- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02987582
A Feasibility Study of an Emotion-Focused Mindfulness Group
A Feasibility Study of an Emotion-Focused Mindfulness Group to Enhance Coping and Resilience in Family Medicine Patients Living With Common Mental Illness
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 3L9
- Mount Sinai Hospital, Canada
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Emotion-focused mindfulness group
8-week 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Weeks 1, 4, 8 and 2 months post group completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
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
|
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.
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
|
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.
Time Frame: Weeks 1, 4, 8 and 2 months post group completion
|
12 item generic assessment instrument for health and disability
|
Weeks 1, 4, 8 and 2 months post group completion
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rodelyn Wisco, MSW, Mount Sinai Hospital, Sinai Health System
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Canadian Psychiatric Association. Clinical practice guidelines. Management of anxiety disorders. Can J Psychiatry. 2006 Jul;51(8 Suppl 2):9S-91S. No abstract available. Erratum In: Can J Psychiatry. 2006 Sep;51(10):623.
- 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.
- 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.
- 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.
- 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.
Helpful 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFM 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Emotion-focused mindfulness group
-
Stacey HatchCompleted
-
Instituto Portugues de Oncologia, Francisco Gentil...Linnaeus University; University of Oulu; European Commission; Polytechnic Institute... and other collaboratorsUnknown
-
University of ChicagoCompleted
-
University of TorontoRecruiting
-
Institutt for Psykologisk RadgivningUniversity of Oslo; University of Bergen; The Research Council of NorwayCompletedF01.318 Child Rearing | F01.470 Emotions | F01.145.179 Child BehaviorNorway
-
Islamic Azad University, Najafabad BranchCompletedFunctional Gastrointestinal Disorders
-
University of GuelphRecruitingDepression | Anxiety | Behavior ProblemCanada
-
Mark A. LumleyCompleted
-
Region StockholmRecruiting
-
Fundació Institut de Recerca de l'Hospital de la...CompletedMajor Depressive Disorder