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Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

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ClinicalTrials.gov Identifier: NCT03769233
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Jennine Rawana, York University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Anxious Symptoms Behavioral: Mindfulness-based Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 5-week Mindfulness Program for Emerging Adults Experiencing Anxious and/or Depressive Symptoms
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Mindfulness-based Intervention
5 week, manual-based group MBI treatment for depressive and anxious symptoms
Behavioral: Mindfulness-based Intervention
MBI will be delivered in group format, 90 minutes per week, for 5 consecutive weeks with 6-15 participants per group.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769233


Contacts
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Contact: Benjamin D Diplock, BSc 416-736-2100 ext 20771 bdiplock@yorku.ca

Locations
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Canada, Ontario
York University Recruiting
North York, Ontario, Canada, M3J 1P3
Contact: Benjamin D Diplock, BSc    416-736-2100 ext 20771    bdiplock@yorku.ca   
Sponsors and Collaborators
York University
Investigators
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Principal Investigator: Dr. Jennine S Rawana, PhD,C.Psych. York University

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Responsible Party: Dr. Jennine Rawana, Associate Professor & Clinical Developmental Psychologist, York University
ClinicalTrials.gov Identifier: NCT03769233     History of Changes
Other Study ID Numbers: E2018-349
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Jennine Rawana, York University:
Mindfulness
Well-being
Emotion Regulation
Perceived Stress
Self-Compassion

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms