- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03147924
Examining the Effects of an Improvisation Group
April 27, 2018 updated by: Juliana Tobon, St. Joseph's Healthcare Hamilton
Examining the Effects of an Improvisation Group on Social Anxiety Among Help-seeking Youth
This study is taking place to examine the preliminary effects of improvisational therapy (improv group) on social anxiety for youth at the Youth Wellness Centre (YWC).
The improv group will run for 12-weeks as a drop-in group.
A typical session will begin with stretching, simple breathing and an activity to promote group cohesion.
Following this, improvisation games and activities will be introduced with the goal of promoting the following skills: assertiveness, acceptance, problem solving, co-operate skills, non-verbal communication, mindfulness, and memory.
Youth who consent to the study will be asked to complete a set of brief questionnaires the first time they attend one of the sessions.
Youth who have attended at least 3 sessions will be asked again to complete questionnaires following the completion of week 12 session.
Youth will also rate their anxiety and distress on a simple rating scale at the beginning and end of each session.
Additionally, all participants (who have attended three or more sessions) will be invited to complete a 30 to 45 minute qualitative interview following the 12 week session.
Participants are predicted to show a decrease in social anxiety, generalized anxiety and depression symptoms, and an increase in self-esteem, and perceived social support.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L9C3L7
- Youth Wellness Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 25 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- help-seeking youth
- ages 17-25
Exclusion Criteria:
- will NOT be excluded on the basis of mental health or addiction concerns
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Attending Improvisation Group
Attended 3 or more Improvisation Group sessions
|
The aim of this pilot study is to investigate the effects of improvisational comedy in a group of help-seeking youth at risk of developing a range of mental health disorders, including social anxiety.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Generalized Anxiety Disorder 7 (GAD-7)
Time Frame: Pre-group and 12-weeks later (post group)
|
A seven-item self-report anxiety questionnaire designed to monitor and assess the severity of generalized anxiety disorder (GAD) symptoms.
|
Pre-group and 12-weeks later (post group)
|
Change in Social Phobia Inventory (SPIN)
Time Frame: Pre-group and 12-weeks later (post group)
|
A seventeen-item questionnaire used to measure the severity of social anxiety.
|
Pre-group and 12-weeks later (post group)
|
Change in Subjective Units of Distress Scale (SUDS)
Time Frame: Pre and post every improv session for a duration of 12-weeks
|
A thermometer scale used to track anxiety before and after each session
|
Pre and post every improv session for a duration of 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Health Questionnaire (PHQ-9)
Time Frame: Pre-group and 12-weeks later (post group)
|
A nine-item questionnaire used to measure depression
|
Pre-group and 12-weeks later (post group)
|
Change in Kessler Psychological Distress Scale (K-10)
Time Frame: Pre-group and 12-weeks later (post group)
|
A 10-item questionnaire intended to measure distress based on questions about anxiety and depressive symptoms.
|
Pre-group and 12-weeks later (post group)
|
Change in Rosenberg Self-Esteem Scale (RSES)
Time Frame: Pre-group and 12-weeks later (post group)
|
A 10-item questionnaire used to measure self-esteem.
|
Pre-group and 12-weeks later (post group)
|
Change in Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Pre-group and 12-weeks later (post group)
|
A 12-item questionnaire designed to measure perception of support from 3 sources: family, friends and significant other
|
Pre-group and 12-weeks later (post group)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juliana Tobon, PhD.,C.Psych, St. Joseph's Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617. Erratum In: Arch Gen Psychiatry. 2005 Jul;62(7):709. Merikangas, Kathleen R [added].
- Akinsola, E.F., & Udoka, P.A.. Parental Influence on Social Anxiety in Children and Adolescents: Its Assessment and Management Using Psychodrama. Psychology. 4(3A), 246-253, 2013.
- Albano, A. M. & Kendall, P.C. (2002). Cognitive Behavioural Therapy for Children and Adolescents with Anxiety Disorders: Clinical Research Advances. International Review of Psychiatry, 14, 129-134.
- Bagley C, Bolitho F, Bertrand L. Norms and Construct Validity of the Rosenberg Self-Esteem Scale in Canadian High School Populations: Implications for counselling. Canadian Journal of Counselling. 1997;31(1):82.
