A Feasibility Study of an Emotion-Focused Mindfulness Group

Sponsor
University of Toronto Practice Based Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT02987582
Collaborator
Mount Sinai Hospital, Canada (Other)
30
1
1
15
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Emotion-focused mindfulness group
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Emotion-focused mindfulness group

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.

Outcome Measures

Primary Outcome Measures

  1. Self-Compassion Scale (SCS) to assess change between baseline, midpoint, group completion and 2 months post group. [Weeks 1, 4, 8 and 2 months post group completion]

    26 question self-administered questionnaire

Secondary Outcome Measures

  1. Positive and Negative Affect Scale (PANAS) to assess change between baseline, midpoint, group completion and 2 months post group. [Weeks 1, 4, 8 and 2 months post group completion]

    20 item self-report measure of positive and negative affect

  2. Patient Health Questionnaire - Somatic Anxiety Depression Scale (PHQ-SADS) to assess change between baseline, midpoint, group completion and 2 months post group. [Weeks 1, 4, 8 and 2 months post group completion]

    Self-report scales that include the 9 questions for assessing depression; 7 questions for assessing general anxiety; and 15 questions for assessing somatic symptoms

  3. Internalized Shame Scale to assess change between baseline, midpoint, group completion and 2 months post group. [Weeks 1, 4, 8 and 2 months post group completion]

    30 item self-report scale that measures the phenomenology of the shame experience

  4. World Health Organization Disability Assessment Schedule (WHODAS) to assess change between baseline, midpoint, group completion and 2 months post group. [Weeks 1, 4, 8 and 2 months post group completion]

    12 item generic assessment instrument for health and disability

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Sinai Hospital, Canada Toronto Ontario Canada M5T 3L9

Sponsors and Collaborators

  • University of Toronto Practice Based Research Network
  • Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Rodelyn Wisco, MSW, Mount Sinai Hospital, Sinai Health System

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of Toronto Practice Based Research Network
ClinicalTrials.gov Identifier:
NCT02987582
Other Study ID Numbers:
  • EFM 1
First Posted:
Dec 9, 2016
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Toronto Practice Based Research Network
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2021