Treatment Adherence and ComplianceNCT04778163
The Use of Humor With Young Adults in Psychiatric Care
A study testing Clinical use of humor in people with Treatment Adherence and Compliance and Psychiatric Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Treatment Adherence and Compliance, Psychiatric Disorder
- What is being tested?
- Clinical use of humor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Sep 2019to 31 Oct 2022
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Those who do not meet the above criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Clinical use of humor
- Keywords
- Young people, Young adults, Humor, Psychotherapy, Group psychotherapy, Resilience
- Medical subject headings
- Treatment Adherence and Compliance, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical use of humorBehavioural
Also called Treatment, Group psychotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Humor group 1 | Experimental | Group 1 - experimental - will participate in a "humor group" with a one-hour group session per week for 6 weeks. Receives: Behavioral: Clinical use of humor |
| Control group 2 | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: About three years
Secondary outcomes (4)
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.
Measured: About three years
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.
Measured: About three years
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.
Measured: About three years
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.
Measured: About three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start19 Sep 2019
- Primary completion30 Jun 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Treatment Adherence and ComplianceStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cédric DEVILLE, University Hospital, Geneva
- Investigators
- Cédric AM Devillé, Dr, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778163
- Sponsor's protocol ID
- CDEVILLE
- Status last verified
- Oct 2022
- First submitted
- 30 Jan 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bozikas VP, Kosmidis MH, Giannakou M, Anezoulaki D, Petrikis P, Fokas K, Karavatos A. Humor appreciation deficit in schizophrenia: the relevance of basic neurocognitive functioning. J Nerv Ment Dis. 2007 Apr;195(4):325-31. doi: 10.1097/01.nmd.0000243798.10242.e2.
PubMed 17435483Compas BE, Connor-Smith JK, Saltzman H, Thomsen AH, Wadsworth ME. Coping with stress during childhood and adolescence: problems, progress, and potential in theory and research. Psychol Bull. 2001 Jan;127(1):87-127.
PubMed 11271757Corcoran R, Cahill C, Frith CD. The appreciation of visual jokes in people with schizophrenia: a study of 'mentalizing' ability. Schizophr Res. 1997 Apr 11;24(3):319-27. doi: 10.1016/s0920-9964(96)00117-x.
PubMed 9134592Corrigan PW, Powell KJ, Fokuo JK, Kosyluk KA. Does humor influence the stigma of mental illnesses? J Nerv Ment Dis. 2014 May;202(5):397-401. doi: 10.1097/NMD.0000000000000138.
PubMed 24727719Franzini LR. Humor in therapy: the case for training therapists in its uses and risks. J Gen Psychol. 2001 Apr;128(2):170-93. doi: 10.1080/00221300109598906.
PubMed 11506047Valentine L, Gabbard GO. Can the use of humor in psychotherapy be taught? Acad Psychiatry. 2014 Feb;38(1):75-81. doi: 10.1007/s40596-013-0018-2.
PubMed 24430586Ventura J, Nuechterlein KH, Subotnik KL, Gutkind D, Gilbert EA. Symptom dimensions in recent-onset schizophrenia and mania: a principal components analysis of the 24-item Brief Psychiatric Rating Scale. Psychiatry Res. 2000 Dec 27;97(2-3):129-35. doi: 10.1016/s0165-1781(00)00228-6.
PubMed 11166085Derouesne C. [Neuropsychology of humor: an introduction Part 1. Psychological data]. Geriatr Psychol Neuropsychiatr Vieil. 2016 Mar;14(1):95-103. doi: 10.1684/pnv.2016.0583. French.
PubMed 27005341Etienne E, Braha S, Januel D. [Humour and the theory of mind in schizophrenia: a review of the literature]. Encephale. 2012 Apr;38(2):164-9. doi: 10.1016/j.encep.2011.03.008. Epub 2011 Jul 5. French.
PubMed 22516275McGhee, P. (1994). How to develop your sense of humor. Dubuque: Kendall Hunt.
Rengade, C.E. (2014). L'humour en thérapie cognitive et comportementale. J thér comport cogn, 24(1), 1-4.
Salameh, W.A. (1983). Humor in psychotherapy: past outlooks, present status, and future frontiers. In: McGhee, P.E., Goldstein, J.H., editors. Handbook of humor research. Volume II Applied studies. New York: Springer, 61-88.
Ventura, J., Green, M.F., Shaner, A., Liberman, R.P. (1993). Training and quality assurance with the Brief Psychiatric Rating Scale: "The drift busters". International Journal of Methods in Psychiatry Research, 3, 221-224.
Cai C, Yu L, Rong L, Zhong H. Effectiveness of humor intervention for patients with schizophrenia: a randomized controlled trial. J Psychiatr Res. 2014 Dec;59:174-8. doi: 10.1016/j.jpsychires.2014.09.010. Epub 2014 Sep 19.
PubMed 25266473Falkenberg I, Buchkremer G, Bartels M, Wild B. Implementation of a manual-based training of humor abilities in patients with depression: a pilot study. Psychiatry Res. 2011 Apr 30;186(2-3):454-7. doi: 10.1016/j.psychres.2010.10.009. Epub 2010 Nov 11.
