AzTrials
AzTrials

AnxietyNCT03147924

Examining the Effects of an Improvisation Group

A study testing Improvisation Group in people with Anxiety and Depression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 17 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression, Self Concept Alteration
What is being tested?
Improvisation Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteCanada
Study dates
6 Mar 2017to 31 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • help-seeking youth
  • ages 17-25

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Youth Wellness Centre

    Hamilton, Ontario, L9C3L7

Other trials in Canada

About this study

Official title: 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.

Being tested
Improvisation Group
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Improvisation GroupOther

    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.

Study groups in NCT03147924
Study groupRoleWhat they receive
Attending Improvisation GroupExperimentalAttended 3 or more Improvisation Group sessions
Receives: Other: Improvisation Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Change in Social Phobia Inventory (SPIN)

    A seventeen-item questionnaire used to measure the severity of social anxiety.

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

  3. Change in Subjective Units of Distress Scale (SUDS)

    A thermometer scale used to track anxiety before and after each session

    Measured: Pre and post every improv session for a duration of 12-weeks

Secondary outcomes (4)

  1. Change in Patient Health Questionnaire (PHQ-9)

    A nine-item questionnaire used to measure depression

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

  2. Change in Kessler Psychological Distress Scale (K-10)

    A 10-item questionnaire intended to measure distress based on questions about anxiety and depressive symptoms.

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

  3. Change in Rosenberg Self-Esteem Scale (RSES)

    A 10-item questionnaire used to measure self-esteem.

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

  4. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2017
  2. Study start6 Mar 2017
  3. Primary completion31 Aug 2017
  4. Study completion31 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03147924
Sponsor's protocol ID
2927
Status last verified
Apr 2018
First submitted
3 May 2017
Last updated
30 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20509987

  • 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.

    PubMed 24339820

  • 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.

    PubMed 26745687

  • 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.

    PubMed 10827888

  • 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.

    PubMed 24336308

  • 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.

    PubMed 25075171

  • 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.

    PubMed 12214795

  • 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.

    PubMed 15939839

  • 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.

    PubMed 25875938

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Improvisation Group in people with Anxiety and Depression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Generalized Anxiety Disorder 7 (GAD-7) (time frame: Pre-group and 12-weeks later (post group)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03147924, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in