Clinical trial NCT05374213: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Mindfulness
MBI
Depression
Anxiety disorders
Virtual
Short-term
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Joseph Brant Hospital
First posted: 2022-05-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
measure: Depression, Anxiety, Stress Scale-21 (DASS-21)
timeFrame: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
measure: Warwick Edinburgh Mental Well- Being Scale (WEMWBS)
timeFrame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
measure: Self-Compassion Scale
timeFrame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
measure: Maslach Burnout Inventory (MBI)
timeFrame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Neil A Rector, PhD
role: PRINCIPAL_INVESTIGATOR
References: