Alcohol Use Disorder (AUD)PBAT AddictionNCT07551830
Process-Based Psychological Processes in Alcohol Use Disorder: A Case-Control Study Using PBAT, PHQ-9, and GAD-7
An observational study of Alcohol Use Disorder (AUD), run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 1 site in Romania.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- Oct 2026to Jun 2028
- Phase
- Observational
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
Study population: Primary care clinic, community sample.
Who may be able to join
- age ≥18, the ability to provide informed consent, no psychiatric diagnosis (for the control group).
Who cannot join
- severe cognitive impairment, psychosis, inability to complete questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
Târgu Mureş, Mureș County, 540142
Octavian C. Popa, Assoc.Prof., +40745092686, cristianacojocaru28@gmail.com
About this study
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.
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol Use Disorder (AUD), Process-Based Assessment Tool (PBAT), depression, anxiety
- Medical subject headings
- Alcoholism, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical | AUD diagnosis | |
| Control | Healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After enrollment (single time point).
Secondary outcomes (2)
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).
Measured: After enrollment (single time point).
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.
Measured: After enrollment (single time point).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Octavian Cosmin Popa, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551830
- Sponsor's protocol ID
- PBATADD2026
- Acronym
- PBAT Addiction
- Status last verified
- Sep 2026
- First submitted
- 16 Apr 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared for compliance with the GDPR regulations, given the delicate nature of psychological data.
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 41464040Wang 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 39165887Karekla 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 40738532de 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