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

NCT06366100 | Recruiting DMC

• 1 other identifier: 2023I060
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Implementation Science

Keywords

Implementation science; Alcohol addiction; Transdiagnostic interventions; Dialectical Behavior Therapy; Unified Protocol

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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: α ≥ 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 Outcomes (7)

• Copenhagen Burnout Inventory (CBI)

  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)

• Brief Scale of Understanding Substance Abuse (SUSS)

  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)

• Implementation Climate Scale (ICS)

  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)

• Organizational Readiness for Implementing Change (ORIC)

  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)

• Evidence-Based Practice Attitudes Scale (EBPAS)

  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)

Study Arms (2)

Dialectical Behavior Therapy for Substance Use Disorders (DBT-SUD)

EXPERIMENTAL

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.

Behavioral: Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD)

Unified Protocol (UP)

EXPERIMENTAL

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.

Behavioral: Unified Protocol (UP)

Interventions

Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD) BEHAVIORAL

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

Dialectical Behavior Therapy for Substance Use Disorders (DBT-SUD)

Unified Protocol (UP) BEHAVIORAL

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

Unified Protocol (UP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Ministerio de Sanidad, Servicios Sociales e Igualdad: collaborator

Study Sites (1)

University of Zaragoza

Teruel, Aragon, C/ Ciudad Escolar S/N44003, Spain

RECRUITING

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MeSH Terms

Conditions

Alcoholism

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• María Vicenta Navarro Haro, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Vicenta Navarro Haro, PhD

CONTACT

+34978618145; mvnavarro@unizar.es

Alba Abanades Morillo, PhD student

CONTACT

+34978618145; aabanades@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 15, 2024
• Study Start: February 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)