Depression Clinical Trial
Official title:
Effects of a Virtual Mindfulness-based Intervention for Depression and Anxiety in a Community Psychiatric Sample
NCT number | NCT05374213 |
Other study ID # | 3181 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2021 |
Est. completion date | October 20, 2022 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
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. |
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