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NCT Number: NCT07551830

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Târgu Mureş, Mureș County, 540142, Romania

Location contact

Octavian C. Popa, Assoc.Prof.

CONTACT

[email protected]

+40745092686

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cristiana M. Cojocaru, Lecturer

CONTACT

[email protected]

+4-757867711

Octavian C. Popa, Assoc.Prof.

CONTACT

[email protected]

+40745092686

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: PBAT Addiction

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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