Protocol summary
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Study aim
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Combined effect of recurrent transcranial magnetic stimulation of the brain With cognitive-behavioral therapy in patients with panic disorder
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Design
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A randomized, double-blind, randomized controlled clinical trial of 45 patients
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Settings and conduct
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This study will be performed in Beheshti hospital clinic with repeated transcranial magnetic stimulation for 20 session and cognitive-behavioral therapy for 12 sessions.
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Participants/Inclusion and exclusion criteria
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Having complete diagnostic criteria for panic disorder at the discretion of a Psychiatrist and psychologist based on diagnostic and statistical manual of Mental disorder , being 18 to 65 years old, the participants needed to Complete the written consent form, Do not use alcohol and substances during The last month. Exclusion criteria: Inclusion complete criteria for personality Disorder, Existence of psychotic disorders, bipolar, history of epilepsy and Seizures, Use of tricyclic antidepressants (TCAs).
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Intervention groups
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The first intervention group will receive a combination of repetitive transcranial magnetic stimulation of the brain(rTMS) and cognitive-behavioral therapy(CBT). The second intervention group will receive only
rTMS, and finally the control group will receive sham rTMS with CBT.
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Main outcome variables
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Clinical signs of panic disorder, emotional regulation, attention bias, depression, amplitude and coherence, and asymmetry in the frontal cortex of people with panic.
General information
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Reason for update
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Due to the registration of the project with the following scientific title in Zanjan University of Medical Sciences, the title was changed
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210611051543N1
Registration date:
2021-08-05, 1400/05/14
Registration timing:
registered_while_recruiting
Last update:
2021-08-07, 1400/05/16
Update count:
1
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Registration date
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2021-08-05, 1400/05/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-07-13, 1400/04/22
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Expected recruitment end date
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2022-01-12, 1400/10/22
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Synergistic effect of repeated transcranial magnetic stimulation with cognitive behavioral therapy in patients with panic disorder
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Public title
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The synergistic effect of repeated transcranial magnetic stimulation of the brain with cognitive behavior therapy in patients with panic disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having diagnostic criteria for Panic disorder based on psychiatrist diagnosis and clinical interview
Having at least a third secondary education
Experience at least 3 panic attacks per week
Being 18 to 65 years old
Signing the written consent form
Not to be exposed to any psychological Therapies for at least 1 month before entering the research
Not using alcohol and substances during the last month
Exclusion criteria:
Inclusion complete criteria for personality disorder
Existence of psychotic disorders, bipolar
History of epilepsy and seizures
No contraindications to repeated transcranial magnetic Stimulation, such as metal in the head or implanted brain medical Devices
Diagnosis of any neurological conditions affecting central Nervous system(e.g. Parkinson's disease)
Pregnancy
Use of tricyclic antidepressants (TCAs)
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, we will use the finite randomization method of block randomization. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all blocks is equal and in this three-group experiment we will have 15 blocks (including 5 people in the first intervention group, 5 people in the second intervention group and 5 people in the control group). Randomization tool also uses random sequence generation software that these random sequence generation software in addition to simple structural randomization are able to generate random sequence by blocking method. For concealment, we use random allocation concealment, which is the method used to execute random sequences on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants to the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The subjects do not know the type of intervention.
The patient receives the intervention in separate coded treatment rooms.
No mirrors are installed on the patient's entrance and exit.
Coding is done by one of the design partners.
Patients do not see each other during the intervention.
People who analyze the results do not know the nature of the study groups.
The evaluation is done by someone other than the researcher.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-05-25, 1400/03/04
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Ethics committee reference number
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IR.ZUMS.REC.1400.060
Health conditions studied
1
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Description of health condition studied
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Panic disorder
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ICD-10 code
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F41.0
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ICD-10 code description
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Panic disorder [episodic paroxysmal anxiety] without agoraphobia
Primary outcomes
1
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Description
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Percentage of people whose Panic Disorder Severity Scale score is above 4
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Timepoint
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Measurement of panic before intervention, in the tenth session of the intervention, after the intervention, follow-up for two months after the intervention
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Method of measurement
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Panic Disorder Severity Scale
2
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Description
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Percentage of people whose Beck questionnaire score is above 20
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Timepoint
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Measurement of depression before the intervention, after intervention, tow-month follow-up intervention
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Method of measurement
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Beck Questionnaire
3
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Description
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Percentage of people whose Hamilton questionnaire score is above 17
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Timepoint
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Measurement of depression before the intervention, after intervention and tow-month follow-up intervention
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Method of measurement
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Hamilton Depression Test
4
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Description
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Cognitive test score in Stroop test
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Timepoint
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Measurement of attention bias before intervention, after intervention and tow-month follow-up after intervention
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Method of measurement
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Stroop test
5
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Description
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Analyze the electroencephalography results
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Timepoint
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Measurements before the intervention, after the intervention
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Method of measurement
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Electroencephalography
Secondary outcomes
1
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Description
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The higher the score, the higher the emotion regulation
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Timepoint
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Measuring emotion regulation strategies before intervention, after intervention and follow-up for tow months after intervention
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Method of measurement
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Gross and John Emotion Regulation Questionnaire
Intervention groups
1
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Description
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Intervention group: The combination of repetitive transcranial magnetic stimulation of the brain and cognitive-behavioral therapy؛ The first session of cognitive-behavioral therapy, includes assessment and homework; session 2: assessment, socialization to treatment, medication and homework, session 3: assessment, interventions, medication and homework, session 4 includes assessment, behavioral interventions, medication and homework; sessions 5-8 include assessment, cognitive interventions, other interventions, medication and homework, sessions 9-10 include assessment, cognitive interventions, behavioral interventions, medication, and homework; sessions 11-12 include assessment, cognitive interventions, behavioral interventions, other interventions, and homework. Repetitive transcranial magnetic stimulation protocol: 1 Hz transcranial magnetic stimulation to stimulate the right dorsolateral prefrontal cortex, 110% resting motor threshold, 1800 pulses (lasting for 30 minutes) in each session, and one session per day. Performed for 20 sessions (5 sessions per week for 4 weeks).
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Category
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Treatment - Devices
2
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Description
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Intervention group: Repetitive transcranial magnetic stimulation: 1 Hz transcranial magnetic stimulation to stimulate the right dorsolateral prefrontal cortex, 110% resting motor threshold, 1800 pulses (lasting for 30 minutes) in each session, and one session per day. Performed for 20 sessions (5 sessions per week for 4 weeks).
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Category
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Treatment - Devices
3
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Description
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Control group: The control group received sham repetitive transcranial magnetic stimulation. Most of the parameters of the sham stimulation (frequency, pulses, stimulation site and intensity) were the same as for active stimulation. The sham stimulation was defined with a coil diverted by90 degrees over the same area and same intensity and design as real repetitive transcranial magnetic stimulation. An also cognitive-behavioral therapy applied in this group.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Outcomes and results are published in the form of statistics
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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The data will be available to researchers
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Under which criteria data/document could be used
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Can be used for secondary studies
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From where data/document is obtainable
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93Ma.hbi@zums.ac.ir 09147432754
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What processes are involved for a request to access data/document
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Will be sent after receiving the email
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Comments
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