Protocol summary

Study aim
The purpose of this study was to study the effectiveness of self-compassion therapy on distress tolerance, cognitive avoidance, depression, and emotional resilience of depressed women referring to psychological counseling centers.
Design
A randomized, open-label, controlled clinical trial was conducted on 40 patients for randomization.
Settings and conduct
40 women with depressive disorder will be randomly selected from four counseling and psychological service centers in Ahvaz, 20 of whom will be assigned to the experimental group and 20 to the control group. After the groups were formed, the subjects were led to special rooms and given questionnaires to measure the variables as a pre-test. After completing the training course, both the experimental and control groups were re-measured with questionnaires to measure the variables as a post-test.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: 1- Female gender 2- Marriage period of maximum 3 years 3- No serious physical or mental illness 4- Score between 20 and 28 on the Beck Depression Inventory Exclusion criteria: 1- Presence of concurrent mental disorders, psychosis spectrum disorders, and substance abuse 2- Absence of more than two sessions
Intervention groups
After forming the groups, the subjects were led to special rooms and given questionnaires to measure the variables as a pre-test. The people in the experimental group participated in training courses for about 1 month and received compassion-focused therapy intervention in 8 90-minute sessions, two sessions per week. There was no intervention for the control group. After completing the training course, both the experimental and control groups were re-assessed with questionnaires to measure the variables as a post-test.
Main outcome variables
Self-Compassion Therapy, Distress Tolerance, Cognitive Avoidance, Depression, Emotional Resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250711066449N1
Registration date: 2025-07-17, 1404/04/26
Registration timing: registered_while_recruiting

Last update: 2025-07-17, 1404/04/26
Update count: 0
Registration date
2025-07-17, 1404/04/26
Registrant information
Name
Foroozan raeesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3632 1292
Email address
forouzan.reisi@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-16, 1404/04/25
Expected recruitment end date
2025-08-11, 1404/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of self-compassion therapy on distress tolerance, cognitive avoidance, depression and emotional resilience of depressed women referred to psychological counseling centers.
Public title
Studying the effectiveness of self-compassion therapy on distress tolerance, cognitive avoidance, depression and emotional resilience of depressed women referred to psychological counseling centers.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender Marriage period of maximum 3 years No serious physical or mental illness Score between 20 and 28 on the Beck Depression Inventory Age 20 to 40 years
Exclusion criteria:
Presence of concurrent mental disorders, psychosis spectrum disorders, and substance abuse Absence of more than two sessions Not being under medication
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Among all the counseling and psychological service centers in Ahvaz, four centers were selected at random, and patients with depressive disorder who referred to these four centers for treatment and had received a diagnosis of depression from a psychiatrist and clinical specialist were selected. Of course, to ensure correct diagnosis, a diagnosis of depression was made based on the fifth edition of the Classification of Mental Disorders using a structured checklist. 67 patients were eligible (patients whose depression score was between 20 and 28 according to the Beck Depression Inventory and were in the moderate depression group. Also, these patients are in the drug treatment stage), of which 5 were unwilling to participate. Finally, 40 women were randomly selected (lottery) and considered as a sample, 20 of whom were assigned to the experimental group and 20 to the control group by simple random selection (lottery).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Ahvaz Branch
Street address
No. 65, Jomhuri Eslami Street
City
Gotvand
Province
Khouzestan
Postal code
6455155318
Approval date
2025-05-22, 1404/03/01
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.080

