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NCT Number: NCT02987582

A Feasibility Study of an Emotion-Focused Mindfulness Group

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Canada

Toronto, Ontario, M5T 3L9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotion-focused mindfulness group

Behavioral

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.

Primary outcomes

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

    Time frame: Weeks 1, 4, 8 and 2 months post group completion

    26 question self-administered questionnaire

Secondary outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Weeks 1, 4, 8 and 2 months post group completion

    12 item generic assessment instrument for health and disability

Sponsors and collaborators

Lead sponsor

University of Toronto Practice Based Research Network

Other

Collaborators

  • Mount Sinai Hospital, Canada

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2016
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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