Self-Rating Depression Scale (SDS) Depressive symptoms were assessed using the 20-item Zung Self-Rating Depression Scale (SDS). Each item is rated from 1 to 4. The raw total score ranges from 20 to 80 and is multiplied by 1.25 and rounded to obtain a standard score ranging from 25 to 100. The minimum possible standard score is 25 and the maximum is 100. Higher scores indicate more severe depressive symptoms. A standard score of 53 or higher indicates the presence of depressive symptoms. The standard score was used in the analysis.
  • Change in fear of childbirth [Baseline and immediately after the 8-week intervention]: Childbirth Attitudes Questionnaire (CAQ) Fear of childbirth was assessed using the 16-item Childbirth Attitudes Questionnaire (CAQ). Each item is rated from 1 to 4, producing a total score ranging from 16 to 64. The minimum possible total score is 16 and the maximum is 64. Higher scores indicate greater fear of childbirth. Scores of 16-27 indicate no fear, 28-39 mild fear, 40-51 moderate fear, and 52-64 severe fear. A total score of 28 or higher indicates the presence of fear of childbirth. The total score was used in the analysis.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

FacilityCityCountryStatus
Shenzhen Kangning HospitalShenzhen, GuangdongChina

+Investigators

My Notes