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The Effectiveness of Self-Compassion-Focused Therapy on Cognitive Vulnerability to Depression in Students of Bu-Ali Sina University

Protocol summary

Study aim
The objective of the present study was to determine the effectiveness of self-compassion-focused therapy on cognitive vulnerability to depression as one of the causes of the onset or recurrence of depressive episodes in people who were not depressed at the time of the research but were cognitively susceptible to depression.
Design
Clinical trial with control group, Sampling was done in two stages; First, 311 series of questionnaires by available sampling method were provided to students for screening., then according to the research criteria, 52 people were screened at this stage, and finally, by random assignment, 20 people were placed in the experimental group and 20 people in the control group.
Settings and conduct
. A self-compassion-focused therapy package was administered to the experimental group for eight 90 minutes sessions. However, the control group did not receive any treatment. The intervention was performed online (with Skype), by a specialist psychologist who had been trained in self-compassion-focused therapy courses.
Participants/Inclusion and exclusion criteria
The inclusion criteria included depression z scores of less than 1, dysfunctional attitude scores of higher than 128, attribution style and cognitive triad z scores of higher than 1, and self-esteem z scores of below 1; these individuals should have a cognitive vulnerability to depression. The inclusion criteria included the lack of depression symptoms and psychotherapy in the past two months.
Intervention groups
The experimental group underwent compassion-focused therapy for 8 sessions of 90 minutes. The control group: the control group did not receive any treatment
Main outcome variables
increasing self-esteem; reducing internal, stable, and general attribution styles in negative situations; reducing dysfunctional attitudes; reducing cognitive vulnerability to depression.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220907055911N1
Registration date: 2022-09-29, 1401/07/07
Registration timing: retrospective

Last update: 2022-09-29, 1401/07/07
Update count: 0
Registration date
2022-09-29, 1401/07/07
Registrant information
Name
Mehran Farhadi
Name of organization / entity
Bu-Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1601
Email address
mehran.farhadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
2020-05-04, 1399/02/15
Actual recruitment end date
2020-05-20, 1399/02/31
Trial completion date
2020-10-21, 1399/07/30
Scientific title
The Effectiveness of Self-Compassion-Focused Therapy on Cognitive Vulnerability to Depression in Students of Bu-Ali Sina University
Public title
The effect of self-compassion on cognitive vulnerability to depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All students of Bu-Ali Sina University (Before screening) The lack of depression symptoms (After screening) Not receiving psychotherapy services in the past two months (After screening) These individuals should have a cognitive vulnerability to depression (After screening)
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 311
Actual sample size reached: 311
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done in two stages; First, for the purpose of screening, 311 series of questionnaires were provided to the students by available sampling method, then according to the criteria of the research, 52 people were screened at this stage. First, 40 people were randomly selected (40 questionnaire codes were selected by lottery from among the 52 available codes), and finally, these 40 people were randomly assigned (again, by lottery from among the 40 available codes, one of the selected codes was assigned to experimental and control groups were assigned), 20 people were in the experimental group and 20 people were in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
It has an experimental group and a control group, the experimental group all underwent the same type of intervention, but the control group did not receive any intervention. Pre-test and post-test were performed on both groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Hamedan of University of Bu-Ali Sina
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.BASU.REC.1399.008

Health conditions studied

1

Description of health condition studied
Cognitive Vulnerability to Depression
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cognitive vulnerability score to depression
Timepoint
Before the start of the intervention and four days after the end of the intervention
Method of measurement
(According to the score of the Beck Depression Inventory, these people should not be depressed at the time of the intervention (z-scores less than 1) and also according to the scores of the dysfunctional attitude scale (scores of higher than 128), attribution style questionnaire and Cognitive Triad Inventory (z-scores of higher than 1) and self-esteem scale (z-scores lower than 1), these individuals should have cognitive vulnerability to depression.

2

Description
Dysfunctional attitudes score
Timepoint
Before the start of the intervention and four days after the end of the intervention
Method of measurement
Dysfunctional Attitude Scale and Cognitive Triad Inventory

3

Description
reducing internal, stable, and general attribution styles in negative situations score
Timepoint
Before the start of the intervention and four days after the end of the intervention
Method of measurement
Attributional Style Questionnaire

4

Description
Self-esteem score
Timepoint
Before the start of the intervention and four days after the end of the intervention
Method of measurement
Rosenberg Self-Esteem Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group underwent compassion-focused therapy for 8 sessions of 90 minutes. Neff, defined self-compassion as a three-component construct, which includes kindness to oneself versus self-judgment, human sharing versus isolation, and vigilance versus extreme assimilation. Therefore, Gilbert used this structure in the treatment sessions, and finally proposed self-compassion-focused therapy. In fact, self-compassion-focused therapy focuses on the four areas of past and historical experiences, underlying fears, strategies for being safe, and unintended consequences. self-compassion-focused therapy package was developed and designed based on the theoretical guidelines of Gilbert’s compassionate mind. Session one, purpose: introduction and general explanations. content: familiarity with members, workshop rules, members' goals for attending the meetings, the logic of intervention sessions, the definition of compassion, the importance and the effects of compassion. Session two, purpose: introducing emotional regulation systems. content: introducing three emotional regulation systems and the way they affect the individual; explaining the difference between a threat-focused mind and a compassionate mind. Session three, purpose: introducing mindfulness technique. content: teaching relaxing breath and the way to perform it; introducing mindfulness skills, physical examination techniques, moment-to-moment attention, and conscious eating (e.g., raisin eating practice). Session four, purpose: introducing the characteristics of compassion and a compassionate person. content: explaining the six characteristics of compassion (i.e., sensitivity, well-being care, empathy, sympathy, non-judgment, and tolerance of turmoil); defining a compassionate person and his characteristics (i.e., wisdom, power, kindness, non-judgment, and responsibility); explaining the fact that the client must learn skills in order to become a compassionate person. Session five, purpose: introducing compassionate reasoning and compassionate attention. content: teaching how to visualize self-compassion; imagining your best state; performing the technique of compassionate chair. Session six, purpose: introducing techniques to cultivate a compassionate mind. content: reconstructing hard emotional memories through focusing on compassionate identity; further cultivating the relief system; building a compassionate inner relationship. Session seven, purpose: introducing compassionate feeling (showing compassion to others and receiving compassion from them). content: practicing self-compassion; creating an ideal and complete compassionate model; having a brief reference to the concept of fear of compassion. Session eight, purpose: introducing compassionate behaviors. content: explaining the true meaning of compassionate behaviors; generating ideas for compassionate behaviors; teaching compassionate letter writing and summarizing.
Category
Other

2

Description
Control group: The control group did not receive any treatment.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bu-Ali Sina University
Full name of responsible person
Mehran Farhadi
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Email
mehran.farhadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Ghorbani-Choghamarani Arash
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Email
a.ghorbani@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu-Ali Sina 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
Bu-Ali Sina University
Full name of responsible person
Haniyeh Rahimi
Position
Graduated
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Email
haniehrahimi95@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Mehran Farhadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Email
mehran.farhadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Haniyeh Rahimi
Position
Graduated
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Email
haniehrahimi95@gmail.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
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
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