NCT04778163

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

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

September 19, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2.8 years

First QC Date

January 30, 2021

Last Update Submit

October 31, 2022

Conditions

Keywords

Young peopleYoung adultsHumorPsychotherapyGroup psychotherapyResilience

Outcome Measures

Primary Outcomes (1)

  • 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.

    About three years

Secondary Outcomes (4)

  • Coping evolution using scale : Coping Humor Scale (from (-14) to (+14) : higher scores mean a better outcome).

    About three years

  • Psychiatric symptoms evolution using scale : Brief Psychiatric Rating Scale (from 24 to 168 : higher scores mean a worse outcome).

    About three years

  • Global functioning using scales : Global Assessment Functioning (from 1 to 100 : higher scores mean a better outcome).

    About three years

  • Clinical global impression using scale : Clinical Global Impression (from 1 to 7 : higher scores mean a worse outcome).

    About three years

Study Arms (2)

Humor group 1

EXPERIMENTAL

Group 1 - experimental - will participate in a "humor group" with a one-hour group session per week for 6 weeks.

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.

Interventions

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.

Also known as: Treatment, Group psychotherapy
Humor group 1

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Those who do not meet the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Programme JADE

Geneva, 1202, Switzerland

Location

Related Publications (16)

  • 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.

    PMID: 17435483BACKGROUND
  • Compas 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.

    PMID: 11271757BACKGROUND
  • Corcoran 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.

    PMID: 9134592BACKGROUND
  • Corrigan 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.

    PMID: 24727719BACKGROUND
  • Franzini 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.

    PMID: 11506047BACKGROUND
  • Valentine 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.

    PMID: 24430586BACKGROUND
  • Ventura 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.

    PMID: 11166085BACKGROUND
  • Derouesne 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.

    PMID: 27005341BACKGROUND
  • Etienne 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.

    PMID: 22516275BACKGROUND
  • McGhee, P. (1994). How to develop your sense of humor. Dubuque: Kendall Hunt.

    BACKGROUND
  • Rengade, C.E. (2014). L'humour en thérapie cognitive et comportementale. J thér comport cogn, 24(1), 1-4.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

  • Falkenberg 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.

  • 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.

Related Links

MeSH Terms

Conditions

Treatment Adherence and ComplianceMental Disorders

Interventions

TherapeuticsPsychotherapy, Group

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cédric AM Devillé, Dr

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 30, 2021

First Posted

March 2, 2021

Study Start

September 19, 2019

Primary Completion

June 30, 2022

Study Completion

October 31, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations