Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

NCT03769233 | Completed

• 1 other identifier: E2018-349
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxious Symptoms

Keywords

Mindfulness; Well-being; Emotion Regulation; Perceived Stress; Self-Compassion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

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

  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

  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

  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

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

Study Arms (1)

Mindfulness-based Intervention

EXPERIMENTAL

5 week, manual-based group MBI treatment for depressive and anxious symptoms

Behavioral: Mindfulness-based Intervention

Interventions

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.

Mindfulness-based Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• York University: lead

Study Sites (1)

York University

North York, Ontario, M3J 1P3, Canada

Location

MeSH Terms

Conditions

Depression; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Dr. Jennine S Rawana, PhD,C.Psych.

  York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Clinical Developmental Psychologist

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: December 14, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

CA (1)