The effect of dignity therapy on internal stigma, dignity and hope of depressed patients in the inpatient and outpatient departments of 505 Aja Hospital in 1403.
Determining the effect of dignity therapy on the internal stigma, dignity and hope of depressed patients in the inpatient and outpatient departments of Aja 505 Hospital in 1403
Design
This clinical trial will be conducted on 72 patients and in two groups of test and control, in a blinded and randomized manner in 6 blocks of 4
Settings and conduct
This study will be carried out in 505 Aja Hospital. At first, the control group will be included in the study, and then in the test group, the intervention will be carried out in the form of the implementation of the dignity therapy protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, age range from 18 to 60 years old, absence of other mental disorders at the same time as depression, ability to read and write in Farsi, definitive medical diagnosis of depression that has been diagnosed for more than three years and go to hospital 505 on an outpatient basis or for hospitalization.
Exclusion criteria: two sessions of non-attendance at the training sessions, unwillingness to continue cooperation, diagnosis of another mental disorder during the study, lack of cooperation of the patient's family.
Intervention groups
Dignity therapy is a non-pharmacological psychological intervention in which the patient is guided towards the feeling of human and inner dignity with the help of an interview with the therapist and the step-by-step implementation of the dignity therapy protocol. Dignity treatment protocol is in accordance with the wishes and specific needs of patients.
Main outcome variables
Dignity therapy is effective in improving the sense of dignity in patients with depression disorders.
Dignity therapy is effective in improving the quality of life of patients with bipolar disorder.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241008063298N1
Registration date:2025-01-11, 1403/10/22
Registration timing:retrospective
Last update:2025-01-11, 1403/10/22
Update count:0
Registration date
2025-01-11, 1403/10/22
Registrant information
Name
Zahra Tat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3622 2374
Email address
zahratat98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-16, 1403/07/25
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dignity therapy on internal stigma, dignity and hope of depressed patients in the inpatient and outpatient departments of 505 Aja Hospital in 1403.
Public title
The effect of dignity therapy on internal stigma, dignity and hope of depressed patients in the inpatient and outpatient departments of 505 Aja Hospital.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Depressed patients in the inpatient and outpatient departments of 505 Aja Hospital.
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will use the random block method (6 blocks of 4) with the aim of randomizing and allocating samples in two control and intervention groups. Depressed outpatients and inpatients will be randomly selected separately. The intervention group will consist of 60% outpatients and 40% inpatients, and the control group will be the same ratio.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher distributes the questionnaires among the studied samples and the study participants do not know whether they are in the control or intervention group. So the study is a blind one.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Aja University of Medical Sciences
Street address
13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flamak and Zarafshan, Quds town (west), Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2024-10-02, 1403/07/11
Ethics committee reference number
IR.AJAUMS.REC.1403.163
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
Primary outcomes
1
Description
Human dignity measurement questionnaire is a 25-item scale to measure human dignity. This questionnaire will be scored based on a 5-point Likert scale. The score of this questionnaire varies between 25 and 125, and according to the way the questionnaire is expressed, a lower score means more dignity and a higher score means less dignity.
Timepoint
Human dignity is measured at the beginning of the intervention and then 14 days after dignity treatment.
Method of measurement
Human Dignity Questionnaire
2
Description
Internalized Stigma of Mental Illness Index (ISMI) is a 29-item self-report instrument. The answers are in the form of four Likert options from completely agree to completely disagree. The way of scoring the questions is that in the first 4 sub scales, I completely agree with a score of 4, I agree with a score of 3, I disagree with a score of 2, and I completely disagree with a score of 1, and in the last sub scale (resistance to stigma), scoring is reversed. That is, I completely agree with a score of 1, I agree with a score of 2, I disagree with a score of 3, and I completely disagree with a score of 4. Overall, a higher score indicates a more intense internal stigma.
Timepoint
The measurement of Internal Stigma is at the beginning and then 14 days after dignity therapy.
Method of measurement
Internalized Stigma Index of Mental Illness (ISMI)
3
Description
The hope questionnaire of Schneider and colleagues has 12 questions and its purpose is to measure the level of hope in people. This questionnaire is designed for people 15 years old and above. To get the score of the questionnaire, the scores of each question are added together. A higher score indicates a higher life expectancy of the respondent, and a lower score indicates a lower life expectancy.
Timepoint
Hope Measurement is done at the beginning and then 14 days after dignity therapy.
Method of measurement
The Hope Questionnaire of Schneider (ADHS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dignity therapy is a non-pharmacological psychological intervention in which the patient is guided by interviewing the therapist with questions from the Dignity Therapy protocol. The questions of the dignity treatment protocol are in accordance with the specific wishes and needs of patients. These interviews are recorded and edited within 3 to 5 days and become a coherent narrative. Editing includes removing colloquial phrases, correcting the chronological order, removing unnecessary content. Another meeting is arranged to read and correct it, and after the patient approves the final version, a printed version is given to the patient to give to her family or friends.
Category
N/A
2
Description
Control group: The pre-test including the demographic information form, questionnaires of human dignity, internal stigma and hope will be provided to the control group, and after two weeks, the post-test will be administered to the control group. And they are asked to complete the questionnaires mentioned. During this period, the control group will not receive any other intervention, apart from the treatment and routine care of the hospital. Then the data collection for the test group will also be done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
505 Aja Hospital
Full name of responsible person
Vahid Donyavi
Street address
505 Nezaja Hospital, End of Oshan Boulevard, Army Highway, End of Imam Ali (AS) highway (North)
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
info@scanteb.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mosaed Reza
Street address
Army University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
rsc_nurse@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
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
Artesh University of Medical Sciences
Full name of responsible person
Zahra Tat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Army University of Medical Sciences, Etemadzadeh Street, Fatemi Square
City
Tehran
Province
Tehran
Postal code
33883171338
Phone
+98 21 3622 2374
Fax
Email
zahratat98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra Tat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Army University of Medical Sciences, Etemadzadeh Street, Fatemi Square
City
Tehran
Province
Tehran
Postal code
3383171338
Phone
+98 21 3622 2374
Fax
Email
zahratat98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra Tat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fatemi Square, Etemad Street ,Fatemi Square, Etemadzadeh Street, Army University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
3383171338
Phone
+98 21 3622 2374
Fax
Email
zahratat98@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
Just part of the data, such as information related to the main outcome or similar, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
All postgraduate students of medical sciences and researchers and professors of medical sciences universities of the country
From where data/document is obtainable
Adress: Dr. Zahra Farsi- Vice President of Research- Additional Education- Faculty of Nursing- Aja University of Medical Sciences. Contact number: 02177500929 Email address: zahrafarsi@gmail.com
Address: Nursing Faculty of the Islamic Republic of Iran Army- end of Kaj St- Shariati St- Tehran
Postal code: 6717855379 E-mail: https://mail.ajaums.ac.ir/ Website of Aja Nursing School: https://nursing.ajaums.ac.ir/
What processes are involved for a request to access data/document
It takes about 1 month to access information through the faculty