Comparison of the Effectiveness of repetitive Transcranial Magnetic Stimulation(rTMS) and Cognitive-Behavioral Therapy(CBT) on Symptoms of obsessive-compulsive disorder, Symptoms of Depression, Cognitive Flexibility, and Working Memory in People with Obsessive-Compulsive Disorder
Comparison of the effectiveness of Transcranial Magnetic Stimulation and Cognitive-Behavioral Therapy on symptoms of obsessive-compulsive disorder, Symptoms of Depression, Cognitive Flexibility, and Working Memory in People with Obsessive-Compulsive Disorder
Design
Randomized controlled trial with 2 interventional groups with parallel groups on 30 patients that will be randomly assigned into two groups. ( 15 members for each one)
Settings and conduct
30 patients will be selected from who refer to the psychiatric clinic of Beheshti hospital of Zanjan and they will be divided in 2 groups randomly. After obtaining informed consent to participate in the research, the Yale-Brown Obsessive, Compulsive Scale the Hamilton Depression Rating Scale, The cognitive flexibility inventory, the n-back task will be done. The questionnaires and re-evaluation tests, will be repeated after intervention as post test and one month follow up. The patient will be evaluated by someone other than the therapist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Full diagnostic criteria for obsessive–compulsive disorder based on DSM-5 ; No previous psychological treatment; No previous transcranial direct current stimulation and neurofeedback interventions. Exclusion criteria: Personality disorders; Psychotic disorders; Past history of seizures and epilepsy ; Electrical or Metal object in the body
Intervention groups
Intervention Group 1: Cognitive-Behavioral Therapy: Treatment sessions are performed in 18-20 sessions (each session approximately 45-90 minutes twice a week ) ; Intervention group2: Each person receives repetitive transcranial magnetic stimulation with a frequency of 1 Hz, over the right dorsolateral prefrontal cortex five times a week for two weeks
Main outcome variables
Symptoms of obsessive-compulsive disorder, Symptoms of Depression, Cognitive Flexibility, Working Memory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200805048316N1
Registration date:2020-11-05, 1399/08/15
Registration timing:registered_while_recruiting
Last update:2020-11-05, 1399/08/15
Update count:0
Registration date
2020-11-05, 1399/08/15
Registrant information
Name
arash fazeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 5256
Email address
fazeliarash@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-04, 1399/08/14
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of repetitive Transcranial Magnetic Stimulation(rTMS) and Cognitive-Behavioral Therapy(CBT) on Symptoms of obsessive-compulsive disorder, Symptoms of Depression, Cognitive Flexibility, and Working Memory in People with Obsessive-Compulsive Disorder
Public title
Comparison of the effectiveness of transcranial magnetic stimulation and cognitive-behavioral therapy in improving people with obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Full diagnostic criteria for obsessive-compulsive disorder by diagnosis of a psychiatrist and psychologist based on DSM-5
Intermediate school Degree
Signing a written consent
No previous psychological treatment
No previous Transcranial Direct-Current Stimulation (tdcs) and neurofeedback interventions
Exclusion criteria:
Risk of suicide
Personality disorder
Psychotic disorders
Seizures and epilepsy records
The presence of an electrical or metal object in the body
Bipolar disorder
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
First of all each sample is given a specific code, then each code is written on a piece of paper and the papers are poured into a container. According to the sample size in each groups, a few papers will be randomly drawn.
