Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

A 5-week Mindfulness Program 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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Anxious Symptoms
• Intervention / Treatment: Behavioral: Mindfulness-based Intervention

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • North York, Ontario, Canada, M3J 1P3
      • York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Depressive Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks	Patient Health Questionnaire-9 (PHQ-9): Scale used to measure Depressive Symptoms, with higher scores reflecting greater levels of depressive symptoms	Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5
Change from Baseline Anxious Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks	Generalized Anxiety Disorder-7 (GAD-7): Scale used to measure Anxious Symptoms, with higher scores reflecting greater levels of anxious symptoms	Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Mental Wellbeing at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks	Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Scale used to measure Mental Wellbeing, with higher scores reflecting greater levels of mental wellbeing	Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Perceived Stress at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5	10-item Perceived Stress Scale (PSS-10): Scale used to measure Perceived Stress, with higher scores reflecting greater levels of perceived stress	Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Emotion Regulation Strategies at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5	Emotion Regulation Questionnaire (ERQ): Scale used to measure Emotion Regulation, with higher scores reflecting greater levels of emotion regulation strategies	Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Self-Compassion at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5	Self-Compassion Scale - Short Form (SCS-SF): Scale used to measure self-compassion, with higher scores reflecting greater levels of self-compassion	Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
Change from Baseline Mindful Awareness at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5	Five-Facet Mindfulness Questionnaires (FFMQ): Scale used to measure mindful awareness, with higher scores reflecting greater levels of mindfulness facets	Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)

Collaborators and Investigators

• Sponsor: York University
• Investigators: Principal Investigator: Dr. Jennine S Rawana, PhD,C.Psych., York University

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Mindfulness; Emotion Regulation; Well-being; Self-Compassion; Perceived Stress
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: E2018-349

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No