NCT03147924

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

May 3, 2017

Last Update Submit

April 27, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (4)

  • Change in Patient Health Questionnaire (PHQ-9)

    Pre-group and 12-weeks later (post group)

  • Change in Kessler Psychological Distress Scale (K-10)

    Pre-group and 12-weeks later (post group)

  • Change in Rosenberg Self-Esteem Scale (RSES)

    Pre-group and 12-weeks later (post group)

  • Change in Multidimensional Scale of Perceived Social Support (MSPSS)

    Pre-group and 12-weeks later (post group)

Study Arms (1)

Attending Improvisation Group

EXPERIMENTAL

Attended 3 or more Improvisation Group sessions

Other: Improvisation Group

Interventions

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.

Attending Improvisation Group

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • help-seeking youth
  • ages 17-25

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youth Wellness Centre

Hamilton, Ontario, L9C3L7, Canada

Location

Related 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20509987BACKGROUND
  • 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.

    PMID: 24339820BACKGROUND
  • 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.

    PMID: 26745687BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 10827888BACKGROUND
  • 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.

    PMID: 24336308BACKGROUND
  • 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.

    PMID: 25075171BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12214795BACKGROUND
  • 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.

    PMID: 15939839BACKGROUND
  • 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.

    PMID: 25875938BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 24691406BACKGROUND
  • 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.

    PMID: 26813204BACKGROUND
  • 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.

    PMID: 25350675BACKGROUND
  • 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.

    PMID: 24337476BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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

    BACKGROUND
  • Yorton, T. (2005). Using Improv Methods to Overcome the Fear Factor. Wiley Periodicals. doi: 10.1002/ert.20036

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Juliana Tobon, PhD.,C.Psych

    St. Joseph's Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 10, 2017

Study Start

March 6, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

April 30, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations