Clinical trial NCT02987582: A Feasibility Study of an Emotion-Focused Mindfulness Group
Official title: A Feasibility Study of an Emotion-Focused Mindfulness Group to Enhance Coping and Resilience in Family Medicine Patients Living With Common Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: mental health
mindfulness
shame
Lead sponsor: University of Toronto Practice Based Research Network
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
First posted: 2016-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Compassion Scale (SCS) to assess change between baseline, midpoint, group completion and 2 months post group.
timeFrame: Weeks 1, 4, 8 and 2 months post group completion
Secondary outcomes:
measure: Positive and Negative Affect Scale (PANAS) to assess change between baseline, midpoint, group completion and 2 months post group.
timeFrame: Weeks 1, 4, 8 and 2 months post group completion
measure: Patient Health Questionnaire - Somatic Anxiety Depression Scale (PHQ-SADS) to assess change between baseline, midpoint, group completion and 2 months post group.
timeFrame: Weeks 1, 4, 8 and 2 months post group completion
measure: Internalized Shame Scale to assess change between baseline, midpoint, group completion and 2 months post group.
timeFrame: Weeks 1, 4, 8 and 2 months post group completion
measure: World Health Organization Disability Assessment Schedule (WHODAS) to assess change between baseline, midpoint, group completion and 2 months post group.
timeFrame: Weeks 1, 4, 8 and 2 months post group completion
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital, Canada
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Sinai Health System
name: Rodelyn Wisco, MSW
role: PRINCIPAL_INVESTIGATOR
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