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The effect of quality of life therapy on hopefulness and health related quality of life in patients with major depressive disorder

Protocol summary

Study aim
Determining The effect of group quality of life therapy on hopefulness and health related quality of life in patients with major depressive disorder
Design
A clinical trial with control group, parallel groups, single-blinded, randomized, on 60 patients. The randomized block method and the online site (mentioned in the previous section) will be used for randomization.
Settings and conduct
The study will be performed at Shahid Rajaei Psychiatric Hospital in Yasuj. Quality of life and hopefulness questionnaires will be filled out by both groups before the intervention. Then, for the intervention group, ten sessions of psychotherapy based on quality of life, will be performed, but for the control group, no intervention will be performed. At the end of the intervention, the research questionnaires will be filled out again by the participants. In this single-blinded study, the evaluator is unaware of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Having major depression diagnosed by a psychiatrist, Age over 18 years Exclusion criteria; Unwillingness or withdrawal from the company to continue the study.
Intervention groups
Intervention group: includes 30 patients for whom group psychotherapy based on quality of life will be held for 10 sessions a week for two sessions of one and a half hours. In these sessions, the characteristics of quality of life and its effect on living happily, teaching the CASIO model, respecting one's self, and the five branches of quality of life will be taught. Control group: includes 30 patients who will not receive any intervention during the study.
Main outcome variables
Quality of life - hopefulness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220317054323N1
Registration date: 2022-06-07, 1401/03/17
Registration timing: prospective

Last update: 2022-06-07, 1401/03/17
Update count: 0
Registration date
2022-06-07, 1401/03/17
Registrant information
Name
Milad Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3822 6416
Email address
milad.amiri@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-16, 1401/04/25
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of quality of life therapy on hopefulness and health related quality of life in patients with major depressive disorder
Public title
The effect of quality of life therapy on quality of life and hopefulness.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has major depression diagnosed by a psychiatrist The patient is cognitively able to understand the content and therapeutic training Simultaneously earning a quality of life score below 50 and a hope score below 24 Age over 18 years Willingness and satisfaction to participate in research
Exclusion criteria:
Have severe chronic physical disorders (cancer, multiple sclerosis) Participate in similar therapeutic interventions in the last quarter
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 60 patients with major depression who meet the inclusion criteria will be selected and randomly assigned to the intervention and control groups through block randomization. For block randomization, according to the total number of 60 patients and the existence of two groups, blocks with sizes of 2, 4, and 6 will be used. For example, if the size of block is 2, we will have two modes AB and BA (A and B are intervention and control groups). In order to create random allocation sequences and concealment, online software with the following address will be used, and a unique randomization code will be generated. Sealed Envelope Ltd. 2021. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 5 Jun 2022].
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluator or the person who evaluates the questionnaires in the pre-test and post-test stages is not aware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Shahid Motahari Blvd., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-05-18, 1401/02/28
Ethics committee reference number
IR.YUMS.REC.1401.013

Health conditions studied

1

Description of health condition studied
Major depressive disorder
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate

Primary outcomes

1

Description
Health related quality of life
Timepoint
Before the intervention - After the intervention
Method of measurement
The World Health Organization Health-related Quality of Life Questionnaire - Bref form. This is a 26-item questionnaire that measures a person's overall quality of life.

2

Description
Schneider hopefulness questionnaire. It has 12 questions and its purpose is to assess people's hopefulness.
Timepoint
Before the start of the study - after the intervention
Method of measurement
Schneider Hopefulness Questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: includes 30 patients for whom group psychotherapy based on quality of life will be held for 10 sessions a week for two sessions of one and a half hours.In these sessions, the characteristics of quality of life and its effect on living happily, teaching the CASIO model, respecting one's self, and the five branches of quality of life will be taught.
Category
Treatment - Other

2

Description
Control group: includes 30 patients who will not receive any intervention during the study. According to ethical considerations, if the results of the interventions are positive in the intervention group, at the end of the research, and if the patients of control group have informed consent, the intervention will be performed on the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mofteh Yasuj Clinic
Full name of responsible person
Bahram Mohamadi
Street address
Golestan No. 15
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591330015
Phone
+98 74 1222 3299
Email
milad.6916@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Hossein Mari Oryad
Street address
University of Medical Sciences, Motahhari Blvd, Kohgiluyeh and Boyer-Ahmad Provinces, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Mohamad Malekzadeh
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Yasuj - next to Imam Sajjad Hospital - Campus of Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5140
Email
mzh541@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohamad Malekzadeh
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Medical Sciences, next to Imam Sajjad Hospital, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5140
Email
mzh541@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohamad Malekzadeh
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Medical Sciences, next to Imam Sajjad Hospital, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5140
Email
mzh541@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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