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Not yet recruitingNCT07551830PBAT AddictionUpdated Nov 3, 2026

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

An observational study in Alcohol Use Disorder (AUD), sponsored by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures. Not yet recruiting at 1 site in Romania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures · Observational

Updated Nov 3, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Alcohol Use Disorder (AUD)

Keywords

  • Alcohol Use Disorder (AUD)
  • Process-Based Assessment Tool (PBAT)
  • depression
  • anxiety
03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's planned enrollment of 200 is above the median of 159 across 183 observational studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Primary care clinic, community sample.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • severe cognitive impairment, psychosis, inability to complete questionnaires.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Clinical

    AUD diagnosis

  • Control

    Healthy participants

06

What researchers measure

Primary outcomes

  1. Process-Based Assessment Tool

    The scale involves the depiction of psychological and behavioral processes involved in adaptation and maladaptation, according to the Extended Evolutionary Meta-Model. The scale includes 18 items, each involving a stand-alone, individual score, indicating the degree to which the responder engages in the specific process. The scale comprises both positive and negative behavioral strategies.

    Time frame: After enrollment (single time point).

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    The scale involves the assessment of depressive symptoms, with a score range between 0 and 27. Scores between 5 and 9 mean mild depression, 10 to 14 moderate depression, 15 to 19 moderate to severe depression and above 20 severe depression (Kroenke et al., 2001).

    Time frame: After enrollment (single time point).

  2. Generalized Anxiety Disorder-7 (GAD-7)

    The scale involves the assessment of anxiety symptoms, with a score range from 0 to 21. Scores between 5 and 9 indicate mild anxiety, scores between 10 and 14 moderate anxiety, while those above 15 show severe anxiety.

    Time frame: After enrollment (single time point).

07

Study locations

1 site
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 38628974 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — The IPD will not be shared for compliance with the GDPR regulations, given the delicate nature of psychological data.

09

Updates

1 registry update since Sep 25, 2026
Start date
Oct 2026→Dec 2026
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Start date Oct 2026→Dec 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07551830
Lead sponsor
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Responsible party
Octavian Cosmin Popa (Associate Professor Dr., George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures) — Principal investigator
First posted
Apr 27, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Octavian C. Popa, Assoc.Prof.
Contact
cosmin.popa@umfst.ro
+40745092686
Cristiana M. Cojocaru, Lecturer
Contact
cristiana-manuela.cojocaru@umfst.ro
+4-757867711

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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