Clinical trial NCT05207228: Improvement of Cocaine Use Disorder Treatment Through Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)
Official title: Randomized Clinical Trial (RCT) for the Improvement of Cocaine Use Disorder Treatment Through the Implementation of a Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cocaine Use Disorder
Keywords: Cocaine Use Disorder
Treatment
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relapse
timeFrame: Through hospitalization completion, an average of 14 days
measure: Relapse
timeFrame: Through the 8-week period of arm 1 or 2.
measure: Relapse
timeFrame: At 1 month follow-up after Arm 1 or 2
measure: Relapse
timeFrame: At 3 months follow-up after Arm 1 or 2
measure: Relapse
timeFrame: At 6 months follow-up after Arm 1 or 2
measure: Treatment retention
timeFrame: Through hospitalization completion, an average of 14 days
measure: Treatment retention
timeFrame: Through the 8-week period of arm 1 or 2
measure: Treatment retention
timeFrame: At 1 month follow-up after completing Arm 1 or 2
measure: Treatment retention
timeFrame: At 3 months follow-up after completing Arm 1 or 2
measure: Treatment retention
timeFrame: At 6 months follow-up after completing Arm 1 or 2
Secondary outcomes:
measure: Psychopathology, dependence and craving, as well as anthropometric measures
timeFrame: At baseline, at the beginning of hospitalization
measure: Psychopathology, dependence and craving, as well as anthropometric measures
timeFrame: At hospitalization completion, an average of 14 days
measure: Psychopathology, dependence and craving, as well as anthropometric measures
timeFrame: Once the 8-week outpatient treatment is completed
measure: Psychopathology, dependence and craving, as well as anthropometric measures
timeFrame: At 1 month follow-up after Arm 1 or 2 completion
measure: Psychopathology, dependence and craving, as well as anthropometric measures
timeFrame: At 3 months follow-up after Arm 1 or 2 completion
measure: Psychopathology, dependence and craving, as well as anthropometric measures
timeFrame: At 6 months follow-up after Arm 1 or 2 completion
measure: Addictive behaviors
timeFrame: At baseline, at the beginning of hospitalization
measure: Addictive behaviors
timeFrame: Once the 8-week outpatient treatment is completed
measure: Personality and emotion regulation
timeFrame: At baseline, at the beginning of hospitalization
measure: Personality and emotion regulation
timeFrame: At hospitalization completion, an average of 14 days
measure: Personality and emotion regulation
timeFrame: Once the 8-week outpatient treatment is completed
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Núria Mallorquí, PhD
role: PRINCIPAL_INVESTIGATOR
References: