Protocol summary

Study aim
Comparing the Effectiveness of Spirituality Therapy and Acceptance and Commitment therapy on Sleep Quality, Resilience and Death Anxiety in the Elderly
Design
A randomized controlled clinical trial with parallel groups, Randomized block, sample size 45 (15 persons per group)
Settings and conduct
Before starting the sessions and obtaining permission, all three groups completed questionnaires of resilience, anxiety, and sleep quality. Experimental group A (spirituality therapy) and experimental group B (acceptance and commitment therapy) were trained weekly in the nursing home for the elderly men and women. The control group received no intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria were: having at least 60 years of age, having at least secondary education, not receiving psychological treatment since diagnosis. Exclusion criteria include acute or chronic medical illnesses such as epilepsy, skeletal diseases, heart and respiratory failure, etc. which can cause long-term problems, severe mental illnesses such as psychotic disorders, psychotropic medications or abuse in present.
Intervention groups
For the first group spirituality therapy, for the second group acceptance and commitment therapy, and in the third group no intervention will be performed.
Main outcome variables
Sleep Quality; Resilience; Death Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200210046450N1
Registration date: 2020-04-06, 1399/01/18
Registration timing: registered_while_recruiting

Last update: 2020-04-06, 1399/01/18
Update count: 0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Bahman Hajatnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4686 4886
Email address
b.hajatnia@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-15, 1398/09/24
Expected recruitment end date
2020-05-10, 1399/02/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Spirituality Therapy and Acceptance and Commitment therapy on Sleep Quality, Resilience and Death Anxiety in the Elderly
Public title
Comparing the Effectiveness of Spirituality Therapy and Acceptance and Commitment therapy on Sleep Quality, Resilience and Death Anxiety in the Elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 60 Minimum high school education Lack of psychological treatment since diagnosis
Exclusion criteria:
Acute or chronic medical illnesses such as epilepsy, skeletal diseases, heart and respiratory failure, etc. which can cause problems in long sessions. severe mental illness such as psychotic disorders psychotropic drugs or substance abuse at present
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is performed by the statistical consultant as follows: randomization is performed in three groups: Spirituality Therapy, Acceptance and Commitment therapy, and control: First, a list of eligible individuals is provided and coded. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows: A = Spirituality Therapy, B = Acceptance and Commitment therapy, and C control group In this study with three groups A, B and C we create the following six groups and assign 1 to 6 each: ABC-ACB-BAC-BCA-CAB-CBA Then, using the random number table, we choose one of these blocks whenever the numbers 1, 2, 3, 4, 5, 6 appear, and if the other number appears, consider null and go to the next choice. . In fact, we have obtained a random sequence of numbers with a random number table that we consider the order of assignment for each number. This way the number of people in the groups will be approximately equal.
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 Hormozgan University Of Medical Sciences
Street address
No. 64, Janbazan Ave., North Karegar Street
City
Tehran
Province
Tehran
Postal code
1437697419
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.339

Health conditions studied

1

Description of health condition studied
Elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Resiliency
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Connor-Davidson Resiliency Questionnaire

2

Description
Death Anxiety
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Cult-Leicester Death Anxiety Scale

3

Description
Sleep Quality
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the present study, the purpose of group spirituality therapy is 8 sessions based on Ahmadi et al. (2014) spiritual therapy intervention, which was held two sessions per week (for one month) and each session for 90 minutes.
Category
Treatment - Other

2

Description
Intervention group II: Acceptance and commitment therapy and a 90-minute 9-session treatment plan twice a week (for a month and a half) based on ACT Hayes (2004) protocol and designed as a group experimental group subjects are provided.
Category
Treatment - Other

3

Description
Control group: No Intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz nursing home
Full name of responsible person
Bahman Hajatnia
Street address
No. 61, 24th Ave., Janbazan Street, South Kurdistan Highway.
City
Tehran
Province
Tehran
Postal code
2246578941
Phone
+98 21 2288 1908
Email
b.hajatnia@iaukishint.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Roosta
Street address
Kish Island, Sana'i Boulevard, Free Zone Organization Square, Islamic Azad University of Kish International Branch.
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Email
Info@Iaukishint.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Bahman Hajatnia
Position
Reasearch expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 44, Marvdasht Ave., Police Blvd
City
Shiraz
Province
Fars
Postal code
7941775883
Phone
+98 71 4686 4886
Fax
Email
bahmanhajatnia48@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Bahman Hajatnia
Position
Reasearch expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 44, Marvdasht Ave., Police Blvd
City
Shiraz
Province
Fars
Postal code
7941775883
Phone
+98 71 4686 4886
Fax
Email
bahmanhajatnia48@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Bahman Hajatnia
Position
Reasearch expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 44, Marvdasht Ave., Police Blvd
City
Shiraz
Province
Fars
Postal code
7941775883
Phone
+98 71 4686 4886
Fax
Email
bahmanhajatnia48@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any type of analysis on the data delivered is permitted
From where data/document is obtainable
Bahman Hajatnia Before the Shiraz Marvdasht Road Police after the Faculty of Pharmacy postal code: 7941775883 Tel: +98 71 4686 4886
What processes are involved for a request to access data/document
The request will be sent by email to: b.hajatnia@iaukishint.ac.ir
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