Health conditions studied

1

Description of health condition studied
Distress, cognitive avoidance, depression and emotional resilience in depressed women
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
The effectiveness of self-compassion therapy on distress tolerance, cognitive avoidance, depression, and emotional resilience. Compassion-focused therapy is a form of evidence-based therapy that specifically targets the development of compassion. This therapy emphasizes strengthening the ability to be aware of suffering as well as the motivation and ability to heal or prevent it. After forming the groups, the subjects were led to special rooms and were given questionnaires to measure the dependent variables (depression, distress tolerance, cognitive avoidance, emotional resilience) as a pre-test and were assured that their answers would remain confidential. They were asked to answer the questions confidently and honestly. People in the experimental group participated in training courses for about 1 month and received compassion-focused therapy intervention in 8 90-minute sessions, two sessions per week. Also, no intervention was given to the control group. However, to prevent threats to the internal validity of the test, the intervention was administered to them after the end of the study. After completing the training period, both experimental and control groups were re-assessed using questionnaires that measured dependent variables (depression, distress tolerance, cognitive avoidance, emotional resilience) as a post-test.
Timepoint
The present study was conducted in the form of a semi-experimental field research design with a control group and within the framework of a pre-test and post-test design. In this design, the subjects were measured before implementing the independent variable (pre-test), then the experimental intervention or independent variables were applied. After that, the subjects were measured again. The sessions of this study were designed based on the book Compassion-Focused Therapy, which is based on the Compassion-Focused Therapy Package based on Gilbert's concepts (2010), and were conducted in 8 90-minute sessions. This protocol was translated by Eshabati and Feyzi in 2016.
Method of measurement
The effectiveness of self-compassion therapy on distress tolerance, cognitive avoidance, depression, and emotional resilience was measured by the Beck Depression Inventory II (long form), cognitive avoidance questionnaire, distress tolerance questionnaire, and emotional resilience scale.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Among all the counseling and psychological services centers in Ahvaz, four centers were selected at random, and patients with depressive disorder who had referred to these four centers for treatment and had received a diagnosis of depression from a psychiatrist and clinical specialist were selected. Of course, to ensure a correct diagnosis, a diagnosis of depression was made based on the fifth edition of the classification of mental disorders using a structured checklist. 67 patients were eligible (patients whose depression score was between 20 and 28 according to the Beck Depression Inventory and were included in the moderate depression group. Also, these patients are in the drug treatment stage), of which 5 were unwilling to participate. Finally, 40 women were randomly selected (lottery) and considered as a sample, 20 in the experimental group and 20 in the control group were assigned by simple random selection (lottery).1. After the groups were formed, the subjects were led to special rooms and were given questionnaires to measure the variables as a pre-test.2. The people in the experimental group participated in training courses for about 1 month and received compassion-focused therapy intervention in 8 90-minute sessions, two sessions per week. 3. After completing the training course, a experimental group were re-assessed with questionnaires that were used to measure the variables as a post-test.
Category
Behavior

2

Description
Control group: Among all the counseling and psychological services centers in Ahvaz, four centers were selected at random, and patients with depressive disorder who had referred to these four centers for treatment and had received a diagnosis of depression from a psychiatrist and clinical specialist were selected. Of course, to ensure a correct diagnosis, a diagnosis of depression was made based on the fifth edition of the classification of mental disorders using a structured checklist. 67 patients were eligible (patients whose depression score was between 20 and 28 according to the Beck Depression Inventory and were included in the moderate depression group. Also, these patients are in the drug treatment stage), of which 5 were unwilling to participate. Finally, 40 women were randomly selected (lottery) and considered as a sample, 20 in the experimental group and 20 in the control group were assigned by simple random selection (lottery).1. After the groups were formed, the subjects were led to special rooms and were given questionnaires to measure the variables as a pre-test.2. No intervention was performed for the control group. However, to prevent threats to the internal validity of the test, the intervention was administered to them after the end of the study.3. After the training period, the control group was re-assessed with questionnaires that were used to measure the variables as a post-test.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sychological counseling and service centers
Full name of responsible person
Forouzan Raeisi
Street address
No. 65, Jomhuri Eslami Street
City
Gotvand
Province
Khouzestan
Postal code
6455155318
Phone
+98 61 3632 1292
Email
forouzan.reisi@iau.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pezhman Taghipour Birgani
Street address
Opposite Keshavarz street, Farhang shahr, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹۳۷۳۳۳
Phone
+98 61 3316 3394
Email
P_taghipour@iauahvaz.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
10
Public or private sector
Private
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
Forouzan Raeisi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 65, Jomhuri eslami street
City
Gotvand
Province
Khouzestan
Postal code
6455155318
Phone
+98 61 3632 1292
Email
forouzan.reisi@iau.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forouzan Raeisi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 65, Jomhuri eslami street
City
Gotvand
Province
Khouzestan
Postal code
6455155318
Phone
+98 61 3632 1292
Email
forouzan.reisi@iau.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forouzan Raeisi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 65, Jomhuri eslami street
City
Gotvand
Province
Khouzestan
Postal code
6455155318
Phone
+98 61 3632 1292
Email
forouzan.reisi@iau.ir

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Loading...