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Virtual Mindfulness Intervention RCT

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-Based Intervention
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Mindfulness, MBI, Depression, Anxiety disorders, Virtual, Short-term

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ≥18 years of age
  • are referred to the mindfulness group by a physician

Exclusion Criteria:

  • have previously completed a full (≥8-week) MBI in the past 3 years
  • meet criteria for substance abuse, psychosis, and/or mania
  • express active suicidality.

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness-based intervention

Waitlist

Arm Description

Participants will take part in an adapted and abbreviated version of the traditional eight-week MBCT protocol, conducted virtually via Zoom. Participants will meet for five, weekly, two-hour sessions. The group size will be larger than traditional MBCT groups (i.e. 16-20 participants rather than 12 participants).

Participants will be placed in a group with no treatment interventions for the duration of five weeks. Once these five weeks are complete, these participants will be placed in the next mindfulness clinic session to receive treatment. This does not the typical wait-list time for clinical services, which currently exceeds eight weeks

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder - 7 (GAD-7)
). The GAD-7 is a 7-item self-report measure that assesses the presence of generalized anxiety symptoms within the past two weeks. Response options range from 0 (Not at All) to 3 (Nearly every day).
Depression, Anxiety, Stress Scale-21 (DASS-21)
The DASS-21 is a 21-item measure used to assess depression, anxiety, and stress symptoms. The DASS-21 is a shortened version of the original DASS, which was 42 items in length.
Patient Health Questionnaire - 9 (PHQ-9)
The PHQ-9 is a 9-item measure for assessing depression severity.

Secondary Outcome Measures

Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a 10-item measure that assesses perceived stress within the last month. It is frequently used as a measure of acute distress, thus this measure is expected to be inversely related to positive well-being.
Warwick Edinburgh Mental Well- Being Scale (WEMWBS)
The Warwick Edinburgh Mental Well- Being Scale (WEMWBS) is a 14-item measure that assesses positive well-being within the last two weeks.
Self-Compassion Scale
The Self-Compassion Scale is a 24-item scale that assesses an individual's level of self-compassion.
Five Facet Mindfulness Questionnaire (FFMQ)
The FFMQ is a 39-item questionnaire that assesses an individual's self-perceived use of mindfulness in their daily life.
Maslach Burnout Inventory (MBI)
The MBI is a 22-item questionnaire that assesses the frequency and intensity of perceived burnout.

Full Information

First Posted
July 15, 2021
Last Updated
May 9, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05374213
Brief Title
Virtual Mindfulness Intervention RCT
Official Title
Effects of a Virtual Mindfulness-based Intervention for Depression and Anxiety in a Community Psychiatric Sample
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
October 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mindfulness-based interventions (MBIs) have emerged as clinically effective interventions for anxiety, depression, and general distress. However, there are significant barriers to accessing MBIs in the general population including length of treatment and cost. Furthermore, in the present COVID-19 pandemic, there is a demand to conduct virtual clinical services. However, to date, not much is known regarding the effectiveness of mindfulness groups that are conducted virtually. The aim of the present study is to examine the effectiveness of a five-week abbreviated MBCT intervention delivered virtually for a physician-referred, treatment-seeking, community sample. The virtual mindfulness group will be compared to a five-week wait-list control group. All wait-listed study participants will be given the opportunity to participate in the intervention after study completion. At present, clinical wait times for services far exceed five weeks, thus participants that are wait-listed will not experience delay in their treatment.
Detailed Description
Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately, patients often face barriers to accessing mental health care, particularly psychotherapeutic interventions, including long wait-times and demanding therapeutic protocols. For instance, standardized MBIs such as mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) are typically eight weeks in length. MBSR and MBCT, traditional MBTs, can demand over 30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care. Furthermore, many clients are unable to access in-person interventions. At present the Sunnybrook Mindfulness Clinic is not conducting any virtual services due to the unknown benefit of virtual mindfulness interventions, creating significant barriers to clinical care for patients. The goal of this project is to compare the effectiveness of virtually delivered, abbreviated MBI (<10 hours of clinical time and <10 hours of homework) to a wait-list control condition in terms of reducing symptoms of depression/anxiety/stress and improving wellbeing. If effective, this abbreviated MBI conducted virtually could enable clients to pursue virtual services during the current COVID-19 pandemic. MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with western psychological advances to improve stress-management and self-care. Participants learn to generate less distress, engage more positively and fully in their lives and experiences, and respond more adaptively to challenges instead of reacting in automatic and unhelpful ways. Participants in MBI often describe the intervention as transformative. The abbreviated MBI protocol has been piloted in an uncontrolled study and indicated significant benefit for patients in terms of symptom improvement. However, this will be the first time that the investigators pilot a virtual adaptation to the mindfulness group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Mindfulness, MBI, Depression, Anxiety disorders, Virtual, Short-term

