Comparison of the Effectiveness of Humor Therapy and Cognitive Rehabilitation on Agitation, Apathy, Cognitive and Memory Function in Patients with Mild Cognitive Impairment (MCI)
Determining the effectiveness of humor therapy on Agitation, Apathy, Cognitive and Memory Function in Patients with (MCI)and comparing it with the effectiveness of cognitive rehabilitation
Design
Clinical trial with control group, with parallel groups, randomized, on 45 patients, simple random
Settings and conduct
This study is conducted at Kahrizak Institute in Alborz Province.
Participants/Inclusion and exclusion criteria
Seniors over 65 years of age
Entry criteria: elderly resident with MCI, ability to speak
Non-entry criteria: No psychiatric medications, no hearing problems
Intervention groups
Cognitive Rehabilitation Intervention: Cognitive Rehabilitation Guide includes strategies and techniques. Compiled at Trinity College Dublin and the Alzheimer's Society of Ireland by Kelly and O'Sullivan (2015).
Humor Therapy Intervention: Seven Humor Skills designed by McGhee (2004).
A control group that does not receive any intervention during the study process. Only pre-tests and post-tests will be taken from them.
Main outcome variables
Apathy; Agitation; cognitive and Memory Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201012049009N1
Registration date:2020-12-10, 1399/09/20
Registration timing:retrospective
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Zahra Fereidouni Valashejerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3443 1030
Email address
zfereidouni@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
2020-09-22, 1399/07/01
Actual recruitment end date
2020-09-22, 1399/07/01
Trial completion date
2020-09-26, 1399/07/05
Scientific title
Comparison of the Effectiveness of Humor Therapy and Cognitive Rehabilitation on Agitation, Apathy, Cognitive and Memory Function in Patients with Mild Cognitive Impairment (MCI)
Public title
The effect of humor therapy and cognitive rehabilitation on mild cognitive impairment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
elderly residents home
mild cognitive impairment
The ability to speak
Exclusion criteria:
No psychiatric medications
No hearing problems
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process is performed www.randomization.com the site. In order to hide random allocation, random sequence sealed envelope is used. In this way, the sample size of 45 people, the envelope is prepared by the reception officer of the center and each of the random sequences created on a card is recorded and the cards are placed in the envelopes in order, in order to maintain the random sequence, the numbering is done on the external surface of the envelopes in the same order. Based on the order of entry of eligible participants into the study, one of the envelopes is opened and the assigned group of the participant is revealed and during this time the researcher and participants are not aware of the allocation of the experimental and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Tonekabon
Street address
No. 98, Valfajr 4, Pirouzi Alley, Motahari St.
City
Karaj
Province
Alborz
Postal code
3143877766
Approval date
2020-11-19, 1399/08/29
Ethics committee reference number
IR.IAU.TON.REC.1399.050
Health conditions studied
1
Description of health condition studied
Mild Cognitive Impairment (MCI)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total number less than 24 in Montreal Cognitive Assessment-Basic (MoCA-Basic)
Timepoint
Before the intervention, after the intervention, two months after the intervention
Method of measurement
Total score in Montreal Cognitive Assessment-Basic (MoCA-Basic),
2
Description
Total score in Cohen-Mansfield Agitation Inventory
Timepoint
Before the intervention, after the intervention, two months after the intervention
Method of measurement
Total score in Cohen-Mansfield Agitation Inventory
3
Description
Total score in apathy Martin's inventory
Timepoint
Before the intervention, after the intervention, two months after the intervention
Method of measurement
Total score in apathy Martin's inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Stages of humor training Educational content relied on the seven steps of fostering Paul McGui's sense of humor (2004). The program includes the effect of humor on life, examining the sense of humor of the members of the group from their point of view, theories about humor and discussion of ways of enhancing the spirit of humor, teaching humor skills, practicing jokes, benefits and types of humor, exposure to resistances and direct guidelines on how to use humor in the living environment and in times of crisis. At the end of each session, assignments were determined and each session started with discussions about the assignments performed.The humor skills training program was divided into meetings: the first session: familiarity with the rules of the group, discussing of learning this skill as a positive defense mechanism and its impact on social interactions and physical health. The humor skills training program was divided into meetings: the first session, familiarity with the rules of the group, discussion of the concept and benefits of humor, the necessity of learning this skill as a positive defense mechanism and its impact on social interactions and physical health. Second session: Identifying the uniqueness of people's humor style, discussion, modeling and behavioral exercises such as funny imaginary dialogue with the other person and practicing it.Session 3: Practicing laughter, using the discussion method, activating the child inside and ten minutes of laughter without reason and expressing feelings. Session 4: The ability to play with words, to say jokes and riddles, to teach specific skills of humor, to use alternative. words as jokes. Session 5: Seeking satirical awares in everyday life, such as taking notes of any funny events among your or others' funny experiences, patterning and and ten minutes of laughing without reason and expressing feelings.Session 6: Learning to laugh at oneself, using the method of drawing your cartoon, laughing at the members together, practicing countering group inhibitions, and ten minutes of laughing without reason and expressing feelings. Session 7: The use of humor at the height of tension and discomfort, discussing the style of humor in stressful and fearful situations, teaching the patterns of humor application in these situations to the people of the group.Session 8: Summing up and exchanging experiences, applying the skills learned during this period and reviewing its effect. A summary of the training program and reviewing its effects on the group members and evaluating the program. Session 9: Post-test stage and re-implementation of questionnaires
Category
Behavior
2
Description
Intervention group: Session 1: Familiarity with group rules, discussion of learning these skills and cognitive rehabilitation exercises as strategies and techniques to improve memory and increase one's recall and its impact on one's daily life, as well as social interactions.Session 2: Teaching the basics about memory and recall, verbal repetition and continuous processing Session 3: Dual cognitive support: illustration and memory enhancement, errorless learning. Session 4: Teaching Recall Strategies: Mnemonics, Cueing. Session 5: Continuation of Recall Strategies Training: Chunking, Loci Method, Spaced Retrieval Session 6: Specific interventions including face-name Recall: face accompaniment of face - names of familiar members of the group through their photographs.Session 7: Story Recall, List/Object Recall.Session 8: Procedural Memory, practice and repetition with the aim of mastering the task.Session 9:Additional Support, Auxiliary programs and techniques including memory aids.Session 10: Adaptation to the individual's living environment, relaxation training.
Category
Behavior
3
Description
Control group: Control group: do not receive any intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak Institute of Alborz Province
Full name of responsible person
Zahra Fereidouni Valashejerdi
Street address
Sahebzaman St., 1st Golestanak St., Mohammad Shahr, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3184885686
Phone
+98 26 3630 9171
Fax
+98 26 3630 9171
Email
karajkahrizak@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Branch of Tonekabon Islamic Azad University
Full name of responsible person
Massoud Ghanee
Street address
Tonekabon Islamic Azad University,km 3 of Chalous road,Mazandaran,Iran
City
Tonekabon
Province
Mazandaran
Postal code
4684161167
Phone
+98 11 5427 1510
Fax
+98 11 5427 1510
Email
masoodghane@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Branch of Tonekabon Islamic Azad University