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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT4CBT | Behavioral | Cognitive behavioral treatment through the web CBT4CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse | 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. | 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. | 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. | 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. | 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. | 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. | Through hospitalization completion, an average of 14 days |
| Treatment retention |
| Measure | Description | Time Frame |
|---|---|---|
| Psychopathology, dependence and craving, as well as anthropometric measures |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuria Mallorquí, PhD | Contact | 935537665 | nmallorqui@santpau.cat | |
| Anna Alonso, PhD | Contact | 935537665 | aalonsos@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Núria Mallorquí, PhD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40983318 | Derived | Palazon-Llecha A, Trujols J, Madre M, Duran-Sindreu S, Batlle F, Mallorqui-Bague N. The Predictive Value of Emotion Regulation in Cocaine Use Disorder Severity: Psychotherapeutic Implications During Hospitalization for Detoxification. Clin Psychol Psychother. 2025 Sep-Oct;32(5):e70155. doi: 10.1002/cpp.70155. | |
| 36937712 | Derived |
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Change from baseline at 8 weeks of outpatient treatment during the 8-week period of Arm 1 or 2. |
| Through the 8-week period of arm 1 or 2 |
| Treatment retention | Change from baseline at 1 month after outpatient treatment. | At 1 month follow-up after completing Arm 1 or 2 |
| Treatment retention | Change from baseline at 3 months after outpatient treatment. | 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. | At 6 months follow-up after completing Arm 1 or 2 |
| At baseline, at the beginning of hospitalization |
| Psychopathology, dependence and craving, as well as anthropometric measures |
| At hospitalization completion, an average of 14 days |
| Psychopathology, dependence and craving, as well as anthropometric measures |
| Once the 8-week outpatient treatment is completed |
| Psychopathology, dependence and craving, as well as anthropometric measures |
| At 1 month follow-up after Arm 1 or 2 completion |
| Psychopathology, dependence and craving, as well as anthropometric measures |
| At 3 months follow-up after Arm 1 or 2 completion |
| Psychopathology, dependence and craving, as well as anthropometric measures |
| At 6 months follow-up after Arm 1 or 2 completion |
| Addictive behaviors |
| At baseline, at the beginning of hospitalization |
| Addictive behaviors |
| Once the 8-week outpatient treatment is completed |
| Personality and emotion regulation |
| At baseline, at the beginning of hospitalization |
| Personality and emotion regulation |
| At hospitalization completion, an average of 14 days |
| Personality and emotion regulation |
| Once the 8-week outpatient treatment is completed |
| Mallorqui-Bague N, Palazon-Llecha A, Madre M, Batlle F, Duran-Sindreu S, Trujols J. CBT4CBT web-based add-on treatment for cocaine use disorder: Study protocol for a randomized controlled trial. Front Psychiatry. 2023 Mar 2;14:1051528. doi: 10.3389/fpsyt.2023.1051528. eCollection 2023. |