PubMed 21071099
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Humor With Young Adults in Psychiatric Care
- ClinicalTrials.gov ID
- NCT04778163
- Acronym / sponsor ID
- CDEVILLE
- Keywords
- Young people, Young adults, Humor, Psychotherapy, Group psychotherapy, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Humor group 1 | Experimental | Behavioral: Clinical use of humorGroup 1 - experimental - will participate in a "humor group" with a one-hour group session per week for 6 weeks. |
| Control group 2 | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who do not meet the above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical use of humorAlso: Treatment, Group psychotherapyClinical 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. | Behavioural | Humor group 1 |
Primary outcome
Primary outcome is sense of humor using scale : Sense of Humor Scale (from 36 to 144 : higher scores mean a better outcome).
Time frame: About three years
To evaluate whether or not their appreciation/use of humor has improved.
4 secondary outcomes
Coping evolution using scale : Coping Humor Scale (from (-14) to (+14) : higher scores mean a better outcome).
Time frame: About three years
Psychiatric symptoms evolution using scale : Brief Psychiatric Rating Scale (from 24 to 168 : higher scores mean a worse outcome).
Time frame: About three years
Global functioning using scales : Global Assessment Functioning (from 1 to 100 : higher scores mean a better outcome).
Time frame: About three years
Clinical global impression using scale : Clinical Global Impression (from 1 to 7 : higher scores mean a worse outcome).
Time frame: About three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 17435483Bozikas VP, Kosmidis MH, Giannakou M, Anezoulaki D, Petrikis P, Fokas K, Karavatos A. Humor appreciation deficit in schizophrenia: the relevance of basic neurocognitive functioning. J Nerv Ment Dis. 2007 Apr;195(4):325-31. doi: 10.1097/01.nmd.0000243798.10242.e2.
- Background: PubMed 11271757Compas BE, Connor-Smith JK, Saltzman H, Thomsen AH, Wadsworth ME. Coping with stress during childhood and adolescence: problems, progress, and potential in theory and research. Psychol Bull. 2001 Jan;127(1):87-127.
- Background: PubMed 9134592Corcoran R, Cahill C, Frith CD. The appreciation of visual jokes in people with schizophrenia: a study of 'mentalizing' ability. Schizophr Res. 1997 Apr 11;24(3):319-27. doi: 10.1016/s0920-9964(96)00117-x.
- Background: PubMed 24727719Corrigan PW, Powell KJ, Fokuo JK, Kosyluk KA. Does humor influence the stigma of mental illnesses? J Nerv Ment Dis. 2014 May;202(5):397-401. doi: 10.1097/NMD.0000000000000138.
- Background: PubMed 11506047Franzini LR. Humor in therapy: the case for training therapists in its uses and risks. J Gen Psychol. 2001 Apr;128(2):170-93. doi: 10.1080/00221300109598906.
- Background: PubMed 24430586Valentine L, Gabbard GO. Can the use of humor in psychotherapy be taught? Acad Psychiatry. 2014 Feb;38(1):75-81. doi: 10.1007/s40596-013-0018-2.
- Background: PubMed 11166085Ventura J, Nuechterlein KH, Subotnik KL, Gutkind D, Gilbert EA. Symptom dimensions in recent-onset schizophrenia and mania: a principal components analysis of the 24-item Brief Psychiatric Rating Scale. Psychiatry Res. 2000 Dec 27;97(2-3):129-35. doi: 10.1016/s0165-1781(00)00228-6.
- Background: PubMed 27005341Derouesne C. [Neuropsychology of humor: an introduction Part 1. Psychological data]. Geriatr Psychol Neuropsychiatr Vieil. 2016 Mar;14(1):95-103. doi: 10.1684/pnv.2016.0583. French.
- Background: PubMed 22516275Etienne E, Braha S, Januel D. [Humour and the theory of mind in schizophrenia: a review of the literature]. Encephale. 2012 Apr;38(2):164-9. doi: 10.1016/j.encep.2011.03.008. Epub 2011 Jul 5. French.
- BackgroundMcGhee, P. (1994). How to develop your sense of humor. Dubuque: Kendall Hunt.
- BackgroundRengade, C.E. (2014). L'humour en thérapie cognitive et comportementale. J thér comport cogn, 24(1), 1-4.
- BackgroundSalameh, W.A. (1983). Humor in psychotherapy: past outlooks, present status, and future frontiers. In: McGhee, P.E., Goldstein, J.H., editors. Handbook of humor research. Volume II Applied studies. New York: Springer, 61-88.
- Association for Applied and Therapeutic HumorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric AM Devillé, Dr principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical use of humor in people with Treatment Adherence and Compliance and Psychiatric Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 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 1 Nov 2022. 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 Switzerland. 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?
Primary outcome is sense of humor using scale : Sense of Humor Scale (from 36 to 144 : higher scores mean a better outcome). (time frame: About three years). 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 NCT04778163, which also lists 16 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 1 Nov 2022.