Protocol summary

Study aim
The effectiveness of group reality therapy on anxiety and depression of family caregivers of the elderly with multiple chronic conditions
Design
Randomized controlled trial with pre and post-test design, with two experimental and control groups, without blinding, the allocation of family caregivers in two experimental (reality therapy) and control groups (without intervention) is done by block random assignment method.
Settings and conduct
Two health centers and outpatient clinics of three government hospitals are the sampling sites. After obtaining informed and written consent from eligible samples, family caregivers are divided into experimental (A: implementation of reality therapy intervention) and control groups (B: without intervention) using block random allocation method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Caring for an elderly family member with multiple chronic illnesses for at least three months, Age 18-60 years Exclusion criteria: Participate in any other related research on geriatric care over the past two years, Inability to take care of oneself and perform daily activities
Intervention groups
Reality therapy is implemented for the experimental group; While no intervention is carried out for the control group. After completing the intervention in the the experimental group and and collecting the questionnaires in both groups, in order to observe moral considerations, the reality therapy package will be provided to the control group. The researcher devised the content of this intervention based on choice theory and based on reality therapy techniques and Dr. William Glasser's reality therapy book translated by Dr. Ali Sahebi, reviewing the studies of reality therapy and under the supervision of a doctor of psychology.
Main outcome variables
Anxiety Depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210920052525N1
Registration date: 2021-10-23, 1400/08/01
Registration timing: registered_while_recruiting

Last update: 2021-10-23, 1400/08/01
Update count: 0
Registration date
2021-10-23, 1400/08/01
Registrant information
Name
Sahar Malmir
Name of organization / entity
Nursing Department, Faculty of Medical Science, Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 66 3330 9193
Email address
s.maleh@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2021-10-30, 1400/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Group Reality Therapy on Anxiety and Depression of Iranian Family Caregivers of the Elderly with Multiple Chronic Conditions: A Randomized Controlled Trial Study
Public title
The Effectiveness of Group Reality Therapy on Anxiety and Depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Caring for an elderly family member with multiple chronic illnesses for at least three months Age 18-60 years Willingness to participate in the study Having literacy Being able to communicate and use a smartphone
Exclusion criteria:
Participate in any other related research on geriatric care over the past two years Inability to take care of oneself and perform daily activities Having a severe mental disorder that requires medication
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Step 1: Random sequence generation: Considering that the researchers of this study tend to have all sample groups with equal sample size, they used restricted randomization. In the present study, the method used in this type of randomization in order to create a balance in the number of samples assigned to each of the studied groups is block randomization. The placement of family caregivers of the elderly with several chronic diseases in two groups of intervention (reality therapy) and control (without intervention) was done by block random allocation method. The method of assigning 50 eligible samples to two groups of 25 is as follows: the method of 4 random blocks is used to assign family caregivers to the four groups studied. To do this, first write a list of blocks and assign numbers to them {(1) AABB- (2) ABAB- (3) ABBA- (4) BBAA- (5) BABA- (6) BAAB}. Then, using a table of random numbers, 13 random numbers between 1 to 6 are created and according to the mentioned numbers, the relevant block is selected and a random sequence is formed as a sequence of letters A and B (letter A for the test group and letter B for the control group). Step 2: Concealment of random allocation: To perform a random sequence on the study participants, Sequentially numbered, sealed, opaque envelopes are used. In such a way that the assigned group is not specified before the individual is assigned; A number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface of the envelopes. Finally, the lids of the letter envelopes are glued and placed inside the boxes, respectively. At the beginning of the registration of participants, one of the envelopes of the letter is opened and the assigned group of the participant is revealed, according to the order of entry of the eligible participants. Step 3: Execute the random allocation process: The student examines the participants in terms of inclusion and exclusion criteria in the study and registers them in the study. However, the person who assigns the participants to the groups will not be involved in the intervention and data collection of the participants.
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 Committees of Tarbiat Modares University
Street address
Tehran, Jalal AleAhmad, Nasr,Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.MODARES.REC.1398.045

Health conditions studied

1

Description of health condition studied
Multiple Chronic Conditions
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention and after intervention (End of a month)
Method of measurement
Depression, Anxiety and Stress Questionnaire (DASS-21)

