Investigating the effect of spiritual group therapy on alexithymia in depressed patients referred to Modares Psychiatric hospital in Isfahan province, 2020
Design
This study is a non-blinded clinical trial with a parallel design and a control group. The study population will include all depressed patients referred to the psychiatric ward of Ayatollah Modarres hospital of Isfahan. Sixty two (62) eligible patients will be selected conveniently. A random number table is used for randomization and participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Ayatollah Modarres hospital of Isfahan, is a non-blinded one. At the beginning of the study, the Alexithymia questionnaire will be provided for patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 to 40 years; Patients with a diagnosis of major depression; Patients with bipolar disorder diagnosis in the depressive phase.
Non-inclusion criteria: Patients with bipolar disorder in the manic phase
Intervention groups
The intervention group according to the protocol of spiritual group therapy (Richards and Bergin), will be taught 8 90-minute sessions in three days a week. The control group will not receive any training.
Main outcome variables
Alexithymia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N159
Registration date:2021-01-13, 1399/10/24
Registration timing:registered_while_recruiting
Last update:2021-01-13, 1399/10/24
Update count:0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-09, 1399/10/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of spiritual group therapy on alexithymia in depressed patients
Public title
The effect of spiritual group therapy on alexithymia in depressed patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 40 years old
Patients with a diagnosis of major depression
Patients with bipolar disorder diagnosis in the depressive phase
Exclusion criteria:
Patients with bipolar disorder in the manic phase
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 62. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group
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 Azad University, Khorasgan Branch
Street address
Daneshgah Blvd, Arghavaniyeh, East Jay street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2020-09-16, 1399/06/26
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.170
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
Alexithymia
Timepoint
The beginning of the study and the end of the study
Method of measurement
Using the Toronto Alexithymia Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group according to the protocol of spiritual group therapy (Richards and Bergin), will be taught 8 90-minute sessions in three days a week
Category
Other
2
Description
The control group will not receive any training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Modarres Hospital
Full name of responsible person
Tahereh Ahmadian Najafabadi
Street address
Ayatollah Modarres Hospital; 18th km of Najafabad; Najafabad
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 4223 2086
Email
T.ahmadian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mahsasadat Mosavi
Street address
Daneshgah Blvd, Arghavaniyeh, East Jay street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.mousavi@khuisf.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
Tahereh Ahmadian Najafabadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshgah Blvd, Arghavaniyeh, East Jay street
City
Kermanshah
Province
Kermanshah
Postal code
8155139998
Phone
+98 31 3535 4001
Email
T.ahmadian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Roya Torkashvand
Position
Faculty member of Khorasgan Branch of Azad University Masters student
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatric Nursing
Street address
Daneshgah Blvd, Arghavaniyeh, East Jay street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
T.ahmadian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Tahereh Ahmadian Najafabadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshgah Blvd, Arghavaniyeh, East Jay street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
T.ahmadian@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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