Protocol summary

Study aim
Investigating mindfulness- based cognitive therapy on quality of life, psychological acceptance and self-compassion in peaple with emotional failure
Design
Single-subject experimental design using the baseline method (with three baselines) and a one-month follow-up period Samples(voluntary) were invited through advertisement. In the beginning, 9 people applied and during the initial interview, 6 people who met the conditions to enter the research were selected, and one person was removed during the research due to having criteria for exiting the research.
Settings and conduct
At first, all the necessary permits to conduct the research were received. The participants included 3 girls and 3 boys; At the beginning, once a week, the questionnaires related to love shock syndrome, quality of life, psychological acceptance and compassion were administered, which were embedded virtually and in Google Form, and the link It was made available to the participants to fill out. Then cognitive therapy intervention based on mindfulness in the form of 8 one-hour sessions Began. And in the third, fifth and eighth sessions, the questionnaires were filled again by the participants.
Participants/Inclusion and exclusion criteria
Being in the age range of 18 to 38 years Obtaining an emotional failure scale score above 15 Lack of experience of: death of first degree family members/ psychiatric drug/ substance abuse/other treatments/Consent to participate in meetings until the end of treatment
Intervention groups
this design can show the stability of the effects of the intervention for each person
Main outcome variables
Cognitive therapy based on mindfulness is effective on emotional failure and variables such as quality of life, psychological acceptance and compassion.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230727058943N1
Registration date: 2023-08-20, 1402/05/29
Registration timing: retrospective

Last update: 2023-08-20, 1402/05/29
Update count: 0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
donya fami tafreshi
Name of organization / entity
The University of khatam
Country
Iran (Islamic Republic of)
Phone
+98 21 4473 5152
Email address
d.tafreshi@khatam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
2023-03-21, 1402/01/01
Actual recruitment end date
2023-04-21, 1402/02/01
Trial completion date
2023-07-30, 1402/05/08
Scientific title
The effectiveness of mindfulness- based cognitive therapy on quality of life, psychological acceptance and self-compassion in peaple with emotional failure
Public title
The effectiveness of mindfulness- based cognitive therapy in peaple with emotional failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the age range of 18 to 38 years Obtaining an emotional failure scale score above 15 Consent to attend and participate in meetings until the end of treatment
Exclusion criteria:
The experience of the death of family members Taking psychiatric drugs Drug abuse Use of other treatments
Age
From 18 years old to 38 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 6
Actual sample size reached: 5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University
Street address
Khatam University, No. 30, Hakim Azam St., Shiraz Shamali St., Mollasadra St., Tehran
City
Tehran
Province
Tehran
Postal code
1991633357
Approval date
2023-03-07, 1401/12/16
Ethics committee reference number
IR.SBU.REC.1402.071

Health conditions studied

1

Description of health condition studied
emotional failure
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effectiveness of mindfulness-based cognitive therapy on emotional failure
Timepoint
At first, once a week (in three consecutive weeks to determine the baseline) and then after the intervention in sessions 3, 5 and 8
Method of measurement
Ross love failure questionnaire

Secondary outcomes

1

Description
quality of life
Timepoint
At first, once a week (in three consecutive weeks to determine the baseline) and then after the intervention in sessions 3, 5 and 8
Method of measurement
World Health Organization Quality of Life Questionnaire (WHO-QOL-BREF) short form

2

Description
psychological acceptance
Timepoint
At first, once a week (in three consecutive weeks to determine the baseline) and then after the intervention in sessions 3, 5 and 8
Method of measurement
Acceptance and Action Questionnaire - Second Edition (AAQ-II)

3

Description
self-compassion
Timepoint
At first, once a week (in three consecutive weeks to determine the baseline) and then after the intervention in sessions 3, 5 and 8
Method of measurement
Compassion Questionnaire (SCS-SF)

Intervention groups

1

Description
Intervention group: Using cognitive therapy protocol based on mindfulness in 8 sessions
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
There was no special center
Full name of responsible person
Donya fami tfreshi
Street address
Khatam University, No. 30, Hakim Azam St., Shiraz Shamali St., Mollasadra St., Tehran
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 0000
Email
d.tafreshi@khatam.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khatam University
Full name of responsible person
Dr. Bahauddin Shariat
Street address
Khatam University, No. 30, Hakim Azam St., Shiraz Shamali St., Mollasadra St., Tehran
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 0000
Email
d.tafreshi@khatam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Khatam University
Proportion provided by this source
100
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
Khatam University
Full name of responsible person
donya fami tafreshi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khatam University, No. 30, Hakim Azam St., Shiraz Shamali St., Mollasadra St., Tehran
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 0000
Email
d.tafreshi@khatam.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khatam University
Full name of responsible person
Marzieh Hashemi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khatam University, No. 30, Hakim Azam St., Shiraz Shamali St., Mollasadra St., Tehran
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 0000
Email
m.hashemi2@khatam.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Khatam University
Full name of responsible person
donya fami tafreshi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khatam University, No. 30, Hakim Azam St., Shiraz Shamali St., Mollasadra St., Tehran
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 0000
Email
d.tafreshi@khatam.ac.ir

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
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Title and more details about the data/document
It will be published as an article
When the data will become available and for how long
After the defense at the end of September
To whom data/document is available
researchers
Under which criteria data/document could be used
I have no special conditions
From where data/document is obtainable
Researcher and University
What processes are involved for a request to access data/document
It will be published as an article
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