Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction

Implementation Science Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366100
• Other study ID #: 2023I060
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Universidad de Zaragoza
• Contact: María Vicenta Navarro Haro, PhD
• Phone: +34978618145
• Email: mvnavarro[@]unizar.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Behavior, Addictive
• Implementation Science

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Spain	University of Zaragoza	Teruel	Aragón

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Zaragoza	Ministerio de Sanidad, Servicios Sociales e Igualdad

Country where clinical trial is conducted

Spain, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability and Intention to Use Survey	This 9-item instrument is based on the Theoretical Framework of Acceptability (TFA) and assesses acceptability and unifies approaches into a single theoretical framework. The model is composed of seven constructs: Affective attitude; Burden; Ethics; Consistency of intervention; Opportunity costs; Perceived efficacy and Self-efficacy. This questionnaire was created ad hoc in Spanish language by the authors of the instrument and adds two more items reflecting general acceptability and intention to use the intervention in the future.	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)
Primary	Measures of Acceptability, Appropriateness and Feasibility of the intervention (AIM, IAM & FIM)	This is a 12-item instrument with three scales (acceptability, appropriateness and feasibility) and contains statements about the intervention to be measured. These measures could be used independently or together. They will be used together in this study. The instrument presents solid psychometric properties: Cronbach alphas were between .87 and .89 and by subscales alpha were .85 for acceptability, .91 for appropriateness and .89 for feasibility (minimum=0.70 and maximum=0.90 acceptable Cronbach´s alpha scores). The original scale has been back-translated for their correct adaptation to Spanish language.	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)
Primary	Normalization MeAsure Development Questionnaire (NoMAD)	This 12-item questionnaire measures implementation processes from the perspective of professionals directly involved in the implementation of complex interventions in health care. It has four dimensions: coherence of the intervention with daily routine, cognitive participation, collective action of individuals and groups to apply the innovation in daily practice, and reflective monitoring. This instrument was validated for the implementation of complex interventions in primary care, showing adequate psychometric properties. Most values for Cronbach alphas for all four of sub-scales (pooled across site) by time point reached satisfactory thresholds: a = 0.70. The Spanish version will be used, which was developed by the ImpleMentAll partners (https://www.implementall.eu/9-outcomes-and-resources.html#NoMADtranslations).	Phase 2: Before and after implementation: first and last session of DBT or UP (3 months, 12-14 weeks for each intervention)
Secondary	Copenhagen Burnout Inventory (CBI)	The 18-item questionnaire is in the public domain for the measurement of burnout syndrome, and is structured in three subdimensions: personal, work-related, and work-related with clients. It presents good internal consistency of the three scales: Cronbach's alpha for total instrument was >.70 and of .90 in the personal dimension, .83 in the work-related dimension and .82 in the dimension related to dealing with clients).	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)
Secondary	Brief Scale of Understanding Substance Abuse (SUSS)	This 19-items instrument has statements about the nature and etiology of alcohol and substance abuse disorders and consists of three subscales: disease model, psychosocial model, and eclectic orientation. This scale presents good internal consistency scores for its first two scales: Cronbach's alphas of .86 and .72, respectively, and low score .61 for eclectic orientation subscale (minimum=0.70 and maximum=0.90 acceptable Cronbach´s alpha scores) . The scale has been back-translated for their correct adaptation to Spanish language.	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)
Secondary	Implementation Climate Scale (ICS)	This 18-item measure assesses the degree to which there is a strategic organizational climate that supports the implementation of evidence-based practices. the implementation of evidence-based practices. The implementation climate is defined as the perception of the policies, practices, procedures, and behaviors that are rewarded, supported, and expected to facilitate the effective implementation of EBP. This scale was validated with organizations that implemented substance use disorder treatments and showed good psychometric properties. Cronbach's alpha reliabilities for the subscales and ICS total score ranged from .78-.90, demonstrating strong internal consistency reliability (minimum=0.70 and maximum=0.90 acceptable Cronbach´s alpha scores). To adapt this instrument to Spanish, a back-translation was conducted.	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)
Secondary	Organizational Readiness for Implementing Change (ORIC)	This 12-item scale is divided into two main subscales: Commitment to change (i.e., do the intended members of the organization want change?) and Effectiveness of change (i.e., can the members of the organization change?). Cronbach's alpha values were, respectively, 0.91 and 0.89 for the Change Commitment Scale and the Change Efficacy Scale. Spanish version was developed by ImpleMentAll partners (https://www.implementall.eu/9-outcomes-and-resources.html#ORICtranslations).	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)
Secondary	Evidence-Based Practice Attitudes Scale (EBPAS)	This 15-item scale assesses participants' attitudes toward adopting evidence-based practice in four domains: Likelihood of adopting EBP given the requirements to do so, Intuitive appeal of EBP, Openness to new practices, and Perceived divergence of usual practice from EBP. The tool presents an overall scale alpha range of .77-.79 and a range of .78-0.93 for subscales, excluding perceived divergence with somewhat lower reliability: a range of .59-.66 (minimum=0.70 and maximum=0.90 acceptable Cronbach´s alpha scores). This subscale was excluded for this study.	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)
Secondary	Program sustainability assessment tool (PASAT)	This is a 40-item scale of intervention sustainability as reported by the organization's provider and stakeholders. The subscales are: political support, funding stability, stakeholder partnerships, organizational capacity, program evaluation, program adaptation, stakeholder communication, and strategic planning. The average internal consistency of the 8 subscales was .88 and ranged from .79-.92 (minimum=0.70 and maximum=0.90 acceptable Cronbach´s alpha scores) . The Spanish version, developed by the Washington University, St. Louis (US) is available on its official website at: https://sustaintool.org/psat/assess/	Phase 2: After implementation: last session of DBT or UP (3 months, 12-14 weeks for each intervention)
Secondary	Barriers to Implementation Inventory (BTI)	The 39-item inventory consists of a list of barriers that teams may encounter when implementing DBT. The obstacles are structured by the following domains: team problems, administrative problems, theoretical/philosophical problems, and structural problems. The validation study of the original scale showed adequate psychometric properties, the internal reliability of the scores was good: Cronbach´s alpha .89 (minimum=0.70 and maximum=0.90 acceptable Cronbach´s alpha scores). However, in this some adjustments of the scale were conducted using the barriers reported by the scientific literature when implementing evidence-based treatments for addiction. The scale has been back-translated for their correct adaptation to Spanish.	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)