Clinical trial NCT06366100: Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction
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 Therapy(DBT) and Unified Protocol (UP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implementation Science
Keywords: Implementation science
Alcohol addiction
Transdiagnostic interventions
Dialectical Behavior Therapy
Unified Protocol
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Ministerio de Sanidad, Servicios Sociales e Igualdad
First posted: 2024-04-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to two groups in parallel for the duration of the study. The specific design is an reverse counterbalanced (ABBA) intrasubject experimental study where participants will be randomly assigned to first (and then the other) receive DBT-SUD or UP online training in the phase 1 of the study, and randomly assigned to first implement DBT-SUD or UP intervention in the phase two. A balanced randomization (1:1) will be conducted in order to eliminate possible biases and ensure equivalence between groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 (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.

Eligibility criteria: Phase 1:

Inclusion Criteria:

* Be at least 18 years of age
* 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

Exclusion Criteria:

* Not being interested in receiving training in emotional regulation 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 training sessions

Phase 2:

Inclusion criteria:

* 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 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

Primary outcomes:
measure: Acceptability and Intention to Use Survey
timeFrame: Phase 1: Last session of DBT and UP trainings; up to 3 weeks for each training (3 weekly sessions of 6-7 hours each); Phase 2: Last session of DBT or UP implementation (3 months, 12-14 weeks for each intervention)
measure: Measures of Acceptability, Appropriateness and Feasibility of the intervention (AIM, IAM & FIM)
timeFrame: Phase 1: After DBT and UP trainings; last session of training: up to 3 weeks for each training (3 weekly sessions of 6-7 hours each); Phase 2: Last session of DBT or UP implementation (3 months, 12-14 weeks for each intervention)
measure: Normalization MeAsure Development Questionnaire (NoMAD)
timeFrame: Phase 2: Before and after implementation: first and last session of DBT or UP (3 months, 12-14 weeks for each intervention)
Secondary outcomes:
measure: Copenhagen Burnout Inventory (CBI)
timeFrame: Phase 1: Before & after DBT and UP trainings (first and last session of training; up to 3 weeks for each training); Phase 2: Before and after implementation: first and last session of DBT or UP implementation (3 months, 12-14 weeks for each intervention)
measure: Brief Scale of Understanding Substance Abuse (SUSS)
timeFrame: Phase 1: After DBT and UP trainings (first and last session of training; up to 3 weeks for each training); Phase 2: Before and after implementation: first and last session of DBT or UP implementation (3 months, 12-14 weeks for each intervention)
measure: Implementation Climate Scale (ICS)
timeFrame: Phase 1: Before and after DBT and UP trainings (first and last session of training; up to 3 weeks for each training); Phase 2: After implementation: last session of DBT or UP (3 months, 12-14 weeks for each intervention)
measure: Organizational Readiness for Implementing Change (ORIC)
timeFrame: Phase 1: After DBT and UP trainings (first and last session of training; up to 3 weeks for each training); Phase 2: Before and after implementation: first and last session of DBT or UP (3 months, 12-14 weeks for each intervention)
measure: Evidence-Based Practice Attitudes Scale (EBPAS)
timeFrame: Phase 1: Before and after DBT and UP trainings (first and last session of training; up to 3 weeks for each training); Phase 2: After implementation: last session of DBT or UP (3 months, 12-14 weeks for each intervention)
measure: Program sustainability assessment tool (PASAT)
timeFrame: Phase 2: After implementation: last session of DBT or UP (3 months, 12-14 weeks for each intervention)
measure: Barriers to Implementation Inventory (BTI)
timeFrame: Phase 1: Last session of DBT and UP trainings; up to 3 weeks for each training (3 weekly sessions of 6-7 hours each); Phase 2: Last sesion of DBT or UP implementation (3 months, 12-14 weeks for each intervention)
Other outcomes:
Locations:
city: Teruel
country: Spain
facility: University of Zaragoza
state: Aragón
Study officials:
affiliation: Universidad de Zaragoza
name: María Vicenta Navarro Haro, PhD
role: PRINCIPAL_INVESTIGATOR
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