Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366100
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-02
Brief Title:
Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation DBT and UP for Alcohol Addiction
Sponsor:
Universidad de Zaragoza
Organization:
Universidad de Zaragoza
Study Overview
Official Title:
Dissemination Acceptability and Adaptation Study of Two Transdiagnostic Psychological Interventions Based on Emotional Regulation ER for the Treatment of Alcohol Addiction Dialectical Behavioral TherapyDBT and Unified Protocol UP
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the dissemination and implementation process of two transdiagnostic psychological interventions Dialectical Behavioral Therapy for Substance Use Disorders-DBT-SUD and Unified Protocol-UP to treat alcohol addiction by mental health practitioners in the Spanish National Health System The main questions this study aims to answer are
Are there differences before and after receiving DBT-SUD and UP training in the attitudes toward evidence-based psychological treatments EBPTs level of burnout and organizational climate and readiness to implement the interventions in mental health practitioners working with alcohol addiction
What is the degree of acceptability and intention to use the interventions in clinical practice with people with alcohol addiction of the practitioners after each training DBT-SUD and UP
In what degree the implementation outcomes adoption reach appropriateness feasibility fidelity sustainability will be achieved by the practitioners implementing DBT-SUD and UP in clinical practice
What are the main barriers and facilitators that practitioners will encounter during the process of implementing DBT-SUD and UP in clinical practice
What variables will predict a successful implementation considering previous characteristics of the professionals and the organizational outcomes
The study comprises two phases In the first phase mental health professionals working on addiction services of the Spanish National Health System will be randomly assigned to receive training in one intervention and then the other DBT-SUD and UP and will be evaluated before and after each training In the second phase participants will be randomly assigned to implement one intervention first and then the other in their workplaces with people with alcohol addiction and will be also assessed before and after the implementation Qualitative and quantitate outcome measures will be analyzed using a Mixed- Methods-Design
Are there differences before and after receiving DBT-SUD and UP training in the attitudes toward evidence-based psychological treatments EBPTs level of burnout and organizational climate and readiness to implement the interventions in mental health practitioners working with alcohol addiction
What is the degree of acceptability and intention to use the interventions in clinical practice with people with alcohol addiction of the practitioners after each training DBT-SUD and UP
In what degree the implementation outcomes adoption reach appropriateness feasibility fidelity sustainability will be achieved by the practitioners implementing DBT-SUD and UP in clinical practice
What are the main barriers and facilitators that practitioners will encounter during the process of implementing DBT-SUD and UP in clinical practice
What variables will predict a successful implementation considering previous characteristics of the professionals and the organizational outcomes
The study comprises two phases In the first phase mental health professionals working on addiction services of the Spanish National Health System will be randomly assigned to receive training in one intervention and then the other DBT-SUD and UP and will be evaluated before and after each training In the second phase participants will be randomly assigned to implement one intervention first and then the other in their workplaces with people with alcohol addiction and will be also assessed before and after the implementation Qualitative and quantitate outcome measures will be analyzed using a Mixed- Methods-Design
Detailed Description:
Alcohol addiction is among the most frequent mental health problems in Spain affecting more than 4 of the general population and it accounts for around 35 of admissions to outpatient services of Spanish National Health System NHS Alcohol addiction has significant morbidity and mortality and several comorbidities that limit the effectiveness of psychological treatments The scientific literature suggests that emotional dysregulation is one of the most important determinants of craving and relapse therefore may represent a promising target for improving psychological treatments for alcohol addiction Recently different transdiagnostic psychological treatments have been focused on the etiological and maintenance mechanisms underlying different disorders providing a comprehensive model to treat emotion dysregulation From this perspective alcohol use has been considered a maladaptive behavior to regulate aversive emotional states DBT and UP are two examples of transdiagnostic treatments with good efficacy and effectiveness results to treat emotion dysregulation and have shown preliminary effectiveness to treat alcohol addiction Research studies on psychological treatments have traditionally focused on the efficacy of evidence-based interventions However there is a major problem in translating these treatments into the clinical practice Because research on dissemination and implementation is a relatively new area of study in the addictions field little is known about how to optimize the implementation of evidence-based psychological treatment One of the main barriers encountered in the implementation of psychological interventions for alcohol addiction is the inadequate training of professionals With regard to facilitators providers familiarity with the interventions perception of their effectiveness and attitudes toward them have been found to be associated with the likelihood of success in treatment implementation
