Mindfulness in pregnancy study
| ISRCTN | ISRCTN11175222 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11175222 |
| Sponsor | UCI Health Susan Samueli Integrative Health Institute |
| Funder | UCI Susan Samueli Integrative Health Institute |
- Submission date
- 26/06/2026
- Registration date
- 01/07/2026
- Last edited
- 30/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The purpose of this research study is to compare the feasibility and acceptability of two mindfulness courses [mindfulness-based stress reduction (MBSR) and mindful self-compassion (MSC)] among pregnant women. The study will also wish to understand if the mindfulness courses change maternal mental well-being and levels of blood sugars and inflammation during pregnancy.
Who can participate?
English-speaking adults pregnant with one baby are eligible to participate.
What does the study involve?
Participation involves an 8 week standardized mindfulness course delivered virtually with each class lasting 2.5 hours. Participants will complete surveys about their background, mood/mental health states and dietary intake, and have a small blood draw taken before and after the 8-week mindfulness course.
What are the possible benefits and risks of participating?
Benefits of participation include receiving a guided mindfulness training from a qualified instructor free of charge. Participants will be provided with mindfulness audio and written materials that you may keep for ongoing home practice.
There may be direct benefits of the MBSR and MSC techniques practiced during the study, such as:
increased awareness and concentration, discovering new ways to cope more effectively with existing conditions, psychological difficulties, pain or suffering, learning to take better care of oneself. However, there is no guarantee that any particular results from participation in either MBSR or MSC courses.
Risks of participation include discomfort, stress or anxiety when completing some questionnaires and during the mindfulness course. There is a small risk of temporary pain, bruising, bleeding or swelling from blood draw in your forearm. Also, should there be a breach in confidentiality of your data, there is a slight risk that your private information could be shared with individuals who are not members of the study team.
Where is the study run from?
UCI Susan Samueli Integrative Health Institute, USA.
When is the study starting and how long is it expected to run for?
August 2021 to December 2021.
Who is funding the study?
UCI Susan Samueli Integrative Health Institute, USA.
Who is the main contact?
Dr Karen Lindsay, kllindsa@uci.edu
Contact information
Principal investigator, Scientific, Public
856 Health Sciences Rd
Irvine
92617
United States of America
| Phone | +1 9498240148 |
|---|---|
| kllindsa@uci.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Health services research, Supportive care |
| Scientific title | Identifying an optimal mindfulness intervention for pregnant women: a feasibility and acceptability study |
| Study objectives | To compare the feasibility and acceptability of two mindfulness courses [mindfulness-based stress reduction (MBSR) and mindful self-compassion (MSC)] among pregnant women. To explore if participation in either of the mindfulness courses is associated with a change in maternal mental well-being and levels of blood sugars and inflammation during pregnancy. |
| Ethics approval(s) |
Approved 21/05/2021, University of California Irvine Institutional Review Board (Aldrich Hall, Irvine, 92617, United States of America; +1 (949) 824-6068; IRB@research.uci.edu), ref: 2021-6552 |
| Health condition(s) or problem(s) studied | Singleton pregnancy |
| Intervention | Overview: Participants are randomized to one of two types of mindfulness courses, both lasting 8 weeks and delivered virtually over Zoom with a trained mindfulness instructor. For each course, weekly sessions last 2.5 hours. Course types: - mindfulness-based stress reduction (MBSR) - mindful self-compassion (MSC) Both courses also include a half-day retreat delivered online. In depth: • Method of randomization: A computer program was used to generate the random allocation sequence for the two mindfulness groups. The sequence was stored in an Excel file by a researcher who was not involved in delivering the intervention. This individual revealed each participant’s group allocation as they were enrolled in the study • Intervention: o MBSR: Those assigned to the Mindfulness Based Stress Reduction group underwent this 8-week standardized mindfulness course as developed by John Kabat-Zinn. Participants met as a group virtually by Zoom once per week for 8 weeks. Each session lasted between 2-2.5 hours and was scheduled for the same evening each week. A mindfulness instructor trained in the MBSR method led each class and participants were assigned mindfulness practices and reflections to complete at home between classes. Additionally, the instructor led a 6-hour mindfulness retreat on a weekend between weeks 6 and 7, per the standardized curriculum for MBSR. o MSC: Those assigned to the Mindful Self Compassion group underwent this 8-week standardized mindfulness course as developed by Kristin Neff. Participants met as a group virtually by Zoom once per week for 8 weeks. Each session lasted between 2-2.5 hours and was scheduled for the same evening each week. A mindfulness instructor trained in the MSC method led each class and participants were assigned self-compassion practices and reflections to complete at home between classes. Additionally, the instructor led a 4-hour mindfulness retreat on a weekend between weeks 6 and 7, per the standardized curriculum for MSC. o The same instructor led each course. The instructor was not involved in the study design, data collection, or data analysis. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 20/12/2021 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 30 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1. >18 years age 2. Currently pregnant with one baby (no twins, triplets, etc.) 3. Between 14-27 weeks pregnant 4. Access to a computer, tablet or laptop with internet access |
| Key exclusion criteria | 1. Diagnosed with a major obstetric complication (congenital malformations/ fetal chromosomal abnormalities, placenta abruption, preeclampsia, or severe systemic/local infection) 2. Taking steroid medication 3. Receiving treatment (medication or other therapy) for a psychiatric condition 4. Non-fluent in English 5. Previously completed formal mindfulness training of any type 6. Unwilling/unable to attend the full course sessions over 8 weeks |
| Date of first enrolment | 08/08/2021 |
| Date of final enrolment | 15/09/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
29/06/2026: Study’s existence confirmed by the University of California Irvine Institutional Review Board, USA.
