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IRCT20200805048316N1 IRCT 2020-11-05 Zanjan University of Medical Sciences Comparison of the effectiveness of transcranial magnetic stimulation and cognitive-behavioral therapy in improving people with obsessive-compulsive disorder 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 2020-11-04 anticipated 30 Complete https://irct.ir/trial/50734 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Obsessive-compulsive disorder. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Total data after unidentifiable people as SPSS can be shared. When: Six months later print the results. To whom: Researchers working in academic and scientific institutions Conditions: researchers in academic and scientific institutions Where to obtain: 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 How to obtain: Documents will be shared only when the reason for the request is announced by phone or e-mail Comments:
public Mohsen Dadashi
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
Zanjan Iran (Islamic Republic of) 45136-15788 +98 24 3354 2403 mohsendadashi@zums.ac.ir Zanjan University of Medical Sciences scientific Arash Fazeli
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
Zanjan Iran (Islamic Republic of) 15788-45136 +98 24 3354 2403 fazeliarash@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 50 years Both Risk of suicide Personality disorder Psychotic disorders Seizures and epilepsy records The presence of an electrical or metal object in the body Bipolar disorder F42 Obsessive-compulsive disorder Treatment - Other Treatment - Devices 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 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. 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. Depression. Timepoint: Before intervention, After the intervention, One month after the intervention. Method of measurement: Hamilton Derepssion Rating Scale. Working memory. Timepoint: Before intervention, After the intervention, One month after the intervention. Method of measurement: N-Back task. Cognitive flexibility. Timepoint: Before intervention, After the intervention, One month after the intervention. Method of measurement: Cognitive flexibility questionnaire. Zanjan University of Medical Sciences Approved 2020-08-04 Ethics committe of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Azadi Square, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)