DepressionNCT05374213
Virtual Mindfulness Intervention RCT
A study testing Mindfulness-Based Intervention in people with Depression and Anxiety, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- are referred to the mindfulness group by a physician
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Virtual Mindfulness-based Intervention for Depression and Anxiety in a Community Psychiatric Sample
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Mindfulness-Based Intervention
- Keywords
- Mindfulness, MBI, Depression, Anxiety disorders, Virtual, Short-term
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
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.
Measured: At three time points (weeks 0,3, and 5) over 5 week intervention period.
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.
Measured: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Self-Compassion Scale
The Self-Compassion Scale is a 24-item scale that assesses an individual's level of self-compassion.
Measured: At three time points (weeks 0,3, and 5) over 5 week intervention period.
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.
Measured: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Maslach Burnout Inventory (MBI)
The MBI is a 22-item questionnaire that assesses the frequency and intensity of perceived burnout.
Measured: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Oct 2021
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Joseph Brant Hospital
- Responsible party
- Principal investigator, Dr. Neil Rector, Sunnybrook Health Sciences Centre
- Investigators
- Neil A Rector, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374213
- Sponsor's protocol ID
- 3181
- Status last verified
- May 2022
- First submitted
- 15 Jul 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Virtual Mindfulness-based Intervention for Depression and Anxiety in a Community Psychiatric Sample
- ClinicalTrials.gov ID
- NCT05374213
- Acronym / sponsor ID
- 3181
- Conditions
- Depression, Anxiety
- Keywords
- Mindfulness, MBI, Depression, Anxiety disorders, Virtual, Short-term
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Joseph Brant Hospital
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Mindfulness-Based InterventionParticipants 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). |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years of age
- are referred to the mindfulness group by a physician
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based InterventionMindfulness 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. | Behavioural | Mindfulness-based intervention |
Primary outcome
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
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.
Depression, Anxiety, Stress Scale-21 (DASS-21)
Time frame: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
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.
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.
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)
5 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Warwick Edinburgh Mental Well- Being Scale (WEMWBS)
Time frame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Self-Compassion Scale
Time frame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Maslach Burnout Inventory (MBI)
Time frame: At three time points (weeks 0,3, and 5) over 5 week intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil A Rector, PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention in people with Depression and Anxiety, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder - 7 (GAD-7) (time frame: At Baseline (week 0), Mid-treatment (week 3) and post-treatment (week 5) over five week intervention period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.