Improve Mental HealthNCT01414218
The Impact of a Humor Seminar on General Well Being, Quality of Life and Psychological Distress Among Community Dwelling Elders
A study testing Humor as a Way of Life Seminar in people with Improve Mental Health, run by Happy Nation Society.
Trial summary
1. Senior citizens living in the community who participate in a humor seminar will have improved health quality of life compared to those not participating in the seminar. 2. Senior citizens living in the community who participate in a humor seminar will have improved general well being compared to those not… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Improve Mental Health
- What is being tested?
- Humor as a Way of Life Seminar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- attendance at a community senior center
- ability to read and write hebrew or English
Who cannot join
- Not cognitively impaired
About this study
Official title: Influence of Humor as a Way of Life on Well Being, Quality of Life and Immune Function
- Senior citizens living in the community who participate in a humor seminar will have improved health quality of life compared to those not participating in the seminar.
- Senior citizens living in the community who participate in a humor seminar will have improved general well being compared to those not participating in the seminar
- Senior citizens living in the community who participate in a humor seminar will have decreased psychological distress compared to those not participating in the seminar
Read the detailed description
Participants for this study will be chosen from senior centers . All members of the senior centers who can read and write either Hebrew or English and are not cognitively impaired (as assessed by the administrator/social worker in charge of the center) will be asked to participate. It is estimated that between 30-50 members of each senior center will agree to participate. The control group will be chosen by convenience sampling of members from other, different senior centers. These centers will be chosen based on close geographic proximity and similar demographic characteristics to the experimental, humor group, senior centers. The choice of which center will be used for the experimental and control groups will be based on logistic considerations.
This method of sample selection and group assignment were chosen due to several considerations. At present there are approximately 60 participants in the Rishon Lezion Holocaust survivor senior center. It is highly unlikely that all of the members of the center will agree to participate in the study and/or will continue with the entire intervention. Based on a power of .80 and an alpha rate of .05, in order to detect a significant difference between two groups with a moderate effect size, a total of 64 subjects will be necessary for each of the two groups, the experimental and the control each group. Therefore, there are not enough seniors in one center to participate in either groups and additional sites for subject recruitment was found to be necessary.
A second consideration is diffusion of the treatment protocol. It is thought that if both the control and humor groups were recruited from the same senior center, then there would be the possibility that the seniors would discuss among themselves the humor intervention, thereby leading to a diffusion of treatment. In this situation, it might be hard to differentiate between those who participated in the humor and the control group. Therefore, the seniors of the control group would need to be recruited from another senior center.
This process then leads to another issue, namely selection bias, in that the control and humor groups might be different from the outset of the study. Two measures will be taken to decrease this threat to the internal validity of the study. Firstly, an attempt will be made to match the senior centers that will be used to recruit those in the control group with the senior centers used for the humor group, based on geographic location and demographic characteristics. Secondly, both the control and humor groups will be asked to complete the questionnaires at the beginning and at the end of the study. Therefore, differences will be determined between the two groups at two points in time.
Humor Program: The "Humor as a Way of Life" program will be comprised of one session per week lasting 2-3 hours per session. The program will take six months to complete. The first three months of the program will be moderated by Mr. Yochanan Waller, a known video producer and humorist. Under Mr Waller's direction, each participant will be requested to relate a humorous story or situation. These sessions will be video recorded. Between each session, Mr Waller will edit each session. At the next session, all of the participants will view all of the stories related during the previous session. Any parts of the videos that are not used for the purpose of the program will be destroyed.
The first four weeks of the program will include strategies to incorporate humor into everyday life. These sessions will be conducted by Mr. Enzo Agada, a known humorist, and his wife, Amalia Garbulsky, a Social Worker. The topic of humor and its impact on everyday life will be presented and discussed. Initially the moderator will tell humorous stories and aim to trigger reactions or comments from the participants about their own personal associations of what they just heard. Participants will be asked about humorous life events and will be asked to share those events with the group. During each session the moderators will generate an atmosphere of mirth and will try to involve as many participants as possible in the discussion. The moderator will act as a stimulant for humor, smiling, and laughter.
At the end of the four months, a large celebration will be conducted where a final video will be shown that summarizes the project.
During the next two months, volunteers will be recruited to transport the participants to other senior centers in groups of 3-4. The participants will share with the seniors the final video and will try and encourage other seniors to use humor in their daily lives.
