StressEMMANCT05255380
Examine the Effects of Mindfulness in Woman With a History of Child Adversity
A study testing Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day and Mindful awareness and reporting of current thoughts and feelings, 2 times/day in people with Stress and Psychological Stress, run by University of California, San Francisco at 1 site in United States.
Trial summary
The aim of this pilot Randomized Controlled Trial (RCT) is to test whether brief mindfulness-based practices will improve well-being and health in women (age 30-50) with a history of early life adversity. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological Stress, Child Maltreatment
- What is being tested?
- Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day and Mindful awareness and reporting of current thoughts and feelings, 2 times/day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2022to 19 Apr 2024
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female sex and gender identity (to control for sex and gender differences in stress responses and health outcomes)
- age 30-50 (to examine intervention effects on health outcomes in midlife)
- ≥2 Adverse Childhood Experiences (to ensure exposure to early life adversity)
- mild depressive symptoms (to allow for outcome improvements: PHQ-9 ≥ 5)
- having a smartphone (to access app-based assessments/interventions)
Who cannot join
- Non-English speaker or unable to provide informed consent
- Current regular mindfulness practice (exclude if >20 min/week)
- Major psychiatric condition, including psychosis/schizophrenia, bipolar disorder, post-traumatic stress disorder, eating disorders, alcohol/substance use, major depression (PHQ-9 ≥ 15), and self-harm or suicidal ideation
- Major medical conditions, including no history of coronary heart disease, diabetes, severe asthma or lung disease, autoimmune disorders, infectious disease, epilepsy, brain injury, endocrine disorders, diagnosis of cancer or chemotherapy or radiation in the past 10 years
- Free from medications known to affect the immune and endocrine systems with the exception of antidepressant medication and oral contraceptives
- Psychotherapy treatment permitted if stable (≥3 months)
- Current smoking and nicotine use
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: Pilot Randomized Controlled Trial Examining the Effects of Daily Mindfulness in Woman With a History of Child Adversity
The aim of this pilot Randomized Controlled Trial (RCT) is to test whether brief mindfulness-based practices will improve well-being and health in women (age 30-50) with a history of early life adversity. Following a baseline visit (remotely via Zoom), participants are randomized (50% probability) to either a Mindful Activity group or a Mindful Awareness group. In the Mindful Activity group, participants will complete brief (approximately 5-10 min) audio-guided mindfulness practices twice a day (morning and evening) for 8 weeks using the study app. This is followed by a brief survey about their current thoughts and feelings. In the Mindful Awareness group, participants are asked to be mindful (pay attention) to their thoughts and feelings twice a day (morning and evening) for 8 weeks using the study app. After the 8-week intervention period, all participants complete a follow-up visit (remotely). Primary goals of the pilot RCT are to test acceptability, feasibility, and adherence.
Read the detailed description
The pilot Randomized Controlled Trial (RCT) randomly assigns midlife women (age 30-50) with a history of early life adversity to either a Mindful Activity group or a Mindful Awareness group to primarily test acceptability, feasibility, and adherence. Randomization will occur by chance at the end of the baseline visit.
Participants randomized to the Mindful Activity group will receive 8 weeks of ecological momentary assessment and intervention sessions via the study app. Mindfulness-based interventions consist of mindfulness and compassion-based practices. For example, practices focus on the breath/body (e.g., 3-minute breathing space; compassionate body scan; five senses mediation), on increasing participants' inner resources (e.g., imaging a safe person or safe place), on reducing negative affect (e.g., self-compassionate and acceptance-based practices), or on increasing positive emotions (e.g., gratitude practice; metta practices). All interventions are audio-guided and approximately 5-10 minutes. Participants complete two mindfulness interventions/day (one in the morning; one in the evening). After completing a mindfulness-based intervention, participants will complete ecological momentary assessments of their current psychological stress states (e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection) via the study app.
Participants randomized to the Mindful Awareness group are instructed to be mindful (pay attention) to their current thoughts and feelings and complete ecological momentary assessments of their current psychological stress states (e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection) twice/day (morning and evening) for 8 weeks via the study app.
A trained research assistant will monitor participant adherence and address potential difficulties. All participants will complete assessments at baseline (pre-intervention) and post-intervention (after the 8-week intervention). Weekly measures of depressive symptoms are also obtained. The investigators plan to consent about 100 participants with the goal of having 70 eligible participants enrolled in the study (about 35 in each group).
- Being tested
- Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day, Mindful awareness and reporting of current thoughts and feelings, 2 times/day
- Keywords
- Mindfulness, Adverse childhood experiences, Stress, Depressive symptoms
- Medical subject headings
- Stress, Psychological, Depression, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and compassion-based practices; approximately 5-10 minutes two times/dayBehavioural
The app-based (audio-guided) interventions consist of mindfulness and compassion-based practices that are selected to maximize their effect on stress targets. Interventions include, for example, practices that focus on the breath/body (e.g., 3-minute breathing space; compassionate body scan; five senses mediation), on increasing participants' inner resources (e.g., imaging a safe person or safe place), on reducing negative affect (e.g., self-compassion and acceptance-based practices), or on increasing positive emotions (e.g., gratitude practice; metta practices).
