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NCT05787483 · ClinicalTrials.gov registry record · NA

Biopsychosocial Outcomes of Mindfulness-based Instruction

A NA study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
NA
Development phase
68
Enrollment target

NCT05787483: Completed NA study, sponsored by University of Alabama at Birmingham.

NCT05787483 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 68 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05787483, a NA study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
NA
Development phase
68 participants
Enrollment target

Study Summary

Over 20% of adolescents living in the United States have a diagnosable psychiatric disorder. However, most adolescents who need mental health services do not receive them due to many reasons, including low resources in families and communities, stigma, lack of mental health providers, and other barriers to mental health care access. Alabama currently ranks 50th in access to mental healthcare and 51st (LAST) in mental healthcare provider availability with only one mental healthcare provider for every 920 persons in need. Most adolescents attend school, so delivering mental health services in the school setting eliminates many barriers to mental health care access. From the point of prevention, participation in universal social and emotional learning (SEL) programs within the school setting improves social and emotional skills, behaviors, attitudes, and academic performance. Mindfulness-based instruction is a promising approach to SEL for improving psychological functioning that is evidence-based, widely available, and scalable to various populations and settings. This project aims to investigate whether a SEL program that incorporates mindfulness-based instruction (MindUP) leads to improvements in not only self-reported well-being (i.e., anxiety, mindful attention, perceived stress, and positive and negative affect), but also objectively measured executive functioning, academic achievement, and regulation of stress physiology. The investigators will partner with schools that serve historically underserved students to test the effectiveness of the MindUP program in 5th and 6th graders. This study has the potential to benefit underserved students and their teachers who will receive training on sustainable implementation of the MindUP curriculum.

Primary Outcome

Autonomic reactions subscale of Children's Test Anxiety Scale (CTAS): has 9-items that ask the students to respond in terms of how they think, feel, or act during a test. All the questions start with the same stem, ''While I am taking tests…'' (e.g., "I feel nervous"; "My head hurts"). Students are asked to choose between four response options (i.e., almost never, 1; some of the time, 2; most of the time, 3; almost always, 4).

Interventions

  • BEHAVIORAL MindUP group
  • BEHAVIORAL active control group

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2023-08-14
Est. Completion 2024-10-16
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT05787483 record still lists

NCT05787483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which MindUP group is the first listed.

NCT05787483 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05787483 about?

NCT05787483 is a clinical study titled "Biopsychosocial Outcomes of Mindfulness-based Instruction". Over 20% of adolescents living in the United States have a diagnosable psychiatric disorder. However, most adolescents who need mental health services do not receive them due to many reasons, including low resources in families and communities, stigma, lack of mental health providers, and other barr...

What is the current status of trial NCT05787483?

This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2023-08-14. Estimated completion is 2024-10-16.

What interventions are being tested in trial NCT05787483?

The interventions under investigation include: MindUP group (BEHAVIORAL), active control group (BEHAVIORAL).

Who is sponsoring clinical trial NCT05787483?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05787483's enrollment target sits among peer trials

68 1133rd of 2000 higher than 862 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05787483, the US trial registry maintained by the National Library of Medicine. NCT05787483 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.