Instruments: Four questionnaires will be used in this study; a demographic data questionnaire, the RAND Health Survey (Hays, Sherbourne, \& Mazel, 1993), the General Well Being Schedule (Dupuy, 1987)and the Brief Symptom Inventory (Derogatis \& Spencer, 1982).
After institutional ethical review and approval, each potential senior center administrator will be contacted to gain approval for admission to the site to collect data. The principle investigator of the study will oversee and supervise all data collection. All members of each senior center who speak and write Hebrew or English and are cognitively competent (as assessed by the administrator/social worker of each senior center) will be asked to participate. These seniors will be contacted, the study will be described and informed consent obtained. Copies of the informed consent form will be given to each participant. After informed consent was obtained, each participant will fill out the three questionnaires. Data collectors will be available to help participants fill out their forms if necessary. This data collection will take place before the project has begun. Each participant will be asked to write the last four digits of their identity numbers on the form so that follow up questionnaires will be able to be correlated with baseline data. All subjects will fill out all forms at baseline and after six months, after completion of the project. Control subjects will be offered the option of participating in the next humor therapy session whenever possible.
If the results of the GWB questionnaire indicate great psychological distress of the participant, then the administrator/social worker of the senior center will be informed as necessary.
Analysis: Descriptive statistics will be used to describe the sample and results of the RAND and GWB questionnaires. Differences between the two groups will be determined using a MANOVA.
- Conditions
- Improve Mental Health
- Being tested
- Humor as a Way of Life Seminar
- Keywords
- elderly, humor, general well being, psychological distress, health quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humor as a Way of Life SeminarBehavioural
One session per week lasting 2-3 hours per session for 4 months. Sessions will include the videotaping of humorous stories or situations and instruction related to strategies to incorporate humor into everyday life.
| Study group | Role | What they receive |
|---|---|---|
| Humor as Way of Life Seminar | Experimental | See description of study in previous section for further details. Receives: Behavioral: Humor as a Way of Life Seminar |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Well Being
General Well Being as measured by the General Well Being Scale
Measured: after 6 months
Psychological Distress
Psychological distress as measured by the Brief Symptom Inventory
Measured: after 6 months
Health Quality of Life
Health Quality of Life as measured by the Rand Health Survey
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improve Mental HealthStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happy Nation Society
- Sponsor type
- University, hospital or other
- Investigators
- Freda Dekeyser Ganz, PhD, Principal investigator, Hadassah Hebrew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414218
- Sponsor's protocol ID
- humor1
- Status last verified
- Aug 2011
- First submitted
- 4 Aug 2011
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Humor as a Way of Life on Well Being, Quality of Life and Immune Function
- ClinicalTrials.gov ID
- NCT01414218
- Acronym / sponsor ID
- humor1
- Conditions
- Improve Mental Health
- Keywords
- elderly, humor, general well being, psychological distress, health quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Happy Nation SocietyUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Aug 2011 (estimated)
- 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.
- Senior citizens living in the community who participate in a humor seminar will have improved health quality of life compared to those not participating in the seminar.
- Senior citizens living in the community who participate in a humor seminar will have improved general well being compared to those not participating in the seminar
- Senior citizens living in the community who participate in a humor seminar will have decreased psychological distress compared to those not participating in the seminar
Detailed description
Participants for this study will be chosen from senior centers . All members of the senior centers who can read and write either Hebrew or English and are not cognitively impaired (as assessed by the administrator/social worker in charge of the center) will be asked to participate. It is estimated that between 30-50 members of each senior center will agree to participate. The control group will be chosen by convenience sampling of members from other, different senior centers. These centers will be chosen based on close geographic proximity and similar demographic characteristics to the experimental, humor group, senior centers. The choice of which center will be used for the experimental and control groups will be based on logistic considerations.
This method of sample selection and group assignment were chosen due to several considerations. At present there are approximately 60 participants in the Rishon Lezion Holocaust survivor senior center. It is highly unlikely that all of the members of the center will agree to participate in the study and/or will continue with the entire intervention. Based on a power of .80 and an alpha rate of .05, in order to detect a significant difference between two groups with a moderate effect size, a total of 64 subjects will be necessary for each of the two groups, the experimental and the control each group. Therefore, there are not enough seniors in one center to participate in either groups and additional sites for subject recruitment was found to be necessary.
A second consideration is diffusion of the treatment protocol. It is thought that if both the control and humor groups were recruited from the same senior center, then there would be the possibility that the seniors would discuss among themselves the humor intervention, thereby leading to a diffusion of treatment. In this situation, it might be hard to differentiate between those who participated in the humor and the control group. Therefore, the seniors of the control group would need to be recruited from another senior center.
