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OpenTrials
Completed

NCT Number: NCT01650233

Improving Wellness for Young Men

This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.

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Key information

Conditions

Stress-exposed Urban Male Youth

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

St. Ignatius Loyola Academy

Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year.
  • Parent/guardian consents
  • Student assents

Exclusion criteria

(as assessed by school staff):

  • significant psychopathology
  • significant developmental delay
  • significant substance abuse with behavioral consequences
  • significant behavioral problems
  • foster care due to consent restrictions)

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

Primary outcomes

  1. psychological symptoms

    Time frame: 6 months

    Psychological symptoms assessed include anxiety, hostility, and depression.

  2. coping

    Time frame: 6 months

    Coping assessed includes rumination and typically positive and negative coping approaches.

Secondary outcomes

  1. Sleep

    Time frame: 6 months

    Sleep was measured using diary and actigraphy.

  2. stress

    Time frame: 6 months

    Stress was measured using self-report and salivary cortisol.

Other outcomes

  1. Behavior

    Time frame: 6 months

    Assessed by teacher-rated behavior ratings.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 26, 2012
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.