Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day for Stress

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CAStress+4 MoreMindfulness and compassion-based practices; approximately 5-10 minutes two times/day - Behavioral
Eligibility
30 - 50
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether brief mindfulness-based practices can help improve wellbeing and health for women who have faced early life adversity. There are two groups in the trial, one that will do mindful activities and one that will do mindful awareness, both for 8 weeks. The trial is measuring feasibility and acceptability.

Eligible Conditions
  • Child Abuse
  • Stress
  • Symptoms
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Youth Mindful Awareness Program (YMAP)
1
Mindfulness program
1
Mindfulness-based Intervention

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: Anticipated study period of 12 months

Month 12
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.
Week 8
Acceptability of the intervention will be measured with an adapted version of the Treatment Acceptability Questionnaire (TAQ).
Week 8
Adherence, as measured by the percentage of assigned and completed intervention group practices.
Week 8
Change in depressive symptoms, as measured by the total score on the 9-item Patient Health Questionnaire (PHQ-9).

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Youth Mindful Awareness Program (YMAP)
1
Mindfulness program
1
Mindfulness-based Intervention

Trial Design

2 Treatment Groups

Mindful Activity group
1 of 2
Mindful Awareness group
1 of 2

Experimental Treatment

Non-Treatment Group

70 Total Participants · 2 Treatment Groups

Primary Treatment: Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day · Has Placebo Group · N/A

Mindful Activity group
Behavioral
Experimental Group · 1 Intervention: Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day · Intervention Types: Behavioral
Mindful Awareness group
Behavioral
ShamComparator Group · 1 Intervention: Mindful awareness and reporting of current thoughts and feelings, 2 times/day · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: anticipated study period of 12 months

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,450 Previous Clinical Trials
4,279,507 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,312 Previous Clinical Trials
11,758,268 Total Patients Enrolled
Stefanie E Mayer, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
53 Total Patients Enrolled

Eligibility Criteria

Age 30 - 50 · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You may be experiencing some mild symptoms of depression (score of 5 or higher on a depression assessment test).
You must have a smartphone to participate in the study, as some assessments and treatments will be accessed through a mobile app.
The study will include only females to study how stress affects their health outcomes compared to males.
You have experienced at least two traumatic events during your childhood.

Who else is applying?

What state do they live in?
California83.3%
Michigan16.7%
How old are they?
18 - 65100.0%
What site did they apply to?
University of California, San Francisco100.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. University of California, San Francisco: < 24 hours
Typically responds via
Email100.0%
References

Frequently Asked Questions

Does this clinical trial currently have capacity to enroll individuals?

"According to clinicaltrials.gov, this medical experiment is still seeking volunteers; it was initially posted on June 3rd 2022 and its most recent update was November 17th of the same year." - Anonymous Online Contributor

Unverified Answer

How can I become involved in this experimental research?

"This study desires 70 participants aged 30-50 who experience stress and psychological distress. Furthermore, these patients should identify as female, have endured at least two Adverse Childhood Experiences, display mild depressive symptoms (PHQ-9 ≥ 5), and possess a smartphone in order to leverage app-based interventions." - Anonymous Online Contributor

Unverified Answer

Does this study offer participation for individuals younger than 65 years old?

"According to the eligibility requirements, this trial has a minimum age of 30 years old and will not accept any participants older than 50." - Anonymous Online Contributor

Unverified Answer

What is the aggregate amount of individuals subscribing to this trial?

"Correct. Information from clinicaltrials.gov demonstrates that the current recruitment for this medical trial is still underway - it was initially posted on June 3rd 2022 and recently updated on November 17th of the same year. 70 participants need to be gathered at a single site in order to complete enrollment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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