Evaluation effectiveness of compassion-focused therapy on shame and self-criticism in patients with a psychotic disorder
Design
A clinical trial with a control group, with parallel, randomized, phase 2 groups will be performed on 60 patients. The random block method is used.
Settings and conduct
A clinical trial with a control group, with parallel, randomized, phase 2 groups will be performed on 60 patients. The random block method is used. Intervention is a method for people with the psychotic disorder to receive 10 sessions of psychotherapy. This study will be performed on patients admitted to Golestan Hospital in Ahvaz. Blinding is not applicable to this study.
Participants/Inclusion and exclusion criteria
Inclusion condition: Patients with a psychotic disorder
Exclusion criteria: History of any mental disorder
Intervention groups
Intervention group: After the patients are selected, based on the treatment group, the patients are placed in the intervention group and receive treatment focused on compassion, and after treatment, their shame and self-criticism will be assessed by a questionnaire.
Control group: After the patients are selected, based on the treatment group, the patients are placed in the control group and receive normal treatment, and then their shame and self-criticism will be assessed by a questionnaire.
Main outcome variables
self-criticism
shame
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161228031626N5
Registration date:2021-12-31, 1400/10/10
Registration timing:retrospective
Last update:2021-12-31, 1400/10/10
Update count:0
Registration date
2021-12-31, 1400/10/10
Registrant information
Name
Hatam Boostani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
tabibi.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-30, 1400/01/10
Expected recruitment end date
2021-04-01, 1400/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effectiveness of compassion-focused therapy on shame and self-criticism in patients with a psychotic disorder
Public title
Evaluation effectiveness of compassion-focused therapy on shame and self-criticism in patients with psychotic disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with psychotic disorder
Exclusion criteria:
History of other mental illness disorders
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to divide patients into two groups, the randomized block method is used. In this method, group A is related to the intervention and group B is considered as the control and is classified into 4 blocks including AABB, ABAB, ABBA, BBAA, BABA, BAAB, according to the selected permutations. The patient is classified into one of the intervention or control groups. Random allocation software was used for randomization
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 Ahvaz Jundishapur University of of Medical Sciences
Street address
Ahvaz Golestan Hospital ,Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.062
Health conditions studied
1
Description of health condition studied
psychotic disorder
ICD-10 code
F23
ICD-10 code description
Brief psychotic disorder
Primary outcomes
1
Description
shame
Timepoint
Before and after intervention
Method of measurement
Self-Compassion Scale (SCS questioner)
2
Description
self-criticism
Timepoint
Before and after intervention
Method of measurement
Self-Compassion Scale (SCS questioner)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the patients are selected, based on the treatment group, the patients are treated with compassion-focused treatment and after the treatment, the information is re-evaluated. The compassion-focused treatment protocol will be implemented in accordance with the content of the treatment in 10 sessions. The basic principles of compassion-focused therapy point out that external soothing thoughts, factors, images, and behaviors must be internalized, and in this case, the human mind, as it responds to external factors, in the face of this Relax inside. Sessions 1 and 2: Evaluation based on compassion-focused treatment approach, Session 3: Understanding compassion, Session 4: Preparing clients to improve compassionate attention and concentration, Session 5: Illustration of daily compassion, Session 6: Examining the role of self-criticism and shame using the metaphor of two teachers, introducing compassionate self, Session 7: Introducing multiple selves references, exercising multiple selves, Session 8: Compassionate thinking and argument and compassionate behavior, Session 9: Balancing thinking and mind in a compassionate way, Session 10: Writing a letter of compassion
Category
Treatment - Other
2
Description
Control group: After the patients are selected, the patients are treated normally based on the group therapy and the information is re-evaluated after the treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Hatam Boostani
Street address
Ahvaz Golestan Hospital ,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Phone
+98 61 3374 3038
Email
boostani.h@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hatam Boostani
Street address
Ahvaz Golestan Hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Phone
+98 61 3374 3038
Email
Boostani_h@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Phone
+98 61 3374 3038
Email
Boostani_h@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Phone
+98 61 3374 3038
Email
Boostani_h@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Khalafi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Jundishapur University of Medical Sciences,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Phone
+98 61 3374 3038
Email
peymann_600@mail.ru
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD