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

April 22, 2026 updated by: Octavian Cosmin Popa, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Romania
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540142
        • George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic, community sample.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Healthy participants
Clinical
AUD diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After enrollment (single time point).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: After enrollment (single time point).
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).
After enrollment (single time point).
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: After enrollment (single time point).
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.
After enrollment (single time point).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBATADD2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will not be shared for compliance with the GDPR regulations, given the delicate nature of psychological data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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