Mindful awareness and reporting of current thoughts and feelings, 2 times/dayBehavioural
Participants are instructed to be mindful (pay attention) to their current thoughts and feelings and complete ecological momentary assessments of their current psychological stress states (e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection)
| Study group | Role | What they receive |
|---|---|---|
| Mindful Activity group | Experimental | Participants complete mindfulness and compassion-based practices via the study app. Receives: Behavioral: Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day |
| Mindful Awareness group | Sham comparator | Participants monitor and report their thoughts and feelings via the study app. Receives: Behavioral: Mindful awareness and reporting of current thoughts and feelings, 2 times/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention will be measured with an adapted version of the Treatment Acceptability Questionnaire (TAQ).
The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view their assigned intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable), with a possible score range from 6 to 42. Higher scores indicate better treatment acceptability and positive perceptions of the treatment. A total mean score of at least 24 will indicate sufficient acceptability of the intervention.
Measured: Assessed at post-intervention, approximately 8 weeks from baseline
Feasibility, as indicated by numbers of participants screened (completed web-based screener and phone screener), eligible based on web-based screener and phone screener, consented, randomized to treatment, and retained at follow-up.
Feasibility outcomes will include: >70% of eligible participants (passed web-based and phone screener) will be consented, >70% of consented participants will pass further baseline screening procedures and will be randomized to treatment, >70% of participants who are randomized to treatment will be retained at follow-up. Reasons for ineligibility and drop out will also be assessed.
Measured: Anticipated study period of 12 months
Adherence, as measured by the percentage of assigned and completed intervention group practices.
Completion of at least 50% of assigned intervention group practices (Ecological Momentary Assessments for Mindful Awareness group; mindfulness practices for Mindful Activity group) is considered acceptable.
Measured: Baseline to follow-up, an anticipated 8 weeks
Secondary outcomes (1)
Change in depressive symptoms, as measured by the total score on the 9-item Patient Health Questionnaire (PHQ-9).
The 9-item Patient Health Questionnaire (PHQ-9) has a total score scale range of 0 to 27, with higher values indicating more depressive symptoms.
Measured: Baseline to post-intervention, an anticipated 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start3 Jun 2022
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either a Mindful Activity group or a Mindful Awareness group. Randomization will occur by chance (50%) at the end of the baseline visit.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Stefanie E Mayer, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255380
- Sponsor's protocol ID
- IRB# 21-35255
- Other IDs
- R00AG062778
- Acronym
- EMMA
- Status last verified
- May 2025
- First submitted
- 10 Feb 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial Examining the Effects of Daily Mindfulness in Woman With a History of Child Adversity
- ClinicalTrials.gov ID
- NCT05255380
- Acronym / sponsor ID
- EMMA / IRB# 21-35255
- Keywords
- Mindfulness, Adverse childhood experiences, Stress, Depressive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 24 Feb 2022 (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.
The aim of this pilot Randomized Controlled Trial (RCT) is to test whether brief mindfulness-based practices will improve well-being and health in women (age 30-50) with a history of early life adversity. Following a baseline visit (remotely via Zoom), participants are randomized (50% probability) to either a Mindful Activity group or a Mindful Awareness group. In the Mindful Activity group, participants will complete brief (approximately 5-10 min) audio-guided mindfulness practices twice a day (morning and evening) for 8 weeks using the study app. This is followed by a brief survey about their current thoughts and feelings. In the Mindful Awareness group, participants are asked to be mindful (pay attention) to their thoughts and feelings twice a day (morning and evening) for 8 weeks using the study app. After the 8-week intervention period, all participants complete a follow-up visit (remotely). Primary goals of the pilot RCT are to test acceptability, feasibility, and adherence.
Detailed description
The pilot Randomized Controlled Trial (RCT) randomly assigns midlife women (age 30-50) with a history of early life adversity to either a Mindful Activity group or a Mindful Awareness group to primarily test acceptability, feasibility, and adherence. Randomization will occur by chance at the end of the baseline visit.
Participants randomized to the Mindful Activity group will receive 8 weeks of ecological momentary assessment and intervention sessions via the study app. Mindfulness-based interventions consist of mindfulness and compassion-based practices. For example, practices focus on the breath/body (e.g., 3-minute breathing space; compassionate body scan; five senses mediation), on increasing participants' inner resources (e.g., imaging a safe person or safe place), on reducing negative affect (e.g., self-compassionate and acceptance-based practices), or on increasing positive emotions (e.g., gratitude practice; metta practices). All interventions are audio-guided and approximately 5-10 minutes. Participants complete two mindfulness interventions/day (one in the morning; one in the evening). After completing a mindfulness-based intervention, participants will complete ecological momentary assessments of their current psychological stress states (e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection) via the study app.
