comparison of efficacy of metacognitive therapy and drug treatment in the frequency and severity of physical symptoms, psychological symptoms and quality of life in patients with functional dyspepsia
comparing the effect of metacognitive and medication on somatic symptoms, psychological symptoms, and quality of life in functional dyspeptic patient
Design
A randomized clinical trial study with the control group in Phase 3, including metacognitive, Nortriptyline and control groups with a sample of 65 patients. Sampling at first was available and simple random assignment was used.
Settings and conduct
65 patients with functional dyspepsia were selected during their visit to gastroenterology clinics. After filling consent form, they were randomly assigned to two groups; i.e., drug treatment with Nortriptyline 25 mg and 10 sessions metacognitive psychotherapy. Then, the patients were assessed clinically at pre-/post-treatment and a follow-up after 3 months.
Participants/Inclusion and exclusion criteria
The inclusion criteria include: Having functional dyspepsia without comorbid diseases such as IBS or other digestive diseases,
Not having a variety of chronic somatic disease,
Non simultaneous use of other psychiatric drugs,
Non dependency or abusing of substance,
Absence of severe psychiatric disorders,
Age range from 18 to 55,
Having reading and writing skills.
The exclusion criteria include: Unwillingness to participate in the research work for any reason,
The inability of the patient to access the medical center
Patients need to take any medicine other than the prescribed drugs in the study during the study.
Intervention groups
Intervention group 1: 10-session metacognitive therapy protocol based on anxiety therapy with common medical treatment in control group; Intervention Group 2: Nortriptyline, 25 mg once daily for 10 weeks along with common medical treatment in control group; Control Group: common medical treatment (25 mg omeprazole 25 mg domperidone, both once daily for 10 weeks), diet and regular exercise.
Main outcome variables
Functional dyspepsia symptoms, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190312043036N1
Registration date:2019-10-13, 1398/07/21
Registration timing:retrospective
Last update:2019-10-13, 1398/07/21
Update count:1
Registration date
2019-10-13, 1398/07/21
Registrant information
Name
Sepideh Batebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 1204
Email address
s.batebi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-22, 1398/01/02
Expected recruitment end date
2019-08-25, 1398/06/03
Actual recruitment start date
2018-02-04, 1396/11/15
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-03-06, 1397/12/15
Scientific title
comparison of efficacy of metacognitive therapy and drug treatment in the frequency and severity of physical symptoms, psychological symptoms and quality of life in patients with functional dyspepsia
Public title
effect of metacognitive therapy on patients with functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having functional dyspepsia without comorbid disease such as IBS or other digestive disease
Not having any variety of chronic somatic diseases
No simultaneous use of other psychiatric drugs
No dependency on or abusing substance
Partial adherence to diet and exercise
Absence of severe psychiatric disorders
Age range between 18 and 55
Having reading and writing skills
Exclusion criteria:
Unwillingness to participate in the research for any reason
Inability of the patient to access the medical center
Having chronic physical impairment or physical inability
Having a severe mental disorder
Substance use or dependence
Patients need to take any medicine other than the prescribed drugs in the study during the study
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the available sample was selected from those who referred to the gastroenterology clinic of Taleghani Hospital and the affiliated centers. Finally, based on the simple random sampling by throwing a dice, the outcomes 1 and 2 were considered for assigning the patients to the metacognitive therapy group, the outcomes 3 and 4 for assigning the patients to the drug treatment group and the outcomes 5 and 6 for the control group.
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
Shahid Beheshti university of medical science ethics committee
Street address
Velenjak st
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-01-16, 1396/10/26
Ethics committee reference number
IR.SBMU.MSP.REC.1396.756
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Symptoms of functional dyspepsia
Timepoint
Pre test, post test and follow up
Method of measurement
Leeds dyspepsia questionnaire and clinical interview based on Rome IV
2
Description
depression
Timepoint
Pre test, post test and follow up three months after treatment
Method of measurement
Hamilton depression questionnaire
3
Description
anxiety
Timepoint
Pre test, post test and follow up three months after treatment
Method of measurement
Hamilton anxiety questionnaire
4
Description
quality of life
Timepoint
Pre test, post test and follow up three months after treatment
Method of measurement
Nepean dyspepsia index for quality of life
Secondary outcomes
1
Description
cortisol
Timepoint
Pre test, post test and follow up three months after treatment
Method of measurement
Blood Cortisol Test
2
Description
Emotional regulation
Timepoint
Pre test, post test and follow up three months after treatment
Method of measurement
Questionnaire for difficulty in emotional regulation
3
Description
emotional processing
Timepoint
Pre test, post test and follow up three months after treatment
Method of measurement
Baker's emotional processing questionnaire
Intervention groups
1
Description
Intervention group 1: metacognitive therapy, 10-session 45-minute treatment based on the Adrian Wells protocol approach to metacognitive therapy focused on anxiety protocol; First session: Formulation; Second session: Mindfulness training; Third to sixth sessions: Working on negative metacognitive beliefs; sessions 7 and 8: Challenging Positive metacognitive beliefs; sessions 9 and 10: New processing style training and relapse prevention training with common treatment: omeprazole and domperidone 25 mg for 10 weeks, once daily (made by Sobhan company) plus adhering to recommended diet and regular exercise.
Category
Behavior
2
Description
Intervention group 2: 25 mg Nortriptyline for 10 weeks, once daily, Sobhan manufacturer with usual treatment: omeprazole and domperidone 25 mg for 10 weeks, once daily, Sobhan manufacturer, and adhering to recommended diet and regular exercise.
Category
Treatment - Drugs
3
Description
Control group: usual treatment by omeprazole and domperidone 25 mg for 10 weeks, once daily (made by Sobhan company) and adhering to recommended diet and regular exercise.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology and Liver Diseases Research Center, Shahid Beheshti University of Medical Sciences,
Full name of responsible person
Dr.Mohamad Reza Zali
Street address
Shahid Beheshti university of medical science, Velenjak st
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2521
Email
info@sbmu.ac.ir
Web page address
http://rigld.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Masjedi Arani
Street address
Arabi St. Velenjack
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
abbas masjedi arani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Arababi Street Next to Ayatollah Taleghan Hospital, Yemen St. Martyr Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
dr.abbas.masjediarani98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Masjedi Arani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Arabi st. Velenjack
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Masjedi Arani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Arabi St. Velenjack
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
results, tables and treatment protocol
When the data will become available and for how long
6 months after publication
To whom data/document is available
Qualified applicants (graduates of medical, specialty and fellowship, psychiatrists, clinical and health psychologists)
Under which criteria data/document could be used
Repeated measure analysis
From where data/document is obtainable
Sepideh Batebi
s.batebi@sbmu.ac.ir
What processes are involved for a request to access data/document
The applicants must first submit their application by an academic email to the correspondent, and then, the requests will be checked within one week and if approved the data will be sent.