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Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

Primary Purpose

Depressive Symptoms, Anxious Symptoms

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Mindfulness-based Intervention

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Mindfulness, Well-being, Emotion Regulation, Perceived Stress, Self-Compassion

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

York University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness-based Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT03769233

First Posted

December 6, 2018

Last Updated

April 12, 2021

Sponsor

York University

1. Study Identification

Unique Protocol Identification Number

NCT03769233

Brief Title

Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 14, 2018 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Symptoms, Anxious Symptoms

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-based Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-based Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

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

Title

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

Description

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

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)

Title

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

Description

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

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)

Secondary Outcome Measure Information:

Title

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

Description

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

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)

Title

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

Description

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

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)

Title

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

Description

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

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)

Title

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

Description

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

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. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

29 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Jennine S Rawana, PhD,C.Psych.

Organizational Affiliation

York University

Official's Role

Principal Investigator

Facility Information:

Facility Name

York University

City

North York

State/Province

Ontario

ZIP/Postal Code

M3J 1P3

Country

Canada

12. IPD Sharing Statement

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Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms

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