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Not yet recruiting NCT07551830

Process-Based Psychological Processes in Alcohol Use Disorder: A Case-Control Study Using PBAT, PHQ-9, and GAD-7

— Observational Alcohol Use Disorder (AUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder (AUD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This observational study investigates differences in psychological processes and emotional symptoms between individuals with Alcohol Use Disorder (AUD) and a non-clinical control group. PBAT, PHQ-9, and GAD-7 will be used. MANCOVA will test group differences controlling for demographics.

Detailed description

The present study is grounded in the process-based approach to psychopathology, which emphasizes the identification and modification of core psychological processes underlying mental disorders, rather than focusing exclusively on categorical diagnoses.

A central theoretical framework guiding this approach is the Extended Evolutionary Meta-Model (EEMM), which conceptualizes psychological functioning and psychopathology through evolutionary principles:

* Variation - the ability to generate flexible and adaptive behavioral responses * Selection - the capacity to choose behaviors aligned with personal goals and contextual demands * Retention - the maintenance and consolidation of adaptive behaviors over time * Context - sensitivity to environmental and situational factors influencing behavior

According to this model, psychopathology (including Alcohol Use Disorder) is characterized by psychological inflexibility, maladaptive behavioral selection, and poor retention of functional strategies, often in interaction with contextual insensitivity.

These processes operate across multiple domains, including affect, cognition, attention, motivation, self, and overt behavior.

Primary outcome measures

  • Process-Based Assessment Tool [Time frame: After enrollment (single time point).]
Secondary outcome measures (2)
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: After enrollment (single time point).]
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: After enrollment (single time point).]

Eligibility criteria

Inclusion criteria

  • age ≥18, the ability to provide informed consent, no psychiatric diagnosis (for the control group).

Exclusion criteria

  • severe cognitive impairment, psychosis, inability to complete questionnaires.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Romania · 1 center
  • George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures — Târgu Mureş

Publications

  • Popa CO, Schenk A, Cojocaru CM, Gyorgy M, Sava FA, Marian S, Popoviciu H, Szasz S. A Transdiagnostic Approach in Psychodiagnosis: The Romanian Adaptation of the Process-Based Assessment Tool (PBAT). Behav Sci (Basel). 2025 Dec 8;15(12):1697. doi: 10.3390/bs15121697. PMID 41464040
  • Wang Y, Tian J, Yang Q. Experiential Avoidance Process Model: A Review of the Mechanism for the Generation and Maintenance of Avoidance Behavior. Psychiatry Clin Psychopharmacol. 2024 Jun 1;34(2):179-190. doi: 10.5152/pcp.2024.23777. eCollection 2024 Jun. PMID 39165887
  • Karekla M, Georgiou K, Lamprou E. Acceptance and Commitment Therapy for Substance Use Disorders. Psychiatr Clin North Am. 2025 Sep;48(3):537-550. doi: 10.1016/j.psc.2025.02.008. Epub 2025 Apr 7. PMID 40738532
  • de Aguiar ACL, Bloc LG. Transdiagnosis of alcohol use and psychopathologies: A systematic review. Addict Behav Rep. 2024 Apr 4;19:100543. doi: 10.1016/j.abrep.2024.100543. eCollection 2024 Jun. PMID 38628974

Identifiers

NCT: NCT07551830 · PBATADD2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