2

Description
Depression
Timepoint
Before intervention and after intervention (End of a month)
Method of measurement
Depression, Anxiety and Stress Questionnaire (DASS-21)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Reality therapy intervention is done for a period of one month in the form of group training and twice a week. The sessions are conducted by the researcher (PhD student in nursing) and PhD in psychology on family caregivers in the intervention group with the aim of reducing their anxiety and depression. Topics of 8 sessions of reality therapy include "environment and assessment; providing information and flipping; explaining and understanding anxiety based on choice theory and reality therapy; familiarity with depression based on choice theory and the sacrifice triangle; communication skills training as a deterrent External control and its destructive effects mean anxiety and depression; communication skills (internal control and general behavior machine); intelligent planning (SMART PLAN); WDEP process to solve the problem.
Category
Other

2

Description
Control group: They do not receive any intervention and only receives health and medical care that is specific to the elderly from medical centers or health centers. These cares include: health advice about caring for the chronic diseases of the elderly, how to take medication, medical visits.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Out patient of Ashayer hospital
Full name of responsible person
Babak Hadian
Street address
Lorestan, Khorramabad, Enghelab Street, Ashayer hospital
City
khorramabad
Province
Lorestan
Postal code
68169 33132
Phone
+98 66 3323 6402
Fax
Email
shohadahospital@lums.ac.ir

2

Recruitment center
Name of recruitment center
Outpatient clinic of Shahid Madani Hospital
Full name of responsible person
Babak Abdolkarimi
Street address
Lorestan, Khorramabad, Imam Hossein Square, Shahid Beheshti St. (Khairabad), Shahid Ayatollah Madani Hospital
City
Khorramabad
Province
Lorestan
Postal code
6814713115
Phone
+98 66 3341 9123
Email
madanihospital@lums.ac.ir

3

Recruitment center
Name of recruitment center
Shahid Rahimi Hospital Outpatient Clinic
Full name of responsible person
Saeed Rahimi
Street address
Lorestan, Khorramabad, Azadi Square, Mojahedin St., not far from Safavid Bridge, Shahid Seyed Fakhreddin Rahimi Hospital
City
Khorramabad
Province
Lorestan
Postal code
6813816314
Phone
+98 66 3333 6143
Email
rahimihospital@lums.ac.ir

4

Recruitment center
Name of recruitment center
Urban Health Center
Full name of responsible person
Ramin Khosravifar
Street address
East Goldasht, Karim Khan Zand Square
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3343 7794
Email
publicrelation@lums.ac.ir

5

Recruitment center
Name of recruitment center
Health Unit
Full name of responsible person
Mehrdad Hosseinpour
Street address
Not reached Imam Hossein Square, Patio Gol Alley, Shaghayegh
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3340 8786
Email
m.h.khorramabad @lums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaghoub Fathollahi
Street address
Tehran, Jalal Al-Ahmad, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Email
fatolahi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares 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
Tarbiat Modares University
Full name of responsible person
Sahar Malmir
Position
Phd Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alavi Street
City
Khorramabad
Province
Lorestan
Postal code
6813963658
Phone
+98 66 3330 9193
Email
saharmalmir93@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Hassan Navipour
Position
Assistant Professor of Nursing Management
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Jalal Al-Ahmad, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 6657 0089
Email
naviporh@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sahar Malmir
Position
Phd Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alavi Street
City
Khorramabad
Province
Lorestan
Postal code
6813963658
Phone
+98 66 3330 9193
Email
saharmalmir93@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data obtained in relation to the target population of this study are related to demographic information and the two main outcomes of the study, namely anxiety and depression, which are reported anonymously and as a result of the analysis of the findings.
When the data will become available and for how long
Access period starts from 1401
To whom data/document is available
Researchers in the field of nursing and psychology All health care providers Nursing politicians
Under which criteria data/document could be used
Reference to the researchers of this study
From where data/document is obtainable
Send a message to saharmalmir93@gmail.com
What processes are involved for a request to access data/document
Data is sent after obtaining permission from the supervisors
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