- Benjamin CL, O'Neil KA, Crawley SA, Beidas RS, Coles M, Kendall PC. Patterns and predictors of subjective units of distress in anxious youth. Behav Cogn Psychother. 2010 Jul;38(4):497-504. doi: 10.1017/S1352465810000287. Epub 2010 May 28.
- Bermant G. Working with(out) a net: improvisational theater and enhanced well-being. Front Psychol. 2013 Dec 10;4:929. doi: 10.3389/fpsyg.2013.00929. eCollection 2013. No abstract available.
- Besser A, Weinberg M, Zeigler-Hill V, Ataria Y, Neria Y. Humor and Trauma-Related Psychopathology Among Survivors of Terror Attacks and Their Spouses. Psychiatry. 2015;78(4):341-53. doi: 10.1080/00332747.2015.1061312.
- Butler, M. & Pang, M. (2014). Current Issues in Mental Health in Canada: Child and Youth Mental Health. Parliamentary Information and Research Service, Library of Parliament, Publication no. 2014-13.
- Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.
- Ferner RE, Aronson JK. Laughter and MIRTH (Methodical Investigation of Risibility, Therapeutic and Harmful): narrative synthesis. BMJ. 2013 Dec 12;347:f7274. doi: 10.1136/bmj.f7274.
- Hayes SA, Miller NA, Hope DA, Heimberg RG, Juster HR. Assessing Client Progress Session by Session in the Treatment of Social Anxiety Disorder: The Social Anxiety Session Change Index. Cogn Behav Pract. 2008 May 1;15(2):203-2011. doi: 10.1016/j.cbpra.2007.02.010.
- Kendall, P.C., Robin, J.A., Hedtke, K.A., Suveg, C., Flannery-Schroeder, E. & Gosch, E. (2005). Considering CBT with Anxious Youth? Think Exposures. Cognitive and Behavioural Practice, 12, 136-150.
- Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.
- Kim SH, Kook JR, Kwon M, Son MH, Ahn SD, Kim YH. The effects of laughter therapy on mood state and self-esteem in cancer patients undergoing radiation therapy: a randomized controlled trial. J Altern Complement Med. 2015 Apr;21(4):217-22. doi: 10.1089/acm.2014.0152.
- Kindler, R.C. & Gray, A.A. (2010). Theater and Therapy: How Improvisation Informs the Analytic Hour. Psychoanalytic Inquiry, 30, 254-266. doi: 10.1080/07351690903206223
- Mesa F, Beidel DC, Bunnell BE. An examination of psychopathology and daily impairment in adolescents with social anxiety disorder. PLoS One. 2014 Apr 1;9(4):e93668. doi: 10.1371/journal.pone.0093668. eCollection 2014.
- Misch DA. A PIECE OF MY MIND. I Feel Witty, Oh So Witty. JAMA. 2016 Jan 26;315(4):345-6. doi: 10.1001/jama.2015.16758. No abstract available.
- Palinkas LA. Qualitative and mixed methods in mental health services and implementation research. J Clin Child Adolesc Psychol. 2014;43(6):851-61. doi: 10.1080/15374416.2014.910791.
- Rudnick A, Kohn PM, Edwards KR, Podnar D, Caird S, Martin R. Humour-related interventions for people with mental illness: a randomized controlled pilot study. Community Ment Health J. 2014 Aug;50(6):737-42. doi: 10.1007/s10597-013-9685-4. Epub 2013 Dec 12.
- Sheesley, A.P., Pfeffer, M. & Barish, B. (2016). Comedic Improv Therapy for the Treatment of Social Anxiety Disorder. Journal of Creativity in Mental Health. 11(2), 157-169. doi: 10.1080/15401383.2016
- Steitzer, C. (2011). The Brilliant Genius: Using Improv Comedy in Social Work Groups. Social Worker with Groups, 34, 270-282. doi: 10.1080/01609513.2011.558830
- Yorton, T. (2005). Using Improv Methods to Overcome the Fear Factor. Wiley Periodicals. doi: 10.1002/ert.20036
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 6, 2017
Primary Completion (ACTUAL)
August 31, 2017
Study Completion (ACTUAL)
August 31, 2017
Study Registration Dates
First Submitted
May 3, 2017
First Submitted That Met QC Criteria
May 8, 2017
First Posted (ACTUAL)
May 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 30, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2927
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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