Interventional Recruiting
NCT06366100 on ClinicalTrials.gov
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)
- Sponsor: Universidad de Zaragoza
- Collaborators: Ministerio de Sanidad, Servicios Sociales e Igualdad
- Enrollment: 160 (Estimated)
- Study start: 2024-02-01 (Actual)
- Primary completion: 2025-06-30 (Estimated)
- Study completion: 2025-12-31 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: 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.
- Masking: None
- PrimaryPurpose: 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.
Conditions
- Implementation Science
Intervention / Treatment
- Behavioral: Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD)
- Behavioral: Unified Protocol (UP)
Primary Outcome Measures
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Acceptability and Intention to Use Survey
(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))
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. -
Measures of Acceptability, Appropriateness and Feasibility of the intervention (AIM, IAM & FIM)
(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))
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. -
Normalization MeAsure Development Questionnaire (NoMAD)
(Phase 2: Before and after implementation: first and last session of DBT or UP (3 months, 12-14 weeks for each intervention))
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).
Countries
Spain
Locations and Investigators
-
University of Zaragoza, Teruel, Spain (Recruiting)
- MarÃa Vicenta Navarro Haro, PhD
Study Officials
- MarÃa Vicenta Navarro Haro, PhD (Principal Investigator) — Universidad de Zaragoza