Comparison of the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) and Mindfulness-Based Cognitive Therapy (MBCT) on Transdiagnostic Variables; Rumination, Worry and Neuropsychological Functions in Depressed Patients.
Comparison of the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) and Mindfulness-Based Cognitive Therapy (MBCT) on Depression treatment
Design
Clinical trial with Non-randomized Sampling without blinding, Total sample size 45 subjects in 2 intervention groups and 1 control group.
Settings and conduct
Intervention group 1 received 8 Online Sessions Mindfulness-Based Cognitive group Therapy.
Intervention group 2 received 20 Sessions Repetitive Transcranial Magnetic Stimulation with Depression protocol therapy in Center of Atiye Derakhshan Zehn.
Control group didn't receive intervention until the end of assessments.
Participants/Inclusion and exclusion criteria
Having score above 20 in Beck Depression Inventory؛ Having history of seizure, head truma, Bipolar disorders, Psychotic disorders and having any metal in body
Intervention groups
Intervention group 1: 8 Sessions Mindfulness-Based Cognitive group Therapy (MBCT)
Intervention group 2: 20 Sessions Repetitive Transcranial Magnetic Stimulation (rTMS)
Control group: No treatment
Main outcome variables
Rumination Score in Youssefi Rumination Inventory; Meta Worry Score in the Wells Anxious Thoughts Inventory; Neuropsycholigical Functions Scores in Cambridge Neuropsychological Test Automated Battery (CANTAB)
General information
Reason for update
Acronym
rTMS- MBCT
IRCT registration information
IRCT registration number:IRCT20190831044652N1
Registration date:2019-10-06, 1398/07/14
Registration timing:retrospective
Last update:2019-10-06, 1398/07/14
Update count:0
Registration date
2019-10-06, 1398/07/14
Registrant information
Name
Mahboobeh Majdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7734 1880
Email address
mahboobeh.majdi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-21, 1397/06/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
2018-09-21, 1397/06/30
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2019-04-21, 1398/02/01
Scientific title
Comparison of the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) and Mindfulness-Based Cognitive Therapy (MBCT) on Transdiagnostic Variables; Rumination, Worry and Neuropsychological Functions in Depressed Patients.
Public title
Effect of rTMS and MBCT in treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of Depressed Patients above 20 in Beck Depression Inventory
Exclusion criteria:
Having history of Head Truma
Having history of Bipolar Disorder
Having history of Psychotic Disorders
Drug Dependency
Being Pregnant
Having prosthesis
Having any kind of Metal in Body
Having Pace Maker
Having history of Seizure in family
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
3 Group in study; 2 of them having different interventions and 1 control group with no intervention
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Behshti University of Medical Sciences
Street address
Medical school, Shahid Behshti University of Medical Sciences, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
193954719
Approval date
2018-04-10, 1397/01/21
Ethics committee reference number
IR.SBMU.MSP.REC.1397.95
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Rumination Score in Youssefi Rumination Inventory
Timepoint
Measuring Rumination before and after treatment and three months later
Method of measurement
Youssefi Rumination Inventory
2
Description
Meta Worry Score in the Wells Anxious Thoughts Inventory
Timepoint
Measuring Meta Worry before and after treatment and three months later
Method of measurement
Wells Anxious Thoughts Inventory
3
Description
Neuropsycholigical Functions Scores in Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint
Measuring Neuropsycholigical Functions before and after treatment and three months later
Method of measurement
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Secondary outcomes
1
Description
Depression Score
Timepoint
Measuring Depression before and after treatment and 3 month later
Method of measurement
Beck Depression Inventory
Intervention groups
1
Description
Intervention group 1: 8 session Mindfulness-Based Cognitive group therapy
Category
Behavior
2
Description
Intervention group 2: 20 Sessions Repetitive Transcranial Magnetic Stimulation (rTMS)