Improvement of Cocaine Use Disorder Treatment Through Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Enrolling

Conditions: Cocaine Use Disorder

Treatments: Behavioral: CBT4CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05207228

IIBSP-CTB-2020-116

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Treatment as usual

No Intervention group

Description:

After completing the inpatient care (at discharge of inpatient care), patients randomized to TAU will receive day-care / outpatient treatment.

Treatment as usual + CBT4CBT

Experimental group

Description:

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.

Treatment:

Behavioral: CBT4CBT