The effect of brief psychodynamic psychotherapy with emphasis on Core conflict Relationship Theme on the improvement of physical and psychological health indexes in functional dyspepsia patients
The aim of this study is to investigate the effects a brief psychodynamic psychotherapy of Core conflict relationship theme (CCRT) on improvement of physical and psychological symptoms in patients with functional dyspepsia. A total of 30 women, aged 20-40 years old and diagnosed functional dyspepsia according to Rome III criteria are randomly assigned into experimental or control group. The participants of control group are taken standard pharmacotherapy for 6 weeks. The participants of experimental group are taken standard pharmacotherapy as well as attending in individual psychotherapy method of CCRT during 4 months (16 sessions, 50 minutes, once weekly). The patient’s assessment questionnaire of upper gastrointestinal disorder–symptom severity index, the Persian version of the twenty-item Torento Alexithymia scale, and SCL90-R will be completed at the beginning and at the end and 1-month after interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102285931N1
Registration date:2011-03-30, 1390/01/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-30, 1390/01/10
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modaress University
Expected recruitment start date
2011-01-13, 1389/10/23
Expected recruitment end date
2011-08-20, 1390/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of brief psychodynamic psychotherapy with emphasis on Core conflict Relationship Theme on the improvement of physical and psychological health indexes in functional dyspepsia patients
Public title
The effect of brief psychodynamic psychotherapy with emphasis on Core conflict Relationship Theme on the improvement of physical and psychological health indexes in functional dyspepsia patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women 20-40 and education diploma or above with normal test of endoscopy, sonography, and routine blood tests
Exclusion criteria: Irritable bowel syndrome, Paranoid personality, Schizoid personality
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tarbiat Modares University
Street address
AL-E-Ahmad highways, Chamran Intercection, Tehran
City
Tehran
Postal code
Approval date
2011-01-12, 1389/10/22
Ethics committee reference number
85387/60
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Dyspepsia
Primary outcomes
1
Description
Symptoms of functional dyspepsia
Timepoint
before and after treatment and 1 month after treatment
Method of measurement
Patient assessment of upper gastrointestinal disorder – symptom severity index,
Secondary outcomes
1
Description
psychological symptoms
Timepoint
before tratment, after treatment, and 1 month after treatment
Method of measurement
ScL-90
Intervention groups
1
Description
Intervention group: The patients with positive H. pylori will receive a combination of bismuth subcitrate (3×500 mg), metronidazole (3×250 mg), amoxicillin (3×500 mg) and either omeprazole (2×20 mg) (2×150 mg) for 2 weeks and continue omeprazole (2× 20 mg) (2 ×150 mg) only for 4 weeks. Patients with negative for H. pylori will receive omeprazole (2×20 mg) for 6 weeks as well as attending in individual psychotherapy for 16 sessions (50 minutes) every a week
Category
Behavior
2
Description
Control group: The patients with positive H. pylori will receive a combination of bismuth subcitrate (3×500 mg), metronidazole (3×250 mg), amoxicillin (3×500 mg) and either omeprazole (2×20 mg) (2×150 mg) for 2 weeks and continue omeprazole (2× 20 mg) (2 ×150 mg) only for 4 weeks. Patients with negative for H. pylori will receive omeprazole (2×20 mg) for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani hospital
Full name of responsible person
Dr. Hassan Taheri
Street address
Ayatillah Rohani hoaspital- Gang Afroz street- Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Parviz Azadfallah
Street address
AL-E-Ahmad highways, Chamran Intercection, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Faculty of member of Babol University of Medical Sciences- PhD student of Tarbiat modares university
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Gang Afroz Street- Babol
City
Babol University of Medical Sciences
Postal code
Phone
+98 11 1329 4456
Fax
+98 11 1329 4456
Email
mahbob330@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modaress University
Full name of responsible person
Parviz Azadfallah
Position
Associate professor
Other areas of specialty/work
Street address
AL-E-Ahmad highways, Chamran Intercection, Tehran
City
Tehran
Postal code
Phone
+98 21 8288 3639
Fax
+98 21 8288 3639
Email
azadfallahparviz@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Faculty of Member
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Gang Afroz street- Babol
City
Babol
Postal code
Phone
+98 11 1329 4456
Fax
+98 11 1329 4456
Email
mahbob330@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)