Title: Effectiveness of Mindfulness-Based Stress Reduction (MBSR) Intervention on Psychological Symptoms, Quality of Life, Symptom Severity in Patients with Somatic Symptoms Disorder
Determining the effectiveness of mindfulness-based stress reduction intervention on psychological symptoms, quality of life, symptom severity in patients with somatic symptoms disorder
Design
The present study is a randomized clinical trial with control group.
Settings and conduct
Patients with impaired physical symptoms referred to Shariati Clinic and Noor Hospital of Isfahan University of Medical Sciences were interviewed by a psychiatrist.The patients in case of having inclusion and exclusion criteria and announcing consent to participate in the study are divided into two groups (Mindfulness-Based Stress Reduction Intervention or control) based on random numbers table. Both groups will receive 37.5-150 mg of venlafaxine for 8 weeks, and the intervention group will receive 8 sessions of psychotherapy to review physical stress symptoms, stress reduction techniques, and attention to everyday life events. Both groups complete the stress, anxiety and depression questionnaire, quality of life questionnaire, and Patient Health Questionnaire Physical Symptom before the study and 8 weeks later.
Participants/Inclusion and exclusion criteria
Diagnosis of somatic symptoms disorder based on diagnostic psychiatric criteria
Having a minimum of elementary education
Age between 20 to 50 years
Have no history of suicide
Has not received psychotherapy in the last 6 months
Not have a major psychiatric disorder based on a psychiatric interview
Intervention groups
MBSR Group In addition to venlafaxine 37.5-150 mg, receive 8 sessions of psychotherapy to monitor the symptoms of physical stress, stress reduction methods, and attention to everyday life events. The control group received only 37.5-150 mg of venlafaxine.
Main outcome variables
Anxiety, Depression, Physical symptoms, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040974N2
Registration date:2020-08-01, 1399/05/11
Registration timing:registered_while_recruiting
Last update:2020-08-01, 1399/05/11
Update count:0
Registration date
2020-08-01, 1399/05/11
Registrant information
Name
Fatemeh Zargar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
f.zargar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-06, 1399/03/17
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title: Effectiveness of Mindfulness-Based Stress Reduction (MBSR) Intervention on Psychological Symptoms, Quality of Life, Symptom Severity in Patients with Somatic Symptoms Disorder
Public title
Mindfulness-Based Stress Reduction in Somatic symptom disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Documented diagnosis of Somatic Symptom Disorder based on Diagnostic and Statistical Manual of psychiatric disorders
Educational level more than primary school,
Age between 20-50 years,
Patient's willingness to participate in this study
Exclusion criteria:
Diagnosis of other major psychiatry disorder based on clinical interview and
Substance use disorder
Participating in another psychotherapy
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
First, eligible patients will be simple randomly selected. Then they will be divided into two groups using random numbers created by computer software (SPSS software). So that, even numbers will be in the intervention group and odd numbers will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst is unaware of the group membership of the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Department of Health Psychology, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.MUI.REC.1397.3.107
Health conditions studied
1
Description of health condition studied
somatic symptom disorder
ICD-10 code
F40.232
ICD-10 code description
Fear of other medical care
Primary outcomes
1
Description
Anxiety
Timepoint
Before and 8 weeks after intervention
Method of measurement
Questionnaire of anxiety, depression, stress scale (DASS)
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and 8 weeks after the intervention
Method of measurement
36-Item Short Form Health Survey
2
Description
Clinical symptoms
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Patient Health Questionnare 15-item
Intervention groups
1
Description
Intervention group: The intervention group was treated with Venlafaxine, and they participated in eight 2-hour sessions of the Mindfulness Based Stress Reduction (MBSRD) program on a weekly basis. Venlafa xine was prescribed 37.5 to 150 mg daily for 8 weeks (VenabidER®, ABIDI Company, Tehran, Iran).
Category
Behavior
2
Description
Control group: the control group was treated with Venlafaxine alone. Venlafaxine was prescribed 37.5 to 150 mg daily for 8 weeks (Venabid ER®, ABIDI Company, Tehran, Iran).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Hospital
Full name of responsible person
Leila Rahafrouz
Street address
Isfahan University of Medical Sciences, Department of Health Psychology, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8109
Email
fatemehzargar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8109
Email
mortazavi@gmail.om
Grant name
Isfahan University of Medical Sciences Vice Chancellor for Research
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Leila Rahafrouz
Position
Non-Faculty Physician
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isfahan University of Medical Sciences, Department of Health Psychology, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8109
Email
fatemehzargar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Rahafrouz
Position
Non- Faculty Physician
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isfahan University of Medical Sciences, Department of Health Psychology, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8109
Email
fatemehzargar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Rahafrouz
Position
Non- Faculty Physician
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isfahan University of Medical Sciences, Department of Health Psychology, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8109
Email
fatemehzargar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
specific participant data sets related to primary outcome measure are to be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Therapists working in hospital clinics
From where data/document is obtainable
Email: fatemehzargar@gmail.com
What processes are involved for a request to access data/document