Perinatal AnxietyNCT07757243
Mindfulness for Perinatal Distress
A study testing Group Mindfulness Intervention, Group Discussion and Routine Health Education in people with Perinatal Anxiety, run by Shenzhen Kangning Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Anxiety
- What is being tested?
- Group Mindfulness Intervention, Group Discussion and Routine Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group Mindfulness Intervention for Negative Emotions in Pregnant Women and Its Effect on Attentional Bias to Pain Cues
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.
- Conditions
- Perinatal Anxiety
- Being tested
- Group Mindfulness Intervention, Group Discussion, Routine Health Education
- Keywords
- Pregnancy, Mindfulness, Depressive Symptoms, Fear of Childbirth, Pain-Related Attention, Dot-Probe Task
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Mindfulness InterventionBehavioural
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 DiscussionBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Routine Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety symptoms
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.
Measured: Baseline and immediately after the 8-week intervention
Change in depressive symptoms
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.
Measured: Baseline and immediately after the 8-week intervention
Change in fear of childbirth
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.
Measured: Baseline and immediately after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start21 Sep 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Luohu District Maternal and Child Health Hospital
- Responsible party
- Principal investigator, Jingchu Hu, Shenzhen Kangning Hospital
- Investigators
- Jingchu Hu, Dr., Principal investigator, Shenzhen Kangning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757243
- Sponsor's protocol ID
- LL2021072261
- Other IDs
- JCYJ20230807142359032
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Mindfulness Intervention for Negative Emotions in Pregnant Women and Its Effect on Attentional Bias to Pain Cues
- ClinicalTrials.gov ID
- NCT07757243
- Acronym / sponsor ID
- LL2021072261
- Conditions
- Perinatal Anxiety
- Keywords
- Pregnancy, Mindfulness, Depressive Symptoms, Fear of Childbirth, Pain-Related Attention, Dot-Probe Task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Shenzhen Kangning HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Luohu District Maternal and Child Health Hospital
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Mindfulness Intervention | Experimental | Behavioral: 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 Discussion | Active comparator | Behavioral: Group DiscussionParticipants attended an 8-week offline group discussion program in groups of 12 to 20, with one 60-minute session each week. |
| Health Education | Active comparator | Behavioral: Routine Health EducationParticipants received routine outpatient health education once weekly for 8 weeks, with each session lasting approximately 15 to 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Mindfulness InterventionThe 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. | Behavioural | Group Mindfulness Intervention |
| Group DiscussionParticipants 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. | Behavioural | Group Discussion |
| Routine Health EducationParticipants 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. | Behavioural | Health Education |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Perinatal Anxiety
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Not yet recruiting
Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention
Perinatal Anxiety, Perinatal Depression
Recruiting
Deconstructing Maternal Burdens: Doulas and the Community Unite for Health
Pregnancy, Post Partum
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain
Recruiting
Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders
Perinatal Anxiety, Anxiety Sensitivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingchu Hu, Dr. principal investigator
Shenzhen Kangning Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Mindfulness Intervention, Group Discussion and Routine Health Education in people with Perinatal Anxiety, run by Shenzhen Kangning Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety symptoms (time frame: Baseline and immediately after the 8-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.