This study evaluates de efficacy of Theta Burst Transcranial Magnetic Stimulation (TMS) applied on the left dorsolateral prefrontal cortex in patients with Major Depressive disorder and tobacco consumption.
Major Depressive Disorder (MDD) affects 350 million worldwide causing damage on quality of life and risk behavior such as suicide and smoking. smoking is the second leading cause of death causing about 5 million deaths annually. Theta Burst Stimulation (TBS) is a more tolerable protocol administered at lower intensities and shorter intervals than conventional rTMS protocols.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill
Sofia Cañizares Gómez
Querétaro City, Querétaro, Mexico
RECRUITINGMINI Neuropsychiatric Interview
It is a short structured diagnostic interview that explores the main psychiatric disorders of Axis I of DSM-IV and ICD-10
Time frame: 15 minutes
Fagerström test
it is a short and simple test consisting of 6 questions. The score ranges from 0-10, so that the higher the score, the greater the dependency. Not only does this test measure physical dependence but it also has therapeutic and prognostic value.
Time frame: 5 minutes
Richmond Test
Scale consisting of 4 items to assess the degree of motivation to quit smoking on a scale of 1 to 10. For an individual to have expectations of success in a smoking cessation program, they must present a score of 9 or 10 points
Time frame: 5 minutes
Glover-Nilsson Test
Test consisting of 11 items to measure the psychosocial and behavioral dependence of individuals; it is scored from 0 to 4, with 4 being the maximum score, items 1,4 and 5 measure psychological dependence, questions 2,3,6,7,8,9 and 10 measure behavioral dependence and question 11 measures social dependence.
Time frame: 8 minutes
Test of the Unit of the Institute of Public Health of Madrid (UISPM)
Test consisting of 23 items divided into 6 modules (stimulation, sedation, automatism, social dependency, psychic dependency and gestural dependency) each item is scored from 0 to 4 being 4 the highest score.
Time frame: 10 minutes
Minnesota Nicotine Withdrawal Syndrome Scale (MNWS)
This eight-item scale measures withdrawal symptoms (craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia), The score ranges from 0 to 4, with 4 being the highest score, indicating a severe withdrawal syndrome
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Time frame: 5 minutes
Nicotine Craving Questionnaire (CCN)
12-item questionnaire to assess the degree of craving, with five response options ranging from completely disagree 1 to completely agree 5
Time frame: 8 minutes
Paradigm of reactivity to signals and heart rate variability
it consists of presenting a series of images that were chosen from the International Series of images for smoking (with neutral counterparts), Version 1.2 (58), the images were presented as follows : 2 blocks of smoking images and 2 blocks with neutral images that are interspersed, each block contains 25 images with a duration of 6 seconds per image, the test has a total duration of 10 minutes; while the participant observes the images, they will place a polar model H10 bluetooh chest strap sensor to measure HRV
Time frame: 10 minutes
Co-oximetry
spectrophotometric technique to detect the loss in the oxygenation capacity of hemoglobin that consists of determining the level of carbon monoxide (CO) in the air exhaled by an individual, levels of 10 or more ppm of CO in the exhaled air correspond to smoking subjects. Levels of 6 to 10 ppm in sporadic smokers, and figures below 6 ppm in non-smokers.
Time frame: 1 minute
Hamilton Rating Depression Scale (HDRS)
21 item, Clinical assessment of depressive symptoms
Time frame: 10 minutes
Montgomery-Asberg Rating Depression Scale (MADRS)
10 ítem Clinical assessment of the principal depressive symptoms
Time frame: 10 minutes
Hamilton Anxiety Rating Scale (HARS)
14 Ítem clinical scale for rating anxiety symptoms.
Time frame: 10 minutes
Beck Depression Invetory (BDI)
it´s a 21 ítem self evaluated symptomatology of depression
Time frame: 10 minutes
Beck Hopelesness Scale (BHS)
is a 20-item self-report inventory designed to measure 3 major aspects of hopelessness (Feelings about the future, loss of self-motivation and expectations)
Time frame: 10 minutes
Plutchik Risk Suicide Scale
it´s a 26 ítem self-reported scale that assess the intensity of suicidal ideation
Time frame: 10 minutes
Beck suicidal ideation scale (BSIS)
is an evaluation of suicidal thinking: is an evaluation of suicidal thinking that helps identify individuals at risk of comitting self harm
Time frame: 10 minutes
Wisconsin Card Sorting Test (WCST)
is a neuropsychological test that assess cognitive flexibility
Time frame: 20 minutes
Stop Signal Task
is a unique versión of a classic approach to measuring response inhibition
Time frame: 25 minutes
Marlowe and Crowne Social Desirability Scale
self-applied scale consisting of 33 items for the evaluation of the need for social approval, for example, generating a good impression through socially appropriate responses
Time frame: 10 minutes