Trial document





This trial has been registered retrospectively.
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  DRKS00012443

Trial Description

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Title

Humor training for people with mental disorders – a randomized controlled trial

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Trial Acronym

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URL of the Trial

https://humortraining.jimdo.com/

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Brief Summary in Lay Language

This study implements a seven-week humor training for people with mental disorders. In the humor training participants relearn their own sense of humor and laughter and especially learn how to use humor in stressful situations to better cope with them. The manual is based on the manual of Falkenberg, McGhee and Wild (2013) "Humorfähigkeit trainieren - Manual für die psychiatrisch-psychotherapeutische Praxis". People can participate in the study if they have one of the following mental disorders: depression mild to moderate pronounced, anxiety disorder or adjustment disorder.
Studys show that humor trainings help increase constructs like coping humor, cheerfulness or well-being whilst diminishing psychopathology like depression or anxiety. However, studies were conducted primarily with healthy participants. Studies, that deal with humor and mental disorders are scarce. Because of that, this study wants to find out if humor trainings for people with mental disorders are also as effective as for people without mental disorders.

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Brief Summary in Scientific Language

The study deals with the promotion of coping humor and cheerfulness for people with mental disorders. In a seven-week humor training participants learn different strategies for using humor in everyday life and especially in stressful situations. The study has a randomized-controlled design (RCT) with an experimental group und a wait-list control group. The manual is based on the manual of Falkenberg, McGhee and Wild (2013) “Humorfähigkeit trainieren – Manual für die psychiatrisch-psychotherapeutische Praxis”. People can participate in the study if they have one of the following mental disorders: depression mild to moderate pronounced, anxiety disorder or adjustment disorder. Before the training a diagnostical interview is made to control for the inclusion and exclusion criteria.
Studies already show that humor trainings can help to increase cheerfulness and well-being and can also help to reduce depression and anxiety. However, studies were conducted primarily with healthy participants. Studies that deal with humor and mental disorders are scarce. Because of that, this study wants to find out if humor trainings for people with mental disorders are also as effective as for people without mental disorders or if there are any reasons that restrain the effectivity of the training.

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Organizational Data

  •   DRKS00012443
  •   2017/05/16
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  •   yes
  •   Approved
  •   EK-GZ:44/2016, Ethikkommission der Paris-Lodron-Universität Salzburg
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Secondary IDs

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Health Condition or Problem studied

  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
  •   F33.0 -  Recurrent depressive disorder, current episode mild
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F34.1 -  Dysthymia
  •   F40 -  Phobic anxiety disorders
  •   F42 -  Obsessive-compulsive disorder
  •   F43.2 -  Adjustment disorders
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Interventions/Observational Groups

  •   Experimental group:
    Seven-weeks humor training. Each of the weekly sessions lasts 90 minutes. Every session deals one specifiic humor topic. In the sessions there are psychoeducational elements and role plays/exercises/plays to practice and deepen the learned topics. The experimental group is randmoized and receives the humor training right after the assignment to the group.
  •   Wait-list control group:
    This group is also randomized and receives the humor training after the experimental group participated and evaluation measures have been completed. Evaluation meausres are filled in simultaneously to the experimental group: 1 week before the start of the experimental group's training, 1 week after the completion of the training and 1 month after the completion of the training. After follow-up measures are completed, the wait-list control group receives the humor training which is the same as the training the experimental group received.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   I-II
  •   N/A
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Primary Outcome

Coping Humor Scale (CHS):
3 measurement points: Pre, post and follow-up (after 1 month) --> filled in online

State-Trait-Cheerfulness-Inventory (STCI):
3 measurement points: Pre, post and follow-up (after 1 month) --> filled in online

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Secondary Outcome

StateTrait-Anxiety-Inventory (STAI):
3 measurement points: Pre, post and follow-up (after 1 month) --> filled in online

WHO 5 Well-being-Index (WHO-5):
3 measurement points: Pre, post and follow-up (after 1 month) --> filled in online

Center for Epidemiological Studies-Depression scale (CES-D):
3 measurement points: Pre, post and follow-up (after 1 month) --> filled in online

Gelotophobia questionnaire (GELOPH-15):
3 measurement points: Pre, post and follow-up (after 1 month) --> filled in online

Feedback questionnaire (self generated):
1 measurement point at post

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/03/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

good German language skills, no cognitive deficits and diagnoses F32.0 + F32.1, F33.0 + 33.1, F34.1, F40, F42, F43.2

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Exclusion Criteria

Exclusion criteria are:
-F20-29 Schizophrenia and schizoaffective/delusional disorders
-F30 manic episode
-F31 bipolar disorder
-F32.2/F32.2 severe depression with/without psychotic symptoms
-F33.2/F33.3 recurrent severe depression with/without psychotic symptoms
-F43.0/F43.1 acute stress reaction/ PTSD
-F44 dissociative disorders
-F50 eating disorders
-F60-69 personality disorders

-acute suicidality
-age <18 or >80
-cognitive deficits
-no German language skills

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Addresses

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    • Universität Salzburg
    • Hellbrunner Straße 34
    • 5020  Salzburg
    • Austria
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    • Universität Salzburg
    • Ms.  MSc  Nektaria  Tagalidou 
    • Hellbrunner Straße 34
    • 5020  Salzburg
    • Austria
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    • Universität Salzburg
    • Ms.  MSc  Nektaria  Tagalidou 
    • Hellbrunner Straße 34
    • 5020  Salzburg
    • Austria
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Sources of Monetary or Material Support

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    • Universität Salzburg
    • Hellbrunner Straße 34
    • 5020  Salzburg
    • Austria
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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