Protocol summary
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Study aim
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comparing the effect of metacognitive and medication on somatic symptoms, psychological symptoms, and quality of life in functional dyspeptic patient
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Design
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A randomized clinical trial study with the control group in Phase 3, including metacognitive, Nortriptyline and control groups with a sample of 160 patients. Sampling at first was available and simple random assignment was used.
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Settings and conduct
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160 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, 6 months.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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 (20 mg omeprazole 10 mg domperidone, both once daily for 10 weeks), diet and regular exercise.
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Main outcome variables
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Functional dyspepsia symptoms, quality of life
General information
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Reason for update
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the extension of study in order to the sample size and extended follow-ups.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190312043036N1
Registration date:
2019-10-13, 1398/07/21
Registration timing:
retrospective
Last update:
2020-01-28, 1398/11/08
Update count:
1
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Registration date
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2019-10-13, 1398/07/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-22, 1398/01/02
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Expected recruitment end date
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2019-08-25, 1398/06/03
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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effect of metacognitive therapy on patients with functional dyspepsia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 55 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
160
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-16, 1396/10/26
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Ethics committee reference number
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IR.SBMU.MSP.REC.1396.756
Health conditions studied
1
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Description of health condition studied
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Functional dyspepsia
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ICD-10 code
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K30
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ICD-10 code description
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Functional dyspepsia
Primary outcomes
1
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Description
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Symptoms of functional dyspepsia
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Timepoint
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Pre test, post test and follow up
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Method of measurement
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Leeds dyspepsia questionnaire and clinical interview based on Rome IV
2
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Description
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depression
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Timepoint
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Pre test, post test and follow up three months after treatment
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Method of measurement
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Hamilton depression questionnaire
3
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Description
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anxiety
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Timepoint
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Pre test, post test and follow up three months after treatment
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Method of measurement
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Hamilton anxiety questionnaire
4
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Description
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quality of life
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Timepoint
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Pre test, post test and follow up three months after treatment
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Method of measurement
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Nepean dyspepsia index for quality of life
Secondary outcomes
1
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Description
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cortisol
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Timepoint
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Pre test, post test and follow up three months after treatment
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Method of measurement
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Blood Cortisol Test
2
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Description
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Emotional regulation
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Timepoint
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Pre test, post test and follow up three months after treatment
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Method of measurement
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Questionnaire for difficulty in emotional regulation
3
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Description
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emotional processing
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Timepoint
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Pre test, post test and follow up three months after treatment
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Method of measurement
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Baker's emotional processing questionnaire
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Intervention group 2: 25 mg Nortriptyline for 10 weeks, once daily, Sobhan manufacturer with usual treatment: omeprazole 20 mg and domperidone 10 mg for 10 weeks, once daily, Sobhan manufacturer, and adhering to recommended diet and regular exercise.
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Category
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Treatment - Drugs
3
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Description
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Control group: usual treatment by omeprazole (20 mg, once daily, Sobhan Darou) and domperidone ( motidon, 10 mg, once daily, Abidi co.) for 10 weeks, and recommended diet and regular exercise.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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results, tables and treatment protocol
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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Qualified applicants (graduates of medical, specialty and fellowship, psychiatrists, clinical and health psychologists)
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Under which criteria data/document could be used
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Repeated measure analysis
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From where data/document is obtainable
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Sepideh Batebi
s.batebi@sbmu.ac.ir
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What processes are involved for a request to access data/document
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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.
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Comments
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