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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process-Based Psychological Processes in Alcohol Use Disorder: A Case-Control Study Using PBAT, PHQ-9, and GAD-7
- ClinicalTrials.gov ID
- NCT07551830
- Acronym / sponsor ID
- PBAT Addiction / PBATADD2026
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol Use Disorder (AUD), Process-Based Assessment Tool (PBAT), depression, anxiety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu MuresUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical | – | –AUD diagnosis |
| Control | – | –Healthy participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, community sample.
Key inclusion criteria (1 listed)
- age ≥18, the ability to provide informed consent, no psychiatric diagnosis (for the control group).
Key exclusion criteria (1 listed)
- severe cognitive impairment, psychosis, inability to complete questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Process-Based Assessment Tool
Time frame: After enrollment (single time point).
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.
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 41464040Popa 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.
- Background: PubMed 39165887Wang 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.
- Background: PubMed 40738532Karekla 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.
- Background: PubMed 38628974de 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.
- Individual participant dataSharing planned: No. The IPD will not be shared for compliance with the GDPR regulations, given the delicate nature of psychological data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Sep 2026. 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 Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Octavian C. Popa, Assoc.Prof. (+40745092686, cosmin.popa@umfst.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Process-Based Assessment Tool (time frame: After enrollment (single time point).). 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 NCT07551830, which also lists 4 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 11 Sep 2026.