A Feasibility Study of an Emotion-Focused Mindfulness Group

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Feasibility Study of an Emotion-Focused Mindfulness Group to Enhance Coping and Resilience in Family Medicine Patients Living With Common Mental Illness

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Emotion-focused mindfulness group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be patient of Mount Sinai Academic Family Health Team Adults over the age of 18 years Symptoms of depression and anxiety as identified by the patient and/or family physician Sufficient English language skills to participate in the group (based on assessment of group facilitators) Committed and willing to engage in the group work, such as listening to others, speaking in front of others (based on assessment of group facilitators) Exclusion Criteria: (each based on assessment by group facilitators) Active suicidality Severe depression Possible alcohol abuse High tendency to dissociate Personality style that may disrupt group formation processes, participation in interpersonal group processes, and/or developing a meditation practice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotion-focused mindfulness group<br>8-week mindfulness group | Behavioral: Emotion-focused mindfulness group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Compassion Scale (SCS) to assess change between baseline, midpoint, group completion and 2 months post group. | 26 question self-administered questionnaire | Weeks 1, 4, 8 and 2 months post group completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Weeks 1, 4, 8 and 2 months post group completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shame, mental health, mindfulness