The aim of the study is to determine the comparison of dialectical behavior therapy and anti-anxiety medication on anxiety symptoms of patients with functional dyspepsia
Design
In this research, 60 eligible patients with irritable bowel syndrome referring to gastrointestinal clinic were chosen purposefully and were randomly divided into three groups of interventions with behavior therapy, anti anxiety medication and control by closed packets.
Settings and conduct
This study which will be conducted in gastrointestinal clinic of Valiasr hospital birjand. patients will be divided into three groups randomly with 20 members and in the end of interventions, efficacy will be evaluated with patient assessment of upper gastrointestinal symptom (PAGI-SYM) and beck anxiety inventory.
Participants/Inclusion and exclusion criteria
Patients aged between 18 and 50 years old؛ patients who accepted to participate in the study after explaining the purposes of the study and advantages and disadvantages of the interventions؛ Patients who do not have any other anatomical or functional gastrointestinal disorders
Intervention groups
60 eligible patients with functional dyspepsia were randomly divided into three groups of interventions with behavior therapy, anti anxiety medication and control by closed packets.
Main outcome variables
Functional dyspepsia severity; Anxiety severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171022036938N2
Registration date:2018-04-16, 1397/01/27
Registration timing:registered_while_recruiting
Last update:2018-04-16, 1397/01/27
Update count:0
Registration date
2018-04-16, 1397/01/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3212 5073
Email address
dr.mas.hosseyni@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of dialectical behavior therapy and anti-anxiety medication on anxiety and symptoms of patient with functional dyspepsia
Public title
Efficacy of dialectical behavior therapy and anti-anxiety drugs on functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18 and 50 years old
Patients who accepted to participate in the study after explaining the purposes of the study and advantages and disadvantages of the interventions
There should be the possibility to keep the type and dose of the medications fixed during the study
Having at least diploma education
Exclusion criteria:
Patients who do have psychotic or other simultaneous digestive disorders
Having full criteria of personality disorders
Patients who do not have alarm signs including gastrointestinal bleeding, blood in stool, fever, weight loss, anemia, diarrhea at night, severe abdominal pain and so on
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization by sealed envelope
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 Birjand University of Medical Sciences
Street address
Faculty of medicine, Birjand University of Medical Sciences, Ghaffari street, Birjand
City
Birjand
Province
South Khorasan
Postal code
9187874151
Approval date
2017-06-25, 1396/04/04
Ethics committee reference number
Ir.bums.REC.1396.83
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
Functional dyspepsia severity
Timepoint
Before and right after the end of intervention
Method of measurement
Patient assessment of upper gastrointestinal symptom (PAGI-SYM) designed by Rentz in 2004; Made of 20 items,according to 6 degree classification 0 to 5 (no symptoms to very severe symptoms): no symptoms(0 to 20)- mild(21 to 40)- moderate(41 to 60)- sever(61 to 80)- very sever(81 to 100)
Secondary outcomes
1
Description
Anxiety severity
Timepoint
Before and right after the end of intervention
Method of measurement
Anxiety score from beck anxiety inventory
Intervention groups
1
Description
Intervention in the first intervention group:dialectical behavior therapy:an Interventional behavior therapy including discussion and practice in each meetings and also at home in order to reach mental skills, notifications and excitement control. Meetings will be held once a week, there are eight meetings,each meetings duration are 90 minutes, include aims and relative titles, discussion and practice.a first meeting is justification of dialectical behavior therapy for participants and each next meetings are based on a five minutes mental practice and comprehensive notice by breathing and then review the previous meetings. Patient assessment of upper gastrointestinal symptom (PAGI-SYM) designed by Rentz in 2004; Made of 20 items,according to 6 degree classification 0 to 5 (no symptoms to very severe symptoms)
Category
Behavior
2
Description
Intervention in the second intervention group: Anti-anxiety treatment: Sertraline, 100 mg orally once a day for eight weeks
Category
Treatment - Drugs
3
Description
Control group: Symptomatic treatment with pantoprazole 40 mg orally daily for eight weeks