A Feasibility Study of an Emotion-Focused Mindfulness Group

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987582
• Other study ID #: EFM 1
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2021
• Source: University of Toronto Practice Based Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital, Canada	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto Practice Based Research Network	Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Canadian Psychiatric Association. Clinical practice guidelines. Management of anxiety disorders. Can J Psychiatry. 2006 Jul;51(8 Suppl 2):9S-91S. Review. Erratum in: Can J Psychiatry. 2006 Sep;51(10):623. — View Citation

Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. — View Citation

Gayner B, Esplen MJ, DeRoche P, Wong J, Bishop S, Kavanagh L, Butler K. A randomized controlled trial of mindfulness-based stress reduction to manage affective symptoms and improve quality of life in gay men living with HIV. J Behav Med. 2012 Jun;35(3):272-85. doi: 10.1007/s10865-011-9350-8. Epub 2011 May 20. — View Citation

Germer CK, Neff KD. Self-compassion in clinical practice. J Clin Psychol. 2013 Aug;69(8):856-67. doi: 10.1002/jclp.22021. Epub 2013 Jun 17. — View Citation

Kessler RC, Gruber M, Hettema JM, Hwang I, Sampson N, Yonkers KA. Co-morbid major depression and generalized anxiety disorders in the National Comorbidity Survey follow-up. Psychol Med. 2008 Mar;38(3):365-74. Epub 2007 Nov 30. — View Citation

Kroenke K, Spitzer RL, Williams JB, Monahan PO, Löwe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. — View Citation

Parikh SV, Segal ZV, Grigoriadis S, Ravindran AV, Kennedy SH, Lam RW, Patten SB; Canadian Network for Mood and Anxiety Treatments (CANMAT). Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults. II. Psychotherapy alone or in combination with antidepressant medication. J Affect Disord. 2009 Oct;117 Suppl 1:S15-25. doi: 10.1016/j.jad.2009.06.042. Epub 2009 Aug 13. — View Citation

Patten SB, Gordon-Brown L, Meadows G. Simulation studies of age-specific lifetime major depression prevalence. BMC Psychiatry. 2010 Oct 20;10:85. doi: 10.1186/1471-244X-10-85. — View Citation

Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV 3rd, Hahn SR, Brody D, Johnson JG. Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994 Dec 14;272(22):1749-56. — View Citation

Sundquist J, Lilja Å, Palmér K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27. — View Citation

Teasdale JD, Cox SG. Dysphoria: self-devaluative and affective components in recovered depressed patients and never depressed controls. Psychol Med. 2001 Oct;31(7):1311-6. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Behavioral Medicine: A Primary Care Approach
•   Canadian Psychiatric Association and The College of Family Physicians of Canada
•   Centre for Addiction and Mental Health. Mental Illness and Addictions: Facts and Statistics
•   National Institute for Health and Care Excellence. Depression in adults: recognition and management.
•   WHO. WHO Disability Assessment Schedule 2.0