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Examining the Effects of an Improvisation Group

Primary Purpose

Anxiety, Depression, Self Concept Alteration

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Improvisation Group
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

17 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • help-seeking youth
  • ages 17-25

Exclusion Criteria:

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

Sites / Locations

  • Youth Wellness Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Attending Improvisation Group

Arm Description

Attended 3 or more Improvisation Group sessions

Outcomes

Primary Outcome Measures

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.
Change in Social Phobia Inventory (SPIN)
A seventeen-item questionnaire used to measure the severity of social anxiety.
Change in Subjective Units of Distress Scale (SUDS)
A thermometer scale used to track anxiety before and after each session

Secondary Outcome Measures

Change in Patient Health Questionnaire (PHQ-9)
A nine-item questionnaire used to measure depression
Change in Kessler Psychological Distress Scale (K-10)
A 10-item questionnaire intended to measure distress based on questions about anxiety and depressive symptoms.
Change in Rosenberg Self-Esteem Scale (RSES)
A 10-item questionnaire used to measure self-esteem.
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

Full Information

First Posted
May 3, 2017
Last Updated
April 27, 2018
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT03147924
Brief Title
Examining the Effects of an Improvisation Group
Official Title
Examining the Effects of an Improvisation Group on Social Anxiety Among Help-seeking Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Self Concept Alteration, Social Support

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attending Improvisation Group
Arm Type
Experimental
Arm Description
Attended 3 or more Improvisation Group sessions
Intervention Type
Other
Intervention Name(s)
Improvisation Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder 7 (GAD-7)
Description
A seven-item self-report anxiety questionnaire designed to monitor and assess the severity of generalized anxiety disorder (GAD) symptoms.
Time Frame
Pre-group and 12-weeks later (post group)
Title
Change in Social Phobia Inventory (SPIN)
Description
A seventeen-item questionnaire used to measure the severity of social anxiety.
Time Frame
Pre-group and 12-weeks later (post group)
Title
Change in Subjective Units of Distress Scale (SUDS)
Description
A thermometer scale used to track anxiety before and after each session
Time Frame
Pre and post every improv session for a duration of 12-weeks
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9)
Description
A nine-item questionnaire used to measure depression
Time Frame
Pre-group and 12-weeks later (post group)
Title
Change in Kessler Psychological Distress Scale (K-10)
Description
A 10-item questionnaire intended to measure distress based on questions about anxiety and depressive symptoms.
Time Frame
Pre-group and 12-weeks later (post group)
Title
Change in Rosenberg Self-Esteem Scale (RSES)
Description
A 10-item questionnaire used to measure self-esteem.
Time Frame
Pre-group and 12-weeks later (post group)
Title
Change in Multidimensional Scale of Perceived Social Support (MSPSS)
Description
A 12-item questionnaire designed to measure perception of support from 3 sources: family, friends and significant other
Time Frame
Pre-group and 12-weeks later (post group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: help-seeking youth ages 17-25 Exclusion Criteria: will NOT be excluded on the basis of mental health or addiction concerns
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Tobon, PhD.,C.Psych
Organizational Affiliation
St. Joseph's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youth Wellness Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9C3L7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Examining the Effects of an Improvisation Group

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