This process then leads to another issue, namely selection bias, in that the control and humor groups might be different from the outset of the study. Two measures will be taken to decrease this threat to the internal validity of the study. Firstly, an attempt will be made to match the senior centers that will be used to recruit those in the control group with the senior centers used for the humor group, based on geographic location and demographic characteristics. Secondly, both the control and humor groups will be asked to complete the questionnaires at the beginning and at the end of the study. Therefore, differences will be determined between the two groups at two points in time.
Humor Program: The "Humor as a Way of Life" program will be comprised of one session per week lasting 2-3 hours per session. The program will take six months to complete. The first three months of the program will be moderated by Mr. Yochanan Waller, a known video producer and humorist. Under Mr Waller's direction, each participant will be requested to relate a humorous story or situation. These sessions will be video recorded. Between each session, Mr Waller will edit each session. At the next session, all of the participants will view all of the stories related during the previous session. Any parts of the videos that are not used for the purpose of the program will be destroyed.
The first four weeks of the program will include strategies to incorporate humor into everyday life. These sessions will be conducted by Mr. Enzo Agada, a known humorist, and his wife, Amalia Garbulsky, a Social Worker. The topic of humor and its impact on everyday life will be presented and discussed. Initially the moderator will tell humorous stories and aim to trigger reactions or comments from the participants about their own personal associations of what they just heard. Participants will be asked about humorous life events and will be asked to share those events with the group. During each session the moderators will generate an atmosphere of mirth and will try to involve as many participants as possible in the discussion. The moderator will act as a stimulant for humor, smiling, and laughter.
At the end of the four months, a large celebration will be conducted where a final video will be shown that summarizes the project.
During the next two months, volunteers will be recruited to transport the participants to other senior centers in groups of 3-4. The participants will share with the seniors the final video and will try and encourage other seniors to use humor in their daily lives.
Instruments: Four questionnaires will be used in this study; a demographic data questionnaire, the RAND Health Survey (Hays, Sherbourne, \& Mazel, 1993), the General Well Being Schedule (Dupuy, 1987)and the Brief Symptom Inventory (Derogatis \& Spencer, 1982).
After institutional ethical review and approval, each potential senior center administrator will be contacted to gain approval for admission to the site to collect data. The principle investigator of the study will oversee and supervise all data collection. All members of each senior center who speak and write Hebrew or English and are cognitively competent (as assessed by the administrator/social worker of each senior center) will be asked to participate. These seniors will be contacted, the study will be described and informed consent obtained. Copies of the informed consent form will be given to each participant. After informed consent was obtained, each participant will fill out the three questionnaires. Data collectors will be available to help participants fill out their forms if necessary. This data collection will take place before the project has begun. Each participant will be asked to write the last four digits of their identity numbers on the form so that follow up questionnaires will be able to be correlated with baseline data. All subjects will fill out all forms at baseline and after six months, after completion of the project. Control subjects will be offered the option of participating in the next humor therapy session whenever possible.
If the results of the GWB questionnaire indicate great psychological distress of the participant, then the administrator/social worker of the senior center will be informed as necessary.
Analysis: Descriptive statistics will be used to describe the sample and results of the RAND and GWB questionnaires. Differences between the two groups will be determined using a MANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Humor as Way of Life Seminar | Experimental | Behavioral: Humor as a Way of Life SeminarSee description of study in previous section for further details. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- attendance at a community senior center
- ability to read and write hebrew or English
Key exclusion criteria (1 listed)
- Not cognitively impaired
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 |
|---|---|---|
| Humor as a Way of Life SeminarOne session per week lasting 2-3 hours per session for 4 months. Sessions will include the videotaping of humorous stories or situations and instruction related to strategies to incorporate humor into everyday life. | Behavioural | Humor as Way of Life Seminar |
Primary outcome
General Well Being
Time frame: after 6 months
General Well Being as measured by the General Well Being Scale
Psychological Distress
Time frame: after 6 months
Psychological distress as measured by the Brief Symptom Inventory
Health Quality of Life
Time frame: after 6 months
Health Quality of Life as measured by the Rand Health Survey
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 11 Aug 2011.
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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.
Freda Dekeyser Ganz, PhD principal investigator
Hadassah Hebrew University
Questions about this trial
What is this clinical trial studying?
A study testing Humor as a Way of Life Seminar in people with Improve Mental Health, run by Happy Nation Society.
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 2 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 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
General Well Being (time frame: after 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2011.