Randomized Clinical Trial (RCT) for the Improvement of Cocaine Use Disorder Treatment Through the Implementation of a Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Treatment retention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Treatment retention
Time Frame: 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
Time Frame: 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 Outcomes
- Psychopathology, dependence and craving, as well as anthropometric measures(At 6 months follow-up after Arm 1 or 2 completion)
- Addictive behaviors(Once the 8-week outpatient treatment is completed)
- Personality and emotion regulation(Once the 8-week outpatient treatment is completed)