An interventional study of Emotion-focused mindfulness group in Depression and Anxiety, sponsored by University of Toronto Practice Based Research Network. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-20.
Sponsored by University of Toronto Practice Based Research Network · Not applicable, Interventional, and Treatment
Living with symptoms of mental illness is associated with psychosocial impairment as it can affect someone's ability to work, their relationships and level of functioning. This also has high economic costs on a societal level. It has been shown that an increase in self-compassion may result in a secondary benefit of reducing psychological distress, which could offer substantial benefits. There is little empirical data on Emotion Focused Mindfulness (EFM) interventions for the population we are studying. This study aims to address this gap in the literature and practice, thus advancing the field.
Study Design
The proposed study is a non-controlled, open-label, repeated measures intervention study. It is a two year feasibility study.
Procedure:
Recruitment
Participants will be recruited through the Mount Sinai Academic Family Health Team. Patients who experience symptoms of depression and/or anxiety, may be referred by any member of the family health team, self-referrals through the family health team will also be accepted. Patients will be screened for eligibility for the EFM Group by the group facilitators. Patients may participate in the EFM group and refuse to participate in the research study.
When patients agree to participate in the group intervention, patients will then be asked about interest in participating in this research. Group facilitators will provide details about the study. Interested patients are given the consent form to review. The group facilitator leaves the room and the research associate will then come into the room to obtain written consent.
Intervention
The group will run for 8-weeks. Each group session is 2 and a half hours. Half way through the intervention there will be a 5 hour retreat on the weekend. A typical group format includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. Then group members will have time to report on recollections from meditation and facilitators will provide feedback. There is a break and the second part of the group focuses on a didactic teaching topic. Topics change each week. EFM groups will run between September 2016 and June 2018.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Toronto Practice Based Research Network is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Must be patient of Mount Sinai Academic Family Health Team
Exclusion Criteria: (each based on assessment by group facilitators)
8-week mindfulness group
Behavioral: Emotion-focused mindfulness group
Intervention The group will run for 8-weeks. Each group session is 2 and a half hours. Half way through the intervention there will be a 5 hour retreat on the weekend. A typical group format includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. Then group members will have time to report on recollections from meditation and facilitators will provide feedback. There is a break and the second part of the group focuses on a didactic teaching topic. Topics change each week; groups will run between October 2016 and June 2018.
Self-Compassion Scale (SCS) to assess change between baseline, midpoint, group completion and 2 months post group.
26 question self-administered questionnaire
Time frame: Weeks 1, 4, 8 and 2 months post group completion
Positive and Negative Affect Scale (PANAS) to assess change between baseline, midpoint, group completion and 2 months post group.
20 item self-report measure of positive and negative affect
Time frame: Weeks 1, 4, 8 and 2 months post group completion
Patient Health Questionnaire - Somatic Anxiety Depression Scale (PHQ-SADS) to assess change between baseline, midpoint, group completion and 2 months post group.
Self-report scales that include the 9 questions for assessing depression; 7 questions for assessing general anxiety; and 15 questions for assessing somatic symptoms
Time frame: Weeks 1, 4, 8 and 2 months post group completion
Internalized Shame Scale to assess change between baseline, midpoint, group completion and 2 months post group.
30 item self-report scale that measures the phenomenology of the shame experience
Time frame: Weeks 1, 4, 8 and 2 months post group completion
World Health Organization Disability Assessment Schedule (WHODAS) to assess change between baseline, midpoint, group completion and 2 months post group.
12 item generic assessment instrument for health and disability
Time frame: Weeks 1, 4, 8 and 2 months post group completion
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University of Toronto Practice Based Research Network