Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction
NCT ID: NCT06366100
Last Updated: 2024-04-15
Study Results
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Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2024-02-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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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 (i.e. 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 Maffei´s 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, identification/oppositional 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Dialectical Behavior Therapy for Substance Use Disorders (DBT-SUD)
In the first phase of the study, a three-day workshop (20 hours) online training on DBT-SUD intervention will be provided to professionals. In the second phase, participants will implement DBT-SUD in group that will consist of applying the skills training mode of DBT for 3 months (12-14 sessions, two hours each). Regarding the specific contents, they will be based on the program published by Maffei´s team (DBT certified trainer and therapist in Italy), which has shown good results in improving the severity and frequency of alcohol use and emotional dysregulation with a 3-month program. Four modules of the skills training program will be applied: mindfulness, distress tolerance, skills to deal with addiction and emotional regulation skills. A self-management and rehabilitation module will be also included.
Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD)
In phase 1, DBT online training will consist of the following contents:
Block 1
1.1. Introduction to the key concepts 1.2. DBT-SUD program 1.3. Why DBT for alcohol addiction? 1.4. Proposed content for the group intervention.
Block 2
2.1. DBT skills training modules
In phase 2, DBT-SUD intervention will consist of about the following sessions:
GOALS OF SKILLS TRAINING AND MINDFULNESS:
S1: Goals of skills training; Observing, Describing and Participating
S2: Non-judgmentally, One-mindfulness, Effectively
DISTRESS TOLERANCE:
S3: Crisis Survival skills
S4: Crisis Survival and Radical Acceptance
ADDICTION SKILLS:
S5: Dialectical Abstinence.
S6: Clear Mind
S7: Burning Bridges-Building New Bridges
S8: Community Reinforcement
EMOTIONAL REGULATION:
S9: Identifying emotions and model of emotion
S10: Check the facts. Opposing Action
S11: Problem Solving. Reducing vulnerability
S12: Self-management and rehabilitation
Unified Protocol (UP)
In the first phase of the study, a a three-day workshop (20 hours) online training on UP intervention will be provided to professionals. In the second phase, participants will implement the UP program that will consist of 8 treatment modules that include training in 5 core skills of emotional regulation: mindfulness training, cognitive flexibility, identification/oppositional behavior of emotional behaviors, interoceptive exposure and emotional exposure. Our team has adapted the UP to be implemented in 12 group sessions, one per week, lasting 2 hours, in specialized mental health care services of the national health system. Additional recommendations to adapt UP to alcohol addiction will be included.
Unified Protocol (UP)
In phase 1, the UP training will have following contents:
Block 1
1.1. Introduction to key concepts 1.2. Why UP for alcohol addiction? 1.3. Dimensional assessment and case formulation. 1.4. Main characteristics of UP
Block 2
2.1. Modules of UP
In phase 2, UP intervention will consist of:
MOTIVATION:
S1: Motivation enhancement for treatment
UNDERSTANDING EMOTIONS:
S2: Understanding and model of emotions S3: Tracking emotional responses
MINDFULNESS:
S4: Emotion awareness
COGNITIVE FLEXIBILITY:
S5: Cognitive reappraisal to increase thinking flexibility
EMOTION DRIVEN BEHAVIORS:
S6: Emotional avoidance S7: Emotion-driven behaviors and alternative action
AWARENESS AND TOLERANCE:
S8: Tolerance of physical sensations
EMOTIONAL EXPOSURE:
S9: Interoceptive and situational emotion exposure S10: Exposure practice
RELAPSE PREVENTION:
S11: Relapse prevention S12: Review of progress
Interventions
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Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD)
In phase 1, DBT online training will consist of the following contents:
Block 1
1.1. Introduction to the key concepts 1.2. DBT-SUD program 1.3. Why DBT for alcohol addiction? 1.4. Proposed content for the group intervention.
Block 2
2.1. DBT skills training modules
In phase 2, DBT-SUD intervention will consist of about the following sessions:
GOALS OF SKILLS TRAINING AND MINDFULNESS:
S1: Goals of skills training; Observing, Describing and Participating
S2: Non-judgmentally, One-mindfulness, Effectively
DISTRESS TOLERANCE:
S3: Crisis Survival skills
S4: Crisis Survival and Radical Acceptance
ADDICTION SKILLS:
S5: Dialectical Abstinence.
S6: Clear Mind
S7: Burning Bridges-Building New Bridges
S8: Community Reinforcement
EMOTIONAL REGULATION:
S9: Identifying emotions and model of emotion
S10: Check the facts. Opposing Action
S11: Problem Solving. Reducing vulnerability
S12: Self-management and rehabilitation
Unified Protocol (UP)
In phase 1, the UP training will have following contents:
Block 1
1.1. Introduction to key concepts 1.2. Why UP for alcohol addiction? 1.3. Dimensional assessment and case formulation. 1.4. Main characteristics of UP
Block 2
2.1. Modules of UP
In phase 2, UP intervention will consist of:
MOTIVATION:
S1: Motivation enhancement for treatment
UNDERSTANDING EMOTIONS:
S2: Understanding and model of emotions S3: Tracking emotional responses
MINDFULNESS:
S4: Emotion awareness
COGNITIVE FLEXIBILITY:
S5: Cognitive reappraisal to increase thinking flexibility
EMOTION DRIVEN BEHAVIORS:
S6: Emotional avoidance S7: Emotion-driven behaviors and alternative action
AWARENESS AND TOLERANCE:
S8: Tolerance of physical sensations
EMOTIONAL EXPOSURE:
S9: Interoceptive and situational emotion exposure S10: Exposure practice
RELAPSE PREVENTION:
S11: Relapse prevention S12: Review of progress
Eligibility Criteria
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Inclusion Criteria
* Mental health professional (psychologist, psychiatrist, nurse) currently working in an addiction treatment service
* Agree to receive training in DBT and UP programs
* Understand Spanish
* Accept informed consent
* Be at least 18 years of age
* Psychologists currently working in an addiction treatment service
* Have received training in DBT and UP interventions in phase 1
* Accept the implementation of any of the 2 interventions and the supervision during the implementation
* Understand the Spanish language
* Accept the informed consent
Exclusion Criteria
* Not including in their functions, the psychological treatment of people with alcohol addiction
* Not having an Internet connection to be able to connect to the training sessions
Phase 2:
* Not being interested in implementing and/or receiving supervision in the interventions
* Not including in their functions, the psychological treatment of people with alcohol addiction
* Not having an Internet connection to be able to connect to the supervision sessions
18 Years
ALL
Yes
Sponsors
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Ministerio de Sanidad, Servicios Sociales e Igualdad
OTHER_GOV
Universidad de Zaragoza
OTHER
Responsible Party
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María Vicenta Navarro Haro
Associate Professor
Principal Investigators
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María Vicenta Navarro Haro, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Zaragoza
Locations
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University of Zaragoza
Teruel, Aragon, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2023I060
Identifier Type: -
Identifier Source: org_study_id
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