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Implementation ScienceNCT06366100

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

A study testing Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD) and Unified Protocol (UP) in people with Implementation Science, run by Universidad de Zaragoza at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Implementation Science
What is being tested?
Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD) and Unified Protocol (UP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSpain
Study dates
1 Feb 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Be at least 18 years of age
Show all 11Show fewer
  • 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

Who cannot join

  • 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:
  • 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

Trial locations and contacts

1 site in 1 country.

María Vicenta Navarro Haro, PhD contact

+34978618145 ext. 861145

mvnavarro@unizar.es

Alba Abanades Morillo, PhD student contact

+34978618145 ext. 861145

aabanades@unizar.es

Spain1 site, 1 recruiting

  • University of Zaragoza

    Teruel, Aragon, C/ Ciudad Escolar S/N44003

    María Vicenta Navarro Haro, PhD, mvnavarro@unizar.es

    Recruiting

Other trials in Spain

About this study

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)

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?

Read more

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.

Read the 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.

Being tested
Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD), Unified Protocol (UP)
Keywords
Implementation science, Alcohol addiction, Transdiagnostic interventions, Dialectical Behavior Therapy, Unified Protocol
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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)Behavioural

    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

Study groups in NCT06366100
Study groupRoleWhat they receive
Dialectical Behavior Therapy for Substance Use Disorders (DBT-SUD)ExperimentalIn 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.
Receives: Behavioral: Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD)
Unified Protocol (UP)ExperimentalIn 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.
Receives: Behavioral: Unified Protocol (UP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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).

    Measured: 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)

  1. 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).

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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).

    Measured: 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)

  5. 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 α range of .78-0.93 for subscales, excluding perceived divergence with somewhat lower reliability: α range of .59-.66 (minimum=0.70 and maximum=0.90 acceptable Cronbach´s alpha scores). This subscale was excluded for this study.

    Measured: 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)

  6. 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/

    Measured: Phase 2: After implementation: last session of DBT or UP (3 months, 12-14 weeks for each intervention)

  7. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start1 Feb 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06366100
Sponsor's protocol ID
2023I060
Status last verified
Apr 2024
First submitted
2 Apr 2024
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carlucci L, Saggino A, Balsamo M. On the efficacy of the unified protocol for transdiagnostic treatment of emotional disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Jul;87:101999. doi: 10.1016/j.cpr.2021.101999. Epub 2021 Mar 9.

    PubMed 34098412

  • Luke DA, Calhoun A, Robichaux CB, Elliott MB, Moreland-Russell S. The Program Sustainability Assessment Tool: a new instrument for public health programs. Prev Chronic Dis. 2014 Jan 23;11:130184. doi: 10.5888/pcd11.130184.

    PubMed 24456645

  • Molinero Ruiz E, Basart Gomez-Quintero H, Moncada Lluis S. Validation of the Copenhagen Burnout Inventory to assess professional burnout in Spain. Rev Esp Salud Publica. 2013 Mar-Apr;87(2):165-79. doi: 10.4321/S1135-57272013000200006. English, Spanish.

    PubMed 23775105

  • Ehrhart MG, Torres EM, Hwang J, Sklar M, Aarons GA. Validation of the Implementation Climate Scale (ICS) in substance use disorder treatment organizations. Subst Abuse Treat Prev Policy. 2019 Aug 23;14(1):35. doi: 10.1186/s13011-019-0222-5.

    PubMed 31443666

  • Ehrhart MG, Aarons GA, Farahnak LR. Assessing the organizational context for EBP implementation: the development and validity testing of the Implementation Climate Scale (ICS). Implement Sci. 2014 Oct 23;9:157. doi: 10.1186/s13012-014-0157-1.

    PubMed 25338781

  • Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7.

    PubMed 24410955

  • Aarons GA. Mental health provider attitudes toward adoption of evidence-based practice: the Evidence-Based Practice Attitude Scale (EBPAS). Ment Health Serv Res. 2004 Jun;6(2):61-74. doi: 10.1023/b:mhsr.0000024351.12294.65.

    PubMed 15224451

  • Obert JL, Brown AH, Zweben J, Christian D, Delmhorst J, Minsky S, Morrisey P, Vandersloot D, Weiner A. When treatment meets research: clinical perspectives from the CSAT Methamphetamine Treatment Project. J Subst Abuse Treat. 2005 Apr;28(3):231-7. doi: 10.1016/j.jsat.2004.12.008.

    PubMed 15857723

  • Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.

    PubMed 22179294

  • Ciraulo DA, Barlow DH, Gulliver SB, Farchione T, Morissette SB, Kamholz BW, Eisenmenger K, Brown B, Devine E, Brown TA, Knapp CM. The effects of venlafaxine and cognitive behavioral therapy alone and combined in the treatment of co-morbid alcohol use-anxiety disorders. Behav Res Ther. 2013 Nov;51(11):729-35. doi: 10.1016/j.brat.2013.08.003. Epub 2013 Aug 30.

    PubMed 24055681

  • Peris-Baquero O, Osma J, Gil-LaCruz M, Martinez-Garcia L. Acceptability of and intention to use the Unified Protocol delivered in group format in the Spanish Public Health System. J Eval Clin Pract. 2021 Dec;27(6):1299-1309. doi: 10.1111/jep.13546. Epub 2021 Feb 9.

    PubMed 33565231

  • Maffei C, Cavicchioli M, Movalli M, Cavallaro R, Fossati A. Dialectical Behavior Therapy Skills Training in Alcohol Dependence Treatment: Findings Based on an Open Trial. Subst Use Misuse. 2018 Dec 6;53(14):2368-2385. doi: 10.1080/10826084.2018.1480035. Epub 2018 Jun 29.

    PubMed 29958050

  • Cavicchioli M, Movalli M, Vassena G, Ramella P, Prudenziati F, Maffei C. The therapeutic role of emotion regulation and coping strategies during a stand-alone DBT Skills training program for alcohol use disorder and concurrent substance use disorders. Addict Behav. 2019 Nov;98:106035. doi: 10.1016/j.addbeh.2019.106035. Epub 2019 Jun 25.

    PubMed 31302312

  • Spanish Observatory on Drugs and Addictions. Report 2023. Alcohol, tobacco and illegal drugs in Spain. Madrid: Ministry of Health. Government Delegation for the National Plan on Drugs; 2023. 270 p.

  • Connor JP, Haber PS, Hall WD. Alcohol use disorders. Lancet. 2016 Mar 5;387(10022):988-998. doi: 10.1016/S0140-6736(15)00122-1. Epub 2015 Sep 3.

    PubMed 26343838

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD) and Unified Protocol (UP) in people with Implementation Science, run by Universidad de Zaragoza at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact María Vicenta Navarro Haro, PhD (+34978618145 ext. 861145, mvnavarro@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability and Intention to Use Survey (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06366100, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.

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