Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769233
• Other study ID #: E2018-349
• Status: Completed
• Phase: N/A
• Start date: December 14, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2021
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxious Symptoms
• Depression
• Depressive Symptoms

Intervention

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.

Locations

Country	Name	City	State
Canada	York University	North York	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)