Addictions are among the most serious and expensive public health problems in Europe and Spain and they present high morbimortality. There is an increasing amount of studies emphasizing the role e-health for improving current treatments in mental health but research in addictions is still scarce. Over the last years, there have been several indicators that show an upward trend in the consumption of cocaine and the highly treatment-resistant patients. Objectives: 1) To evaluate whether adding a web-based cognitive behavioral therapy (CBT4CBT) to standard cocaine use disorder treatment improves treatment outcomes in a Spanish sample of patients with severe addiction 2) To explore differences between men and women in treatment response and psychopathological risk factors of treatment response. Design: Randomized clinical trial. Selection criteria: patients consecutively admitted to the inpatient treatment unit for cocaine detoxification and meet inclusion criteria. Sample: the total sample will be of 70 individuals (randomly assigned to TAU + web-based CBT4CBT (n=35) or to TAU (n=35)). Assessment: Patients will be assessed at the beginning and during inpatient treatment, before and during outpatient treatment (CBT4CBT or TAU), after outpatient treatment (CBT4CBT or TAU) and at follow ups. Treatment retention, changes on craving and related psychological variables as well as presence of benzoylecgonine in urine will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Cognitive behavioral treatment through the web CBT4CBT
Hospital Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGRelapse
Change from baseline at 14 days of inpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine after hospitalization and before starting Arm 1 or 2.
Time frame: Through hospitalization completion, an average of 14 days
Relapse
Change from baseline at 8 weeks of outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine during the 8-week period of Arm 1 or 2.
Time frame: Through the 8-week period of arm 1 or 2.
Relapse
Change from baseline at 1 month after outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine at follow-up time point.
Time frame: At 1 month follow-up after Arm 1 or 2
Relapse
Change from baseline at 3 months after outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine at follow-up time point.
Time frame: At 3 months follow-up after Arm 1 or 2
Relapse
5\. Change from baseline at 6 months after outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine at follow-up timepoint.
Time frame: At 6 months follow-up after Arm 1 or 2
Treatment retention
Change from baseline at 14 days of inpatient treatment, after hospitalization and before starting Arm 1 or 2.
Time frame: Through hospitalization completion, an average of 14 days
Treatment retention
Change from baseline at 8 weeks of outpatient treatment during the 8-week period of Arm 1 or 2.
Time frame: Through the 8-week period of arm 1 or 2
Treatment retention
Change from baseline at 1 month after outpatient treatment.
Time frame: At 1 month follow-up after completing Arm 1 or 2
Treatment retention
Change from baseline at 3 months after outpatient treatment.
Time frame: At 3 months follow-up after completing Arm 1 or 2
Treatment retention
Change from baseline treatment retention versus drop out at 6 months after treatment at follow-up time point.
Time frame: At 6 months follow-up after completing Arm 1 or 2
Psychopathology, dependence and craving, as well as anthropometric measures
* MINI international neuropsychiatric interview * Symptom CheckList-90 items-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom. * The State-Trait Anxiety Inventory. Every sub-scale has a total score, ranging from 20 to 80, with higher scores correlating with greater anxiety. * Beck's Depression Inventory. The total score ranges from 0 to 63, with higher scores indicating a greater severity of the symptoms. * Severity of Dependence Scale. The total score ranges from 0 to 15, with a higher score indicating grater dependence. * Cocaine Selective Severity Assessment. The scale has a total score ranging from 0 to 126, where a higher score indicates more severity of the withdrawal symptoms. * Weiss Cocaine Craving Scale. The total score ranges from 0 to 45, where a higher score indicates more severity of craving symptomatology. * Weight is measured in kilograms (Kg) * Heigh is measured in meters (m)
Time frame: At baseline, at the beginning of hospitalization
Psychopathology, dependence and craving, as well as anthropometric measures
* Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom. * The State-Trait Anxiety Inventory. Every sub-scale has a total score, ranging from 20 to 80, with higher scores correlating with greater anxiety. * Beck's Depression Inventory. This instrument has a total score ranging from 0 to 63, with higher scores indicating a greater severity of the symptoms. * Severity of Dependence Scale. This questionnaire provides a total score ranging from 0 to 15, with a higher score indicating grater dependence. * Cocaine Selective Severity Assessment. The scale has a total score ranging from 0 to 126, where a higher score indicates more severity of the withdrawal symptoms. * Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology. * Weight is measured in kilograms (Kg) * Heigh is measured in meters (m)
Time frame: At hospitalization completion, an average of 14 days
Psychopathology, dependence and craving, as well as anthropometric measures
* Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom. * The State-Trait Anxiety Inventory. Every sub-scale has a total score, ranging from 20 to 80, with higher scores correlating with greater anxiety. * Beck's Depression Inventory. This instrument has a total score ranging from 0 to 63, with higher scores indicating a greater severity of the symptoms. * Severity of Dependence Scale. This questionnaire provides a total score ranging from 0 to 15, with a higher score indicating grater dependence. * Cocaine Selective Severity Assessment. The scale has a total score ranging from 0 to 126, where a higher score indicates more severity of the withdrawal symptoms. * Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology. * Weight is measured in kilograms (Kg) * Heigh is measured in meters (m)
