Virtual Mindfulness Intervention RCT

NCT05374213 | Completed

• 1 other identifier: 3181
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

Mindfulness; MBI; Depression; Anxiety disorders; Virtual; Short-term

Outcome Measures

Primary Outcomes (3)

• 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 previous two weeks. Measure will be used to assess change in presence of generalized anxiety symptoms at baseline, mid-treatment, and post-treatment. Response options for the 7-item scale range from 0 (Not at All) to 3 (Nearly every day), and scale scores range can from 0 to 21.

  At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.

• Depression, Anxiety, Stress Scale-21 (DASS-21)

  The DASS-21 is a 21-item measure used to assess depression, anxiety, and stress symptoms. Measure will be used to assess change in presence of depression, stress, and anxiety symptoms at baseline, mid-treatment, and post-treatment. The DASS-21 is a shortened version of the original DASS, which was 42 items in length.

  At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.

• Patient Health Questionnaire - 9 (PHQ-9)

  The PHQ-9 is a 9-item measure for assessing depression severity. Measure will be used to assess change in depressive severity at baseline, mid-treatment, and post treatment. PHQ-9 scores can range from 0 to 27, as each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)

  At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.

Secondary Outcomes (5)

• Perceived Stress Scale (PSS)

  At three time points (weeks 0,3, and 5) over 5 week intervention period.

• Warwick Edinburgh Mental Well- Being Scale (WEMWBS)

  At three time points (weeks 0,3, and 5) over 5 week intervention period.

• Self-Compassion Scale

  At three time points (weeks 0,3, and 5) over 5 week intervention period.

• Five Facet Mindfulness Questionnaire (FFMQ)

  At three time points (weeks 0,3, and 5) over 5 week intervention period.

• Maslach Burnout Inventory (MBI)

  At three time points (weeks 0,3, and 5) over 5 week intervention period.

Study Arms (2)

Mindfulness-based intervention

EXPERIMENTAL

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).

Behavioral: Mindfulness-Based Intervention

Waitlist

NO INTERVENTION

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

Interventions

Mindfulness-Based Intervention BEHAVIORAL

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.

Mindfulness-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Joseph Brant Hospital: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Neil A Rector, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: May 16, 2022
• Study Start: October 1, 2021
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: December 10, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)