Protocol summary
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Study aim
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the Effect of Group play Therapy on Depression and Loneliness in the Elderly
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Design
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This study was a clinical trial study. The population of this study was 60 elderly patients aged 60 years and older who were referred to Daneshamooz and Sadaf health centers in Mashhad. Individuals based on the goal will be included in the study, then Then randomly and based on the Random numbers Divided In both intervention and control groups. Pre-test is done in both groups
then play therapy sessions are conducted in the intervention group in 12 sessions.
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Settings and conduct
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two health centers that named Daneshamooz and Sadaf
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age 60 and above; willingness to participate in the study; ability to communicate with the researcher; Obtaining a score of at least 7 from a short-cognitive questionnaire; lack of visual and hearing impairment; non-use of antidepressants during the study; absence of acute and chronic disabling diseases and lack of mental disorders; minimal depression ; feeling lonely.
Exclusion criteria: Refuse to participate in the study and collaborate with the researcher; Missing more than 3 sessions at meetings; The deaths of research units; Acute illness or hospitalization during the study.
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Intervention groups
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The subjects were randomly assigned to control and intervention groups. Pre-test is done in both groups, Then the play therapy sessions in the intervention group are 12 sessions and 2 sessions per hour each week. members are organized in groups and groups of 10 people.The control group uses the central service (Organizing Senior Education Classes; Domestic doctor and general practitioner visits; Perform periodic laboratory test; Perform specialist Psychological actions and so on) of the center. After the end of the intervention, post-test is done in both groups.
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Main outcome variables
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Depression
Loneliness
General information
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Reason for update
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Record the actual date of recruitment date and Trial completion date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170619034650N1
Registration date:
2018-01-02, 1396/10/12
Registration timing:
prospective
Last update:
2020-09-25, 1399/07/04
Update count:
1
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Registration date
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2018-01-02, 1396/10/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-01-05, 1396/10/15
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Expected recruitment end date
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2018-02-15, 1396/11/26
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Actual recruitment start date
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2018-01-05, 1396/10/15
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Actual recruitment end date
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2018-02-15, 1396/11/26
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Trial completion date
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2018-02-15, 1396/11/26
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Scientific title
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The Effect of group play therapy on depression and loneliness among the elderly
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Public title
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The Effect of group play therapy on depression and loneliness among the elderly
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Purpose
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Other
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria:: Age 60 and above; willingness to participate in the study; written consent for participation in the research; ability to communicate with the researcher; Obtaining a score of at least 7 from a short-cognitive questionnaire; lack of visual and hearing impairment to an extent that causes activity impairment; non-use of antidepressants during the study; absence of acute and chronic disabling diseases such as kidney disease, cancer, and insufficiency Heart failure and lack of mental disorders; minimal depression (obtaining a score of at least 5 from the depression scale of the elderly); feeling lonely (obtaining a score of at least 21 from the loneliness scale.
Exclusion criteria:
Exclusion criteria: Refuse to participate in the study and collaborate with the researcher; Missing more than 3 sessions at meetings; The deaths of research units; Acute illness or hospitalization during the study.
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Age
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From 60 years old to 90 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals based on the goal will be included in the study, then Then randomly and based on the Random numbers Divided In both intervention and control groups
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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The games in the study are under the supervision of a game therapist
Ethics committees
1
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Ethics committee
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Approval date
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2017-11-23, 1396/09/02
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Ethics committee reference number
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IR.MUMS.REC.1396.248
Health conditions studied
1
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Description of health condition studied
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loneliness
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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depression
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Depression
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Timepoint
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Before and after the end of the intervention
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Method of measurement
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Geriatric depression scale
2
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Description
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Loneliness
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Timepoint
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Before and after the end of the intervention
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Method of measurement
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Loneliness questionnaire (UCLA ver3)
Secondary outcomes
1
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Description
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social support
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Timepoint
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before and after the intevention
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Method of measurement
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social support scale by kasidi
Intervention groups
1
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Description
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Intervention group: Intervention 1 is as follows: the play therapy sessions in the intervention group are 12 sessions and 2 sessions per hour each week. members are organized in groups and groups of 10 people. The first session is a general introduction and description of the activities, explaining the goals of the research and the duties of each person during the intervention and The next sessions will be based on the scheduled schedule.
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Category
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Lifestyle
2
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Description
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Control group: The control group uses the central service (Organizing Senior Education Classes; Domestic doctor and general practitioner visits routinely and periodically; Perform periodic laboratory test; Perform specialist Psychological actions) of the center. No specific action is taken in this group.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available