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Time frame: Once the 8-week outpatient treatment is completed
Psychopathology, dependence and craving, as well as anthropometric measures
* Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom. * Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology. * Weight is measured in kilograms (Kg) * Heigh is measured in meters (m)
Time frame: At 1 month follow-up after Arm 1 or 2 completion
Psychopathology, dependence and craving, as well as anthropometric measures
* Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom. * Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology. * Weight is measured in kilograms (Kg) * Heigh is measured in meters (m)
Time frame: At 3 months follow-up after Arm 1 or 2 completion
Psychopathology, dependence and craving, as well as anthropometric measures
* Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom. * Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology. * Weight is measured in kilograms (Kg) * Heigh is measured in meters (m)
Time frame: At 6 months follow-up after Arm 1 or 2 completion
Addictive behaviors
* South Oaks Gambling Screen. The questionnaire consists of 20 items that lead to a total score, ranging from 0 to 20. As higher is the total score, higher is the probability of pathological gambling. * Yale Food Addiction Scale 2. Each item is answered using a 7-point likert scale, ranging from 0 (never) to 7 (always). If the criterion is met, then it is scored as 1. If the score is 0 it means that the criterion has not been met. As more criteria are met, greater is the severity of food addiction. * Internet Gambling Disorder (IGM) DSM-5 criteria. As more items are answered as yes, higher is the severity of the internet addiction. * Hypersexual Behavior Inventory. Each item is answered using a 5-point likert scale, ranging from 1 (never) to 5 (very often). There are 3 factors and each factor has a total score, so as higher is the score in each factor, higher is the hypersexual behaviour.
Time frame: At baseline, at the beginning of hospitalization
Addictive behaviors
* South Oaks Gambling Screen. The questionnaire consists of 20 items that lead to a total score, ranging from 0 to 20. As higher is the total score, higher is the probability of pathological gambling. * Yale Food Addiction Scale 2. Each item is answered using a 7-point likert scale, ranging from 0 (never) to 7 (always). If the criterion is met, then it is scored as 1. If the score is 0 it means that the criterion has not been met. As more criteria are met, greater is the severity of food addiction. * Internet Gambling Disorder (IGM) DSM-5 criteria. As more items are answered as yes, higher is the severity of the internet addiction. * Hypersexual Behavior Inventory. Each item is answered using a 5-point likert scale, ranging from 1 (never) to 5 (very often). There are 3 factors and each factor has a total score, so as higher is the score in each factor, higher is the hypersexual behaviour.
Time frame: Once the 8-week outpatient treatment is completed
Personality and emotion regulation
* Sensitivity to Punishment and Sensitivity to Reward Questionnaire. The score of each scale ranges from 0 to 24, with a greater score indicating more sensitivity to punishment or to reward. * UPPS-P Impulsive Behaviour Scale. Items are answered using a 4-point likert scale. Each sub-scale has a total score, where high values indicate higher levels of impulsivity. * Difficulties in Emotion Regulation Scale. Each item is answered using a 5-point likert scale, and each sub-scale has a total score. As higher is the score in the sub-scale, there are more difficulties in emotional regulation. * Emotion Regulation Questionnaire. Items are answered using a 7-point likert scale. Each sub-scale has a total score, where a higher value indicates a greater use of that emotion regulation strategy. * Multidimensional Assessment of Interoceptive Awareness. Each item is answered using a 5-point likert scale. There are 8 sub-scales where higher scores indicate higher levels of positive awareness.
Time frame: At baseline, at the beginning of hospitalization
Personality and emotion regulation
* UPPS-P Impulsive Behaviour Scale. Items are answered using a 4-point likert scale. Each sub-scale has a total score, where high values indicate higher levels of impulsivity. * Difficulties in Emotion Regulation Scale. Each item is answered using a 5-point likert scale, and each sub-scale has a total score. As higher is the score in the sub-scale, there are more difficulties in emotional regulation. * Emotion Regulation Questionnaire. Items are answered using a 7-point likert scale. Each sub-scale has a total score, where a higher value indicates a greater use of that emotion regulation strategy.
Time frame: At hospitalization completion, an average of 14 days
Personality and emotion regulation
* UPPS-P Impulsive Behaviour Scale. Items are answered using a 4-point likert scale. Each sub-scale has a total score, where high values indicate higher levels of impulsivity. * Difficulties in Emotion Regulation Scale. Each item is answered using a 5-point likert scale, and each sub-scale has a total score. As higher is the score in the sub-scale, there are more difficulties in emotional regulation. * Emotion Regulation Questionnaire. Items are answered using a 7-point likert scale. Each sub-scale has a total score, where a higher value indicates a greater use of that emotion regulation strategy.
Time frame: Once the 8-week outpatient treatment is completed