Improvement of Cocaine Use Disorder Treatment Through Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)
- Conditions
- Cocaine Use Disorder
- Interventions
- Behavioral: CBT4CBT
- Registration Number
- NCT05207228
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- inpatients for cocaine detoxification in our addiction unit who live in Barcelona or surroundings
- abstinent at the time of the study assessment (from the third day of hospitalization)
- 18 years of age or older.
- indication of treatment for reasons other than cocaine detoxification,
- presence of serious psychopathological or neuropsychological alterations that hinder the participation in the study (including severe intoxication)
- opioid abuse or dependence during the last year (this criteria includes maintenance treatment with methadone or another opioid substance)
- a lack of Spanish or Catalan knowledge or difficulties to read or write that hamper the participation in the study,
- Non-acceptance of the study procedures, such as the signing of informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment as usual + CBT4CBT CBT4CBT After completing the inpatient care (at discharge), the patients randomly assigned to the experimental condition will receive the TAU + CBT4CBT a web-based treatment which has been tested on individuals with cocaine use disorder in America by the team of Dr. K.M. Carroll.
- Primary Outcome Measures
Name Time Method Treatment retention At 6 months follow-up after completing Arm 1 or 2 Change from baseline treatment retention versus drop out at 6 months after treatment at follow-up time point.
Relapse At 6 months follow-up after Arm 1 or 2 5. Change from baseline at 6 months after outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine at follow-up timepoint.
- Secondary Outcome Measures
Name Time Method Psychopathology, dependence and craving, as well as anthropometric measures At 6 months follow-up after Arm 1 or 2 completion * 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)Addictive behaviors Once the 8-week outpatient treatment is completed * 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.Personality and emotion regulation Once the 8-week outpatient treatment is completed * 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.
Trial Locations
- Locations (1)
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain