Virtual Mindfulness Intervention RCT

Depression Clinical Trial

Official title:

Effects of a Virtual Mindfulness-based Intervention for Depression and Anxiety in a Community Psychiatric Sample

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374213
• Other study ID #: 3181
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 20, 2022

Study information

• Verified date: May 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: Neil A Rector, PhD
• Phone: 416-480-6100
• Email: neil.rector[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Mindfulness-Based Intervention
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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At three time points (weeks 0,3, and 5) over 5 week intervention period.
Primary	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.	At three time points (weeks 0,3, and 5) over 5 week intervention period.
Primary	Patient Health Questionnaire - 9 (PHQ-9)	The PHQ-9 is a 9-item measure for assessing depression severity.	At three time points (weeks 0,3, and 5) over 5 week intervention period.
Secondary	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.	At three time points (weeks 0,3, and 5) over 5 week intervention period.
Secondary	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.	At three time points (weeks 0,3, and 5) over 5 week intervention period.
Secondary	Self-Compassion Scale	The Self-Compassion Scale is a 24-item scale that assesses an individual's level of self-compassion.	At three time points (weeks 0,3, and 5) over 5 week intervention period.
Secondary	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.	At three time points (weeks 0,3, and 5) over 5 week intervention period.
Secondary	Maslach Burnout Inventory (MBI)	The MBI is a 22-item questionnaire that assesses the frequency and intensity of perceived burnout.	At three time points (weeks 0,3, and 5) over 5 week intervention period.