The Use of Humor With Young Adults in Psychiatric Care
Primary Purpose
Treatment Adherence and Compliance, Psychiatric Disorder
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Clinical use of humor
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Adherence and Compliance focused on measuring Young people, Young adults, Humor, Psychotherapy, Group psychotherapy, Resilience
Eligibility Criteria
Inclusion Criteria:
- Young adult patients of a psychiatric's unit (young people from 18 to 25 years old with beginner psychic disorders) who are French-speaking and able to give their informed consent.
Exclusion Criteria:
- Those who do not meet the above criteria.
Sites / Locations
- Programme JADE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Humor group 1
Control group 2
Arm Description
Group 1 - experimental - will participate in a "humor group" with a one-hour group session per week for 6 weeks.
Group 2 - the control group - will follow an usual treatment regimen for 6 weeks. At the end of the "Humor Group" of group 1, the 2 groups of patients will undergo a second series of tests identical to those of the pregroup. The paired patients should be randomly assigned. The control group will do the "Humor Group" after 6 weeks.
Outcomes
Primary Outcome Measures
Primary outcome is sense of humor using scale : Sense of Humor Scale (from 36 to 144 : higher scores mean a better outcome).
To evaluate whether or not their appreciation/use of humor has improved.
Secondary Outcome Measures
Coping evolution using scale : Coping Humor Scale (from (-14) to (+14) : higher scores mean a better outcome).
To evaluate whether or not the coping evolution has improved.
Psychiatric symptoms evolution using scale : Brief Psychiatric Rating Scale (from 24 to 168 : higher scores mean a worse outcome).
To evaluate whether or not the overall psychiatric symptomatology has improved.
Global functioning using scales : Global Assessment Functioning (from 1 to 100 : higher scores mean a better outcome).
To evaluate whether or not the overall functioning has improved.
Clinical global impression using scale : Clinical Global Impression (from 1 to 7 : higher scores mean a worse outcome).
To evaluate whether or not the overall global clinical impression has improved.
Full Information
NCT ID
NCT04778163
First Posted
January 30, 2021
Last Updated
October 31, 2022
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT04778163
Brief Title
The Use of Humor With Young Adults in Psychiatric Care
Official Title
The Use of Humor With Young Adults in Psychiatric Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
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
Clinical study in psychiatry in young adult patients between 18 and 25 years old. The aim of the study is to evaluate the therapeutic impact of the clinical use of humor through 6 group sessions (group of 5 to 10 patients), at the rate of one hour session per week for 6 weeks.
The investigators will form 2 groups of 5 to 10 patients matched in terms of gender, education level and score on a scale measuring their sense of humor. The participants will be asked to complete a series of tests measuring their ability to use humor, psychiatric symptoms and well-being.
Group 1 (test group) will participate in the humor-based sessions, while Group 2 (control group) will receive regular treatment for 6 weeks (waiting list: patients in Group 2 will attend humor-based sessions once Group 1 has completed their 6 weeks).
At the end of the 6-week sessions, both groups will receive the same series of pre-session tests to see whether or not there has been improvement in their overall functioning, psychiatric symptomatology and appreciation/use of humor.
At the end of the 2x 6-week sessions, group 2 will again receive this series of pre-session tests to see whether or not their overall functioning, psychiatric symptomatology and appreciation/use of humour has improved.
Objective(s)/Aim:
To evaluate the resilience of young adult psychiatric patients and their ability to cope with stress through the use of humor in a set of 6 modules on the use of humor.
To evaluate the symptoms.
Outcome/Endpoints :
Using scales, measure this evolution.
Detailed Description
Project design and procedures :
The investigators will form 2 groups of 5 to 10 patients matched on their score on the sense of humor scale, their gender and their level of education. The participants will be asked to complete a series of tests measuring their ability to use humor, clinical variables and general functioning.
Group 1 - experimental - will participate in a "humor group" with a one-hour group session per week for 6 weeks.
Group 2 - the control group - will follow a usual treatment regimen for 6 weeks. At the end of the "Humor Group" of group 1, the 2 groups of patients will undergo a second series of tests identical to those of the pregroup. The paired patients should be randomly assigned. The control group will do the "Humor Group" after 6 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Adherence and Compliance, Psychiatric Disorder
Keywords
Young people, Young adults, Humor, Psychotherapy, Group psychotherapy, Resilience
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A treatment arm receives a psychotherapeutic group intervention (based on humor with cognitive behavioural and psychoeducative approaches) over a period 6 weeks.
A control arm is placed on a 6 week waiting list.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Humor group 1
Arm Type
Experimental
Arm Description
Group 1 - experimental - will participate in a "humor group" with a one-hour group session per week for 6 weeks.
Arm Title
Control group 2
Arm Type
No Intervention
Arm Description
Group 2 - the control group - will follow an usual treatment regimen for 6 weeks. At the end of the "Humor Group" of group 1, the 2 groups of patients will undergo a second series of tests identical to those of the pregroup. The paired patients should be randomly assigned. The control group will do the "Humor Group" after 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Clinical use of humor
Other Intervention Name(s)
Treatment, Group psychotherapy
Intervention Description
Clinical study in psychiatry in young adult patients between 18 and 25 years old. The aim of the study is to evaluate the therapeutic impact of the clinical use of humor through 6 group sessions (group of 5 to 10 patients), at the rate of one hour session per week for 6 weeks.
The investigators will form 2 groups of 5 to 10 patients matched in terms of gender, education level and score on a scale measuring their sense of humor. The participants will be asked to complete a series of tests measuring their ability to use humor, psychiatric symptoms and well-being.
Primary Outcome Measure Information:
Title
Primary outcome is sense of humor using scale : Sense of Humor Scale (from 36 to 144 : higher scores mean a better outcome).
Description
To evaluate whether or not their appreciation/use of humor has improved.
Time Frame
About three years
Secondary Outcome Measure Information:
Title
Coping evolution using scale : Coping Humor Scale (from (-14) to (+14) : higher scores mean a better outcome).
Description
To evaluate whether or not the coping evolution has improved.
Time Frame
About three years
Title
Psychiatric symptoms evolution using scale : Brief Psychiatric Rating Scale (from 24 to 168 : higher scores mean a worse outcome).
Description
To evaluate whether or not the overall psychiatric symptomatology has improved.
Time Frame
About three years
Title
Global functioning using scales : Global Assessment Functioning (from 1 to 100 : higher scores mean a better outcome).
Description
To evaluate whether or not the overall functioning has improved.
Time Frame
About three years
Title
Clinical global impression using scale : Clinical Global Impression (from 1 to 7 : higher scores mean a worse outcome).
Description
To evaluate whether or not the overall global clinical impression has improved.
Time Frame
About three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Young adult patients of a psychiatric's unit (young people from 18 to 25 years old with beginner psychic disorders) who are French-speaking and able to give their informed consent.
Exclusion Criteria:
Those who do not meet the above criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cédric AM Devillé, Dr
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Programme JADE
City
Geneva
ZIP/Postal Code
1202
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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17435483
Citation
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Links:
URL
http://www.aath.org/
Description
Association for Applied and Therapeutic Humor
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The Use of Humor With Young Adults in Psychiatric Care
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