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 committe of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Approval date
2020-08-04, 1399/05/14
Ethics committee reference number
IR.ZUMS.REC.1399.180
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Symptoms of obsessive-compulsive disorder
Timepoint
Before intervention, After the intervention, One month after the intervention
Method of measurement
Yale Brown Obsessive-Compulsive Scale questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
Before intervention, After the intervention, One month after the intervention
Method of measurement
Hamilton Derepssion Rating Scale
2
Description
Working memory
Timepoint
Before intervention, After the intervention, One month after the intervention
Method of measurement
N-Back task
3
Description
Cognitive flexibility
Timepoint
Before intervention, After the intervention, One month after the intervention
Method of measurement
Cognitive flexibility questionnaire
Intervention groups
1
Description
Intervention Group 1: Cognitive-Behavioral Therapy: Treatment for 18-20 sessions (each session approximately 45-90 minutes twice a week ) according to the protocol (Leahy,2012); Sessions 1–2: Assess presenting problem; Inquire regarding all symptoms; Assess presence of obsessions and compulsions; Assess avoidance behaviors; Assess feared consequences; Assess internal and external triggers of obsessional anxiety; Assess impairment in social, educational, and occupational functioning; Inform patient of diagnosis and provide education on Obsessive–compulsive disorder(OCD); Educate patient regarding treatment options, including medication; Sessions 3–4: Evaluate homework; Review all obsessions, compulsions, and avoided situations; Assess motivation for treatment; Build motivation; Describe cognitive-behavioral conceptualization of OCD and describe cognitive-behavioral treatment; Obtain patient’s commitment to proceed with treatment; Introduce cognitive model; Identify automatic thoughts, obsessional anxiety, compulsions or urge to ritualize, and triggering situations; Evaluate automatic thoughts; Sessions 5–6: Evaluate homework; Re- administer self-report questionnaires to assess mood and track progress; Educate patient regarding intrusive thoughts as normal phenomena; Evaluate validity of automatic thoughts; Help patient devise behavioral experiments; Sessions 7–10: Continue modifying automatic thoughts, dysfunctional assumptions; Continue helping patient devise behavioral experiments; Help patient complete exposure hierarchies; Plan initial exposure sessions; Conduct exposure to initial items on hierarchies of obsessions and avoided situations; Teach postponing, slowing, and changing repetitions; Sessions 11–16: Examine and challenge any thoughts related to avoidance of exposure; Examine and challenge any thoughts related to lapses in rituals; Complete exposure to items higher up hierarchies of obsessions and avoided situations; Continue to help patient block rituals; Examine any lapses in response prevention; Sessions 17–20: Assess attainment of goals to determine whether treatment may be tapered; Track progress in identifying and modifying thoughts; Assess any life problems related to OCD or patient improvement; Ensure that exposure is being performed to items highest on the hierarchy; Monitor any lapses
Category
Treatment - Other
2
Description
Intervention group2: Each person receives repetitive transcranial magnetic stimulation (rTMS) with a frequency of 1 Hz, four attempts per session, and 500 pulses each time over the right dorsolateral prefrontal cortex(rDLPFC). And receive a total of 2000 pulses per session. The sessions will be performed five times a week for two weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohsen Dadashi
Street address
Beheshti hospital, Ark sq; zanjan
City
Zanjan
Province
Zanjan
Postal code
۱۵۷۸۸-۴۵۱۳۶
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
mohsendadashi@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=29
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shogli
Street address
Zanjan University of Medical Sciences, Azadi BLVD, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3342 0651
Fax
+98 24 3354 2403
Email
mohsendadashi@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=1
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 2403
Email
mohsendadashi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Arash Fazeli
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
Zanjan
Province
Zanjan
Postal code
15788-45136
Phone
+98 24 3354 2403
Email
fazeliarash@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Arash Fazeli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
Zanjan
Province
Zanjan
Postal code
15788-45136
Phone
+98 24 3354 2403
Email
fazeliarash@zums.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Total data after unidentifiable people as SPSS can be shared.
When the data will become available and for how long
Six months later print the results.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
researchers in academic and scientific institutions
From where data/document is obtainable
DR. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Mohsen Dadashi, Mobile: 0098 9127433559. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology,Arash Fazeli, Mobile: 0098 9178661215
What processes are involved for a request to access data/document
Documents will be shared only when the reason for the request is announced by phone or e-mail