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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03147924
Other study ID # 2927
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2017
Est. completion date August 31, 2017

Study information

Verified date April 2018
Source St. Joseph's Healthcare Hamilton
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date August 31, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 25 Years
Eligibility Inclusion Criteria:

- help-seeking youth

- ages 17-25

Exclusion Criteria:

- will NOT be excluded on the basis of mental health or addiction concerns

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Improvisation Group
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.

Locations

Country Name City State
Canada Youth Wellness Centre Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Arch Gen Psychiatry. 2005 Jul;62(7):709. Merikangas, Kathleen R [added]. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

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

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Generalized Anxiety Disorder 7 (GAD-7) 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)
Primary Change in Social Phobia Inventory (SPIN) A seventeen-item questionnaire used to measure the severity of social anxiety. Pre-group and 12-weeks later (post group)
Primary Change in Subjective Units of Distress Scale (SUDS) 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 Change in Patient Health Questionnaire (PHQ-9) A nine-item questionnaire used to measure depression Pre-group and 12-weeks later (post group)
Secondary Change in Kessler Psychological Distress Scale (K-10) A 10-item questionnaire intended to measure distress based on questions about anxiety and depressive symptoms. Pre-group and 12-weeks later (post group)
Secondary Change in Rosenberg Self-Esteem Scale (RSES) A 10-item questionnaire used to measure self-esteem. Pre-group and 12-weeks later (post group)
Secondary Change in Multidimensional Scale of Perceived Social Support (MSPSS) 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)
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