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Completed

NCT Number: NCT07757243

Mindfulness for Perinatal Distress

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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Key information

Conditions

Perinatal Anxiety Behavior Behavioral Symptoms Depression

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Kangning Hospital

Shenzhen, Guangdong, 518020, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in anxiety symptoms

    Time frame: 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.

  2. Change in depressive symptoms

    Time frame: 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.

  3. Change in fear of childbirth

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shenzhen Kangning Hospital

Other

Collaborators

  • Shenzhen Luohu District Maternal and Child Health Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 11, 2026
Registry last updated
Sep 11, 2026

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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