UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of spiritual reminiscence therapy on elderly
Acronym	spiritual reminiscence therapy and elderly
Scientific Title	The Effect of spiritual reminiscence therapy on Depression and hope in life in the elderly
Scientific Title:Acronym	Effect of spiritual reminiscence therapy on Depression and hope in life
Region	Asia(except Japan)

Condition
Condition	Patients are selected on the basis of include and exclude criteria and after obtaining informed consent, four randomly assigned quadruple blocks are assigned to two groups B and A. For this method, with the Statistical counselor assistance , a table consist of 156 letters B and A is provided, and then each of these letters is enclosed in a sealed envelope to hide Random assignment, then closing each envelope. It will be numbered in order of the original table. After choosing the appropriated elder, the envelope is opened to the elder and according to the inside letter, the person is assigned to each groups.
Classification by specialty	Psychiatry Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	determine of spiritual reminiscence therapy on Depression and hope in life in the elderly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Depression hope in life
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: In this group, after completing demographic form, depression questionnaires (GDS) and Schneider's hop of life questionnaire, spiritual reminiscence therapy will be done in 6 week sessions for 60 to 90 minutes. After the end of sessions, questionnaires will be completed again.
Interventions/Control_2	Control group: Only demographic form, depression questionnaire (GDS) and Schneider's hop of life questionnaire will be completed before and after the intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	60 years-old <
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	60-80 years, cognitive health function assessed by the (BACT) Cognitive Screening Tool , verbal communication ability , no addiction to alcohol and drugs.
Key exclusion criteria	Acute illness and hospitalization and absence in more than one session of six sessions of spiritual reminiscence therapy
Target sample size	156

Research contact person
Name of lead principal investigator	1st name Ali Middle name Last name Abbasi
Organization	Shahroud University of Medical Sciences
Division name	School of Nursing and Midwifery
Zip code	36147-73947
Address	7th Sq, Shahroud, Iran.
TEL	00982332393811
Email	abbsi_msn@yahoo.com

Public contact
Name of contact person	1st name Ali Middle name Last name Abbasi
Organization	Shahroud University of Medical Sciences
Division name	School of Nursing and Midwifery
Zip code	36147-73947
Address	7th Sq, Shahroud, Iran.
TEL	00982332393811
Homepage URL	http://shmu.ac.ir/fa
Email	abbsi_msn@yahoo.com

Sponsor
Institute	Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences
Institute
Department

Funding Source
Organization	Department of Nursing, School of Nursing and Midwifery, Shahroud University of Medical Sciences
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shahroud University of Medical Sciences
Address	7th Sq, Shahroud, Iran.
Tel	0098 23 32393811
Email	abbsi_msn@yahoo.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date	2020 Year 02 Month 15 Day
Last follow-up date	2020 Year 06 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 02 Day
Last modified on	2020 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044860