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The experimental design is a RCT with two conditions: 1) treatment condition and 2) wait-list control condition. Outcome measures will focus on self-reported ratings of (primary) depression, anxiety, and stress and (secondary) well-being measures.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based intervention
Arm Type
Experimental
Arm Description
Participants will take part in an adapted and abbreviated version of the traditional eight-week MBCT protocol, conducted virtually via Zoom. Participants will meet for five, weekly, two-hour sessions. The group size will be larger than traditional MBCT groups (i.e. 16-20 participants rather than 12 participants).
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants will be placed in a group with no treatment interventions for the duration of five weeks. Once these five weeks are complete, these participants will be placed in the next mindfulness clinic session to receive treatment. This does not the typical wait-list time for clinical services, which currently exceeds eight weeks
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Intervention
Intervention Description
Mindfulness practices use a non-stigmatizing approach, combining secularized eastern meditative practices with western psychological advances to improve stress-management and self-care. Participants learn to generate less distress, engage more positively and fully in their lives and experiences, and respond more adaptively to challenges instead of reacting in automatic and unhelpful ways.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder - 7 (GAD-7)
Description
). The GAD-7 is a 7-item self-report measure that assesses the presence of generalized anxiety symptoms within the past two weeks. Response options range from 0 (Not at All) to 3 (Nearly every day).
Time Frame
At three time points (weeks 0,3, and 5) over 5 week intervention period.
Title
Depression, Anxiety, Stress Scale-21 (DASS-21)
Description
The DASS-21 is a 21-item measure used to assess depression, anxiety, and stress symptoms. The DASS-21 is a shortened version of the original DASS, which was 42 items in length.
Time Frame
At three time points (weeks 0,3, and 5) over 5 week intervention period.
Title
Patient Health Questionnaire - 9 (PHQ-9)
Description
The PHQ-9 is a 9-item measure for assessing depression severity.
Time Frame
At three time points (weeks 0,3, and 5) over 5 week intervention period.
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)
Description
The Perceived Stress Scale (PSS) is a 10-item measure that assesses perceived stress within the last month. It is frequently used as a measure of acute distress, thus this measure is expected to be inversely related to positive well-being.
Time Frame
At three time points (weeks 0,3, and 5) over 5 week intervention period.
Title
Warwick Edinburgh Mental Well- Being Scale (WEMWBS)
Description
The Warwick Edinburgh Mental Well- Being Scale (WEMWBS) is a 14-item measure that assesses positive well-being within the last two weeks.
Time Frame
At three time points (weeks 0,3, and 5) over 5 week intervention period.
Title
Self-Compassion Scale
Description
The Self-Compassion Scale is a 24-item scale that assesses an individual's level of self-compassion.
Time Frame
At three time points (weeks 0,3, and 5) over 5 week intervention period.
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
The FFMQ is a 39-item questionnaire that assesses an individual's self-perceived use of mindfulness in their daily life.
Time Frame
At three time points (weeks 0,3, and 5) over 5 week intervention period.
Title
Maslach Burnout Inventory (MBI)
Description
The MBI is a 22-item questionnaire that assesses the frequency and intensity of perceived burnout.
Time Frame
At three time points (weeks 0,3, and 5) over 5 week intervention period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥18 years of age are referred to the mindfulness group by a physician Exclusion Criteria: have previously completed a full (≥8-week) MBI in the past 3 years meet criteria for substance abuse, psychosis, and/or mania express active suicidality.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil A Rector, PhD
Phone
416-480-6100
Ext
2233
Email
neil.rector@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmine Gish, BSc
Phone
416-480-6100
Ext
7958
Email
jasmine.gish@sri.utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil A Rector, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil A Rector, Phd
Phone
416-480-6100
Ext
2233
Email
neil.rector@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Jasmine Gish, BSc
Phone
416-480-6100
Ext
7958
Email
jasmine.gish@sri.utoronto.ca

12. IPD Sharing Statement

Learn more about this trial

Virtual Mindfulness Intervention RCT

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