The effectiveness of compassion-focused therapy on treatment outcome in patients with bipolar disorder
Design
A clinical trial with a control group, with parallel, randomized, phase 2 groups will be performed on 40 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 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 criteria: Age between 18 and 50 years, Diagnostic Criteria - SCID-5-CV for type 1 and 2 bipolar disorder, Not in the acute phase of the disease, Have a regular medication regimen, Score less than -17 on the Young Mania Test
Exclusion criteria: History of brain injury, dementia, and specific neurological disease, Not using any addictive drugs, Severe physical illnesses such as cancer
Intervention groups
Intervention group: in addition to standard drug treatment, receive treatment focused on compassion. Control group: This group will only receive world standard medical treatment and will not receive compassion treatment.
Main outcome variables
Compassion for yourself
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211206053298N1
Registration date:2022-04-30, 1401/02/10
Registration timing:registered_while_recruiting
Last update:2022-04-30, 1401/02/10
Update count:0
Registration date
2022-04-30, 1401/02/10
Registrant information
Name
Forouzan Behrouzian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
abdi.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Compassion-Focused Therapy on Treatment Outcome in Patients With Bipolar Disorder
Public title
The effectiveness of compassion-focused therapy on treatment outcome in patients with bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 50 years
Diagnostic Criteria - SCID-5-CV for type 1 and 2 bipolar disorder
Not in the acute phase of the disease
Have a regular medication regimen
Score less than -17 on the Young Mania Test
Exclusion criteria:
History of brain injury, dementia and specific neurological disease
Not using any addictive drugs
Severe physical illnesses such as cancer
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
20
The sample size for each group will be 20 people.
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the intervention to individuals is randomly divided into two groups of intervention and control by the method of random permutation blocks with a size of 4 random blocks (using the table related to random permutations). The randomization list is prepared by a statistician. 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.T o hide the assignment of individuals in the intervention and control groups, 20 even four-digit numbers will be selected as the codes of the participants in the control group and 20 four-digit individuals as the codes of the participants in the intervention group will be selected from a random number table. Then, the numbers of intervention and control groups are placed in sealed envelopes, respectively, and are randomly delivered by one of the personnel to the eligible individuals participating in the study. Random allocation software is also used for randomization. The site https://www.randomizer.org/ is used for randomization. In the empty fields, the total number of random numbers and the number of random numbers in each group, the range of numbers are entered and the output is received as an excel.
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 Jundishapur University of of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2021-11-09, 1400/08/18
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.120
Health conditions studied
1
Description of health condition studied
The effectiveness of compassion-focused therapy on treatment outcome in patients with bipolar disorder
ICD-10 code
F31.7
ICD-10 code description
Bipolar disorder, currently in remission
Primary outcomes
1
Description
Self-compassion
Timepoint
Before, after and two months after treatment
Method of measurement
Demographic Characteristics Questionnaire and Structured Clinical Interview, Distress on Bipolar Patients-Short, Self-Critical Rumination Scale
2
Description
external and internal shame
Timepoint
Before, after and two months after treatment
Method of measurement
Shame Scale
3
Description
self-criticism
Timepoint
Before, after and two months after treatment
Method of measurement
Self-Critical Rumination Scale
4
Description
psychological distress
Timepoint
Before, after and two months after treatment
Method of measurement
Distress on Bipolar Patients-Short
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 jects in the experimental group individually. That is, treatment sessions will be conducted individually and in the presence of the therapist and the patient. That is, 20 people will see the experimental group individually, one session per week, and the questionnaire will be filled out before the first session, after the last session, and two months after the last session, and the results will be analyzed as a group
Category
Treatment - Other
2
Description
Control group: After the patients are selected, based on the treatment group, the patients are treated with world standard medicine and after the treatment, the information is re-evaluated. In this group, no compassion treatment is performed. Medication varies according to the patient's condition and the doctor's prescription.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Forouzan Behrouzian
Street address
Ahvaz Golestan Hospital ,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
4693955599
Phone
+98 61 3320 4501
Email
behrouzian-f@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Street address
Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Phone
+98 917 311 6725
Fax
Email
behrouzian-f@ajums.ac.ir
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
Forouzan Behrouzian
Position
Assistant Professor
Latest degree
Ph.D.
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 3001
Fax
Email
abdi.l@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Position
Assistant Professor
Latest degree
Ph.D.
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 3001
Fax
Email
abdi.l@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shima Nemati jole karan
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Phone
+98 911 281 2156
Email
drshimanemati@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available