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Mindfulness-Based Intervention

Mindfulness-Based Intervention for Stress

Phase 1
Waitlist Available
Led By Diane M Santa Maria, DrPH,MSN,RN,PHNA-BC,FSAHM,FAAN
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Youth Participants: English speaking
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Awards & highlights

Study Summary

This trial will test a Mindfulness-Based Intervention (MBI) called ".b" to see if it is helpful for stress management, emotional regulation, and impulsivity in Youth Experiencing Homelessness (YEH).

Who is the study for?
This trial is for English-speaking youth experiencing homelessness in the Houston, Texas area who are receiving services at certain sites. Participants must be able to commit to the full study period and show interest in being interviewed or joining an Expert Advisory Panel.Check my eligibility
What is being tested?
The study tests a tailored Mindfulness-Based Intervention (.b) designed specifically for homeless youth, comparing it with an attention control condition. The focus is on assessing how feasible and acceptable this intervention is before conducting a larger trial on its effectiveness.See study design
What are the potential side effects?
Since this trial involves mindfulness practices rather than medical treatments, traditional side effects are not expected. However, participants may experience emotional discomfort or distress when engaging with their thoughts and feelings during mindfulness exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a young person who speaks English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Emotion Regulation as measured by Difficulties in Emotion Regulation Scale (DERS)
Change in Mindfulness as measured by Child and Adolescent Mindfulness Measure (CAMM)
Change in Mindfulness as measured by Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
+2 more
Secondary outcome measures
Change in Affect as measured by Positive and Negative Affect Scale (PANAS-SF)
Change in Anxiety as measured by Spielberger State-Trait Anxiety Inventory
Change in Depression as measured by Short Mood and Feelings Questionnaire (SMFQ)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: tailored MBI (.b)Experimental Treatment1 Intervention
Group II: attention control conditionActive Control1 Intervention

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,843 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,907 Total Patients Enrolled
Diane M Santa Maria, DrPH,MSN,RN,PHNA-BC,FSAHM,FAANPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this clinical research study?

"Eligible participants should be between 18 and 25 years old, with stress-related psychological issues. This trial is looking to recruit about 60 individuals in total."

Answered by AI

Is it possible to enroll in this experiment if one is of a certain age?

"This research project seeks participants aged 18 to 25."

Answered by AI

What is the major goal of this empirical research?

"The primary endpoint assessed in this trial over a period of baseline, post-intervention (1 day later), 3 months after treatment, and 6 months post-treatment is an alteration in self-compassion as measured with the Self Compassion Scale. Secondary objectives include observing modifications in distress through the Kessler Psychological Distress scale from 10 to 50 points - higher scores indicating worse outcomes - vulnerability via the Psychological Vulnerability Scale from 1 to 5 points - greater numbers implying more susceptibility - and social connectedness by means of Social Connectedness Scale across 20 items on a range between strongly disagreeing at 1 point up to strongly agreeing at 6 points –"

Answered by AI

What is the count of participants invited to join this experiment?

"Affirmative. Clinicaltrials.gov presents data that this medical research, which commenced on April 11th 2022, is currently recruiting participants. The study aims to enrol 60 people from a single site."

Answered by AI

Are there any opportunities for participants to join this medical study?

"Affirmative, a perusal of clinicaltrials.gov reveals that this trial is actively searching for study participants. The experiment was initially posted on April 11th 2022 and has since been revised as recently as August 29th 2022 - when 60 patients were targeted from one site."

Answered by AI

What possible risks may come with individualized MBI (.b) treatments?

"Limited evidence suggesting efficacy and safety has led the Power team to rate tailored MBI (.b)’s security as a 1 on this scale."

Answered by AI
~30 spots leftby Apr 2025