tailored MBI (.b) for Stress, Emotional

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas Health Science Center at Houston, Houston, TXStress, Emotionaltailored MBI (.b) - Behavioral
Eligibility
18 - 25
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions
  • Stress, Emotional

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 7 Secondary · Reporting Duration: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention

Month 6
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)
Change in Distress as measured by Kessler Psychological Distress Scale (K10)
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)
Change in Risk Seeking as measured by Balloon Analogue Risk Task (BART)
Change in Self-Compassion as measured by Self-Compassion Scale (SCS)
Change in Social Connectedness as measured Social Connectedness Scale
Change in Stress as measured by Perceived Stress Scale (PSS)
Change in Vulnerability as measured by Psychological Vulnerability Scale

Trial Safety

Safety Progress

1 of 3

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Trial Design

2 Treatment Groups

attention control condition
1 of 2
tailored MBI (.b)
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: tailored MBI (.b) · No Placebo Group · Phase 1

tailored MBI (.b)
Behavioral
Experimental Group · 1 Intervention: tailored MBI (.b) · Intervention Types: Behavioral
attention control condition
Behavioral
ActiveComparator Group · 1 Intervention: attention control condition · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
818 Previous Clinical Trials
259,288 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
787 Previous Clinical Trials
657,382 Total Patients Enrolled
1 Trials studying Stress, Emotional
240 Patients Enrolled for Stress, Emotional
Diane M Santa Maria, DrPH,MSN,RN,PHNA-BC,FSAHM,FAANPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Eligibility Criteria

Age 18 - 25 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a young person who is homeless and receiving services at a specific location in Houston, Texas.
You must be able to speak English.
You can commit to being part of the study for its entire duration without having to move or relocate.
You are currently offering health or social services to young adults who are homeless.
You want to participate in an interview or be part of the Expert Advisory Panel.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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

"This research project seeks participants aged 18 to 25." - Anonymous Online Contributor

Unverified Answer

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 –" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - 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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