A Feasibility Study of an Emotion-Focused Mindfulness Group

NCT02987582 | Completed

• 1 other identifier: EFM 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

mental health; mindfulness; shame

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Emotion-focused mindfulness group

EXPERIMENTAL

8-week mindfulness group

Behavioral: Emotion-focused mindfulness group

Interventions

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.

Emotion-focused mindfulness group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Mount Sinai Hospital, Canada

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (13)

• 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. doi: 10.1017/S0033291707002012. Epub 2007 Nov 30.

  PMID: 18047766 BACKGROUND

• 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.

  PMID: 20961404 BACKGROUND

• Sundquist J, Lilja A, Palmer 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.

  PMID: 25431430 BACKGROUND

• Canadian Psychiatric Association. Clinical practice guidelines. Management of anxiety disorders. Can J Psychiatry. 2006 Jul;51(8 Suppl 2):9S-91S. No abstract available.

  PMID: 16933543 BACKGROUND

• 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.

  PMID: 19682749 BACKGROUND

• 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. doi: 10.1017/s003329170100424x.

  PMID: 11681557 BACKGROUND

• 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.

  PMID: 21597980 BACKGROUND

• 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.

  PMID: 23775511 BACKGROUND

• 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. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• 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. doi: 10.1348/0144665031752934.

  PMID: 15333231 BACKGROUND

• 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.

  PMID: 7966923 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.

  PMID: 17339617 BACKGROUND

• 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. doi: 10.1097/00006842-200203000-00008.

  PMID: 11914441 BACKGROUND

Related Links

• 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
• Canadian Psychiatric Association and The College of Family Physicians of Canada
• Behavioral Medicine: A Primary Care Approach

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Rodelyn Wisco, MSW

  Mount Sinai Hospital, Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: December 9, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)