In this study two sequential phases are proposed The first phase aims to evaluate the effect of the dissemination of two treatments DBT-SUD and UP on the attitudes readiness to change acceptability and intention to use these interventions in mental health professionals as well as to explore information on the adaptation of both interventions to real contexts of public addiction settings The participants in phase 1 will be at least 160 mental health professionals psychiatrist psychologist and nurse who work in the Spanish NHS drug addiction services of Aragón Valencia and Catalonia regions and are treating people with alcohol addiction In this phase 1 after they provide informed consent participants will be randomized assigned to receive online training in one intervention and then the other DBT-SUD and UP the content of these trainings can be consulted in the intervention section and will complete a series of questionnaires before and after each training In addition to the battery of questionnaires they are described in the outcome measures section to collect qualitative information participants will be given the possibility to participate in small focus groups The questions included in the focus group interviews will explore the acceptability and intention to use both interventions DBT and UP as well as possible adaptations that would be needed to implement them in clinical practice
The second phase aims to evaluate variables regarding implementation ie barriers adoption adequation fidelity of the interventions The main purpose of this phase is to promote an adequate implementation of transdiagnostic interventions in the reality of addiction services of the NHS In this phase 2 of the study it was expected to recruit at least 20 of the professionals trained in phase 1 Participants will be randomly assigned to implement one of the interventions first and then the other DBT-SUD or UP Quantitative measures will be administered before during and after the implementation process Professionals may voluntarily participate in small discussion groups The following variables are proposed to be evaluated during this phase 1 acceptability 2 adoption and reach 3 appropriateness 4 feasibility 5 fidelity 6 barriers and facilitators of implementation The implementation of DBT-SUD and UP interventions will be done in a group format and will last around 3 months in a weekly basis between 12-14 sessions two hours per session The interventions will be adapted according to the context in which they are applied following the feedback collected by the professionals The DBT-SUD program will consist of applying the DBT skills training The specific contents will be based on Maffeis team adaptations of DBT for alcohol addiction which include emotion regulation skills distress tolerance mindfulness present moment awareness and addiction skills and has shown good results in improving the severity and frequency of alcohol consumption and emotional dysregulation with a 3-month program The UP will consist of 8 treatment modules that include training in 5 core emotional regulation skills mindfulness training cognitive flexibility identificationoppositional behavior of emotional behaviors interoceptive exposure and emotional exposure The content of the intervention will be based on previous recommendations for the adequate implementation of the UP in substance use disorders To guarantee implementation of the interventions supervisions by the experts will be carried out session by session with the aim of evaluating treatment fidelity and help practitioners overcome barriers during the implementation process
In this study two sequential phases are proposed The first phase aims to evaluate the effect of the dissemination of two treatments DBT-SUD and UP on the attitudes readiness to change acceptability and intention to use these interventions in mental health professionals as well as to explore information on the adaptation of both interventions to real contexts of public addiction settings The participants in phase 1 will be at least 160 mental health professionals psychiatrist psychologist and nurse who work in the Spanish NHS drug addiction services of Aragón Valencia and Catalonia regions and are treating people with alcohol addiction In this phase 1 after they provide informed consent participants will be randomized assigned to receive online training in one intervention and then the other DBT-SUD and UP the content of these trainings can be consulted in the intervention section and will complete a series of questionnaires before and after each training In addition to the battery of questionnaires they are described in the outcome measures section to collect qualitative information participants will be given the possibility to participate in small focus groups The questions included in the focus group interviews will explore the acceptability and intention to use both interventions DBT and UP as well as possible adaptations that would be needed to implement them in clinical practice
The second phase aims to evaluate variables regarding implementation ie barriers adoption adequation fidelity of the interventions The main purpose of this phase is to promote an adequate implementation of transdiagnostic interventions in the reality of addiction services of the NHS In this phase 2 of the study it was expected to recruit at least 20 of the professionals trained in phase 1 Participants will be randomly assigned to implement one of the interventions first and then the other DBT-SUD or UP Quantitative measures will be administered before during and after the implementation process Professionals may voluntarily participate in small discussion groups The following variables are proposed to be evaluated during this phase 1 acceptability 2 adoption and reach 3 appropriateness 4 feasibility 5 fidelity 6 barriers and facilitators of implementation The implementation of DBT-SUD and UP interventions will be done in a group format and will last around 3 months in a weekly basis between 12-14 sessions two hours per session The interventions will be adapted according to the context in which they are applied following the feedback collected by the professionals The DBT-SUD program will consist of applying the DBT skills training The specific contents will be based on Maffeis team adaptations of DBT for alcohol addiction which include emotion regulation skills distress tolerance mindfulness present moment awareness and addiction skills and has shown good results in improving the severity and frequency of alcohol consumption and emotional dysregulation with a 3-month program The UP will consist of 8 treatment modules that include training in 5 core emotional regulation skills mindfulness training cognitive flexibility identificationoppositional behavior of emotional behaviors interoceptive exposure and emotional exposure The content of the intervention will be based on previous recommendations for the adequate implementation of the UP in substance use disorders To guarantee implementation of the interventions supervisions by the experts will be carried out session by session with the aim of evaluating treatment fidelity and help practitioners overcome barriers during the implementation process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None