The effectiveness of emotional schema therapy on the modification of emotional schemas and difficulties of emotional regulation in women with irritable bowel syndrome: single-subject design
The method of research is of single-subject design type. It was used A-B schema with stepwise method. Generally, the first position (A) is the basic line, in second position (B) is performed a therapeutic intervention and then, dependent variable is evaluated. Statistical people included all women with irritable bowel syndrome that came to the office of a specialist in Isfahan in summer of 2016. Five people were selected as available sampling based on the participation willingness of individuals to the research and taking criteria for inclusion of study (having ROME III diagnostic criteria confirmed by digestion specialist for differentiation IBS from other functional gastrointestinal disordersTreatment was started with stepwise method with one week interval so that first patient initially enters to the therapy schema. In second treatment session of first patient, second patient enters to the treatment schema and in third therapy session of first patient and sec session of second patient, third patient and as the same way to fifth patient enter to treatment schema. Emotional schema therapy was implemented according to the Leahy therapeutic protocol through 12 sessions
General information
Acronym
EST
IRCT registration information
IRCT registration number:IRCT2016022826807N1
Registration date:2017-08-05, 1396/05/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
Arefeh Erfan
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 913 322 8083
Email address
a_erfan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of emotional schema therapy on the modification of emotional schemas and difficulties of emotional regulation in women with irritable bowel syndrome: single-subject design
Public title
The effectiveness of emotional schema therapy on the modification of emotional schemas and difficulties of emotional regulation with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria (having ROME III diagnostic criteria confirmed by digestion specialist for differentiation IBS from other functional gastrointestinal disorders, no consumption of psychiatry drugs during three months ago, no participation in psychology interventions session during six months ago, having high school education or higher, dominance on Persian language, have satisfaction for participation) and Exclusion criteria (having symptoms such as gastrointestinal blooding, existence of blood in excretion, fever, losing weight, anemia during six months ago, nnocturnal diarrhea, bellyache that awakes patients from sleep, palpable mass in physical examination , older than 50 and younger than 20, having a family history of colon cancer, having sever psychiatry disease)
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The method of research is of single-subject design type. It was used A-B schema with stepwise method. Generally, the first position (A) is the basic line, in second position (B) is performed a therapeutic intervention and then, dependent variable is evaluated. In the study, independent variable is emotional schema therapy and dependent variables are therapeutic variations due use of the treatment method on the modification of emotional schemas and emotion regulation difficulty
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University Ethics Committee
Street address
enghelab tehran university of medical sciences
City
tehran
Postal code
iran
Approval date
2017-06-24, 1396/04/03
Ethics committee reference number
13962719
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
k58.0
ICD-10 code description
Irritable bowel syndrome with diarrhoea
2
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
k58.0
ICD-10 code description
Irritable bowel syndrome with diarrhoea
Primary outcomes
1
Description
emotional schemas
Timepoint
baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months
Method of measurement
baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months
2
Description
Emotion regulation difficulty
Timepoint
baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months
baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months
Method of measurement
DASS
4
Description
severity and frequency of physical symptoms
Timepoint
baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months
Method of measurement
BSS-FS
5
Description
quality of life
Timepoint
baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months
Method of measurement
quality of life quation for IBS
Secondary outcomes
empty
Intervention groups
1
Description
. It has been presented a summary of content of sessions of emotional schema therapy in Table 1.
Table 1: a summary of content of sessions of emotional schema therapy
Sessions Content of sessions
First session Formation of therapeutic relation, planning of case formulation, presentation of treatment logic and treatment aims, presentation of etiologic model and treatment from emotional schema therapy approach
Second session Normal and problematic emotions, consideration of painful emotions of patients and normalization of them, emotion self-awareness, instruction and introduction of emotion, identification and labeling of emotion, differentiation between different emotions, identification of emotion in physical and psychological state
Third session Self-evaluation with the aim to recognize own emotion experiences, self-evaluation with the aim to identification of the amount of individuals emotion vulnerability, self-evaluation with the aim to identification of the strategies for emotion regulation, cognitive issues of emotion responses, physiologic issues of emotion responses, behavior outcomes of emotion responses and relation among them, introduction of rage emotion and the ways for dominance on rage
Forth session Proceeding identified emotional schemas in patient, verbal challenges and Socratic dialogue
Fifth session Proceeding other identified emotional schemas in patient and verbal challenges and Socratic dialogue, instruction of the technique of writing of negative memorabilia with the aim to facility of emotion processing
Sixth session prevention of social seclusion and avoidance, instruction of strategy of problem solving, training of interpersonal skills (talking, self-expression and conflict resolution), preliminary introduction of the conception of acceptance and emotion validation
Seventh session Helping people for acceptance of own emotion, proceeding intervening emotional schemas in acceptance and experience of painful emotion, presentation of detached mindfulness technique
Eighth session Introduction of kinds of negative beliefs about emotions and challenge to them, identification of false evaluation and their effects on the emotion states
Ninth session Identification of the amount and the way of using of inhibition strategy and investigation of its emotion outcomes, instruction of emotion expression, encounter, training of abreaction, relaxation
Tenth session Discussion about severity of schemas before and after of confrontation, proceeding reminder avoidance of patient
Eleventh session Review of sessions and practice of learned skills
Twelfth session Work on therapy program (prevention of recurrence), schematization for support sessions, homework, commitment to continuous usage of treatment practices
According to the observed therapeutic sessions’ content, therapist used a skill for patients and clarified it with examples of themselves.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Office Dr Peyman Adibi Gastroenterologist
Full name of responsible person
Street address
City
Isfahan,Facing Shariati Hospital,Shariati Building
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of medical Sciences
Full name of responsible person
Tehran university of medical Sciences
Street address
Tehran university of medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran university of medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Arefeh Erfan
Position
MSc
Other areas of specialty/work
Street address
Tehran university of Medical Sciences
City
Tehran
Postal code
Phone
+98 31 5350 1423
Fax
Email
a_erfan@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university Of Medical Sciences
Full name of responsible person
Arefeh Erfan
Position
MSc
Other areas of specialty/work
Street address
Tehran university Of Medical Sciences
City
Tehran
Postal code
Phone
+98 31 5350 1423
Fax
Email
a_erfan@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
tehran university Of Medical sciences
Full name of responsible person
arefeh erfan
Position
MSc Clinical Psycology
Other areas of specialty/work
Street address
tehran
City
tehran
Postal code
Phone
+98 31 5350 1423
Fax
Email
a_erfan@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)