Participants randomized to the Mindful Awareness group are instructed to be mindful (pay attention) to their current thoughts and feelings and complete ecological momentary assessments of their current psychological stress states (e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection) twice/day (morning and evening) for 8 weeks via the study app.
A trained research assistant will monitor participant adherence and address potential difficulties. All participants will complete assessments at baseline (pre-intervention) and post-intervention (after the 8-week intervention). Weekly measures of depressive symptoms are also obtained. The investigators plan to consent about 100 participants with the goal of having 70 eligible participants enrolled in the study (about 35 in each group).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to either a Mindful Activity group or a Mindful Awareness group. Randomization will occur by chance (50%) at the end of the baseline visit.
| Arm | Type | Receives |
|---|---|---|
| Mindful Activity group | Experimental | Behavioral: Mindfulness and compassion-based practices; approximately 5-10 minutes two times/dayParticipants complete mindfulness and compassion-based practices via the study app. |
| Mindful Awareness group | Sham comparator | Behavioral: Mindful awareness and reporting of current thoughts and feelings, 2 times/dayParticipants monitor and report their thoughts and feelings via the study app. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female sex and gender identity (to control for sex and gender differences in stress responses and health outcomes)
- age 30-50 (to examine intervention effects on health outcomes in midlife)
- ≥2 Adverse Childhood Experiences (to ensure exposure to early life adversity)
- mild depressive symptoms (to allow for outcome improvements: PHQ-9 ≥ 5)
- having a smartphone (to access app-based assessments/interventions)
Key exclusion criteria (8 listed)
- Non-English speaker or unable to provide informed consent
- Current regular mindfulness practice (exclude if >20 min/week)
- Major psychiatric condition, including psychosis/schizophrenia, bipolar disorder, post-traumatic stress disorder, eating disorders, alcohol/substance use, major depression (PHQ-9 ≥ 15), and self-harm or suicidal ideation
- Major medical conditions, including no history of coronary heart disease, diabetes, severe asthma or lung disease, autoimmune disorders, infectious disease, epilepsy, brain injury, endocrine disorders, diagnosis of cancer or chemotherapy or radiation in the past 10 years
- Free from medications known to affect the immune and endocrine systems with the exception of antidepressant medication and oral contraceptives
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 |
|---|---|---|
| Mindfulness and compassion-based practices; approximately 5-10 minutes two times/dayThe app-based (audio-guided) interventions consist of mindfulness and compassion-based practices that are selected to maximize their effect on stress targets. Interventions include, for example, practices that focus on the breath/body (e.g., 3-minute breathing space; compassionate body scan; five senses mediation), on increasing participants' inner resources (e.g., imaging a safe person or safe place), on reducing negative affect (e.g., self-compassion and acceptance-based practices), or on increasing positive emotions (e.g., gratitude practice; metta practices). | Behavioural | Mindful Activity group |
| Mindful awareness and reporting of current thoughts and feelings, 2 times/dayParticipants are instructed to be mindful (pay attention) to their current thoughts and feelings and complete ecological momentary assessments of their current psychological stress states (e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection) | Behavioural | Mindful Awareness group |
Primary outcome
Acceptability of the intervention will be measured with an adapted version of the Treatment Acceptability Questionnaire (TAQ).
Time frame: Assessed at post-intervention, approximately 8 weeks from baseline
The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view their assigned intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable), with a possible score range from 6 to 42. Higher scores indicate better treatment acceptability and positive perceptions of the treatment. A total mean score of at least 24 will indicate sufficient acceptability of the intervention.
Feasibility, as indicated by numbers of participants screened (completed web-based screener and phone screener), eligible based on web-based screener and phone screener, consented, randomized to treatment, and retained at follow-up.
Time frame: Anticipated study period of 12 months
Feasibility outcomes will include: >70% of eligible participants (passed web-based and phone screener) will be consented, >70% of consented participants will pass further baseline screening procedures and will be randomized to treatment, >70% of participants who are randomized to treatment will be retained at follow-up. Reasons for ineligibility and drop out will also be assessed.
Adherence, as measured by the percentage of assigned and completed intervention group practices.
Time frame: Baseline to follow-up, an anticipated 8 weeks
Completion of at least 50% of assigned intervention group practices (Ecological Momentary Assessments for Mindful Awareness group; mindfulness practices for Mindful Activity group) is considered acceptable.
1 secondary outcome
Change in depressive symptoms, as measured by the total score on the 9-item Patient Health Questionnaire (PHQ-9).
Time frame: Baseline to post-intervention, an anticipated 8 weeks
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 4 May 2025.
- Individual participant dataSharing planned: No
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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.
Stefanie E Mayer, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day and Mindful awareness and reporting of current thoughts and feelings, 2 times/day in people with Stress and Psychological Stress, run by University of California, San Francisco at 1 site in United States.
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 8 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 4 May 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Acceptability of the intervention will be measured with an adapted version of the Treatment Acceptability Questionnaire (TAQ). (time frame: Assessed at post-intervention, approximately 8 weeks from baseline). 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 4 May 2025.