UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039368
Receipt number R000044860
Scientific Title The Effect of spiritual reminiscence therapy on Depression and hope in life in the elderly
Date of disclosure of the study information 2020/02/02
Last modified on 2020/02/02 22:10:18

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044860


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name