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Completed

NCT Number: NCT03769233

Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

Emerging adults (EA; 18 to 29 years old) in Canada are among the age group with highest risk of developing mental health issues. Despite this, they experience especially long wait-times for mental health services. To date, there has been minimal research into developmentally appropriate treatment options for the EA population. Mindfulness-based interventions (MBIs) are emerging as a potential treatment to address this need. MBIs are group-based psychological treatments for coping with distress, with the goal of improving mental health. Unfortunately, these 'traditional' MBIs are very demanding in terms of time and homework and are therefore not sufficiently feasible for the demanding schedules of EA university students. Instead, recent studies suggest a role for briefer MBIs in addressing mental health symptom burden, well-being and reducing acute stress symptoms. The brevity of these interventions make them theoretically better suited for EA university populations. High quality research, including controlled clinical trials are needed to demonstrate whether MBIs can provide efficacious treatment to improve the lives of EA university students. The current study will test the efficacy of a five-week MBI baseline within-subject controlled trial.

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Key information

Conditions

Depressive Symptoms Anxious Symptoms Behavior Behavioral Symptoms Depression Emotional Regulation Self-Control Social Behavior

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York University

North York, Ontario, M3J 1P3, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • consenting Emerging Adults
  • Ability to communicate, in written and spoken English

Exclusion criteria

  • Minimal depressive and anxious symptoms (score below 10 and 8 on the PHQ-9/GAD-7
  • Current substance abuse or dependence, psychosis or mania
  • Current self-injurious behavior of past suicide attempt
  • Previously completed >4 weeks of an MBI, or general Cognitive behavioral Therapy, in the past 3 years

Treatment and study plan

Mindfulness-based Intervention

Behavioral

MBI will be delivered in group format, 90 minutes per week, for 5 consecutive weeks with 6-15 participants per group.

Primary outcomes

  1. Change from Baseline Depressive Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks

    Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5

    Patient Health Questionnaire-9 (PHQ-9): Scale used to measure Depressive Symptoms, with higher scores reflecting greater levels of depressive symptoms

  2. Change from Baseline Anxious Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks

    Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)

    Generalized Anxiety Disorder-7 (GAD-7): Scale used to measure Anxious Symptoms, with higher scores reflecting greater levels of anxious symptoms

  3. Change from Baseline Mental Wellbeing at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks

    Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)

    Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Scale used to measure Mental Wellbeing, with higher scores reflecting greater levels of mental wellbeing

Secondary outcomes

  1. Change from Baseline Perceived Stress at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5

    Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)

    10-item Perceived Stress Scale (PSS-10): Scale used to measure Perceived Stress, with higher scores reflecting greater levels of perceived stress

  2. Change from Baseline Emotion Regulation Strategies at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5

    Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)

    Emotion Regulation Questionnaire (ERQ): Scale used to measure Emotion Regulation, with higher scores reflecting greater levels of emotion regulation strategies

  3. Change from Baseline Self-Compassion at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5

    Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)

    Self-Compassion Scale - Short Form (SCS-SF): Scale used to measure self-compassion, with higher scores reflecting greater levels of self-compassion

  4. Change from Baseline Mindful Awareness at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5

    Time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)

    Five-Facet Mindfulness Questionnaires (FFMQ): Scale used to measure mindful awareness, with higher scores reflecting greater levels of mindfulness facets

Sponsors and collaborators

Lead sponsor

York University

Other

Registry information

Official study title

A 5-week Mindfulness Program for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2018
Registry last updated
Apr 13, 2021

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.

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