NCT07551830

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 16, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Alcohol Use Disorder (AUD)Process-Based Assessment Tool (PBAT)depressionanxiety

Outcome Measures

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.

    After enrollment (single time point).

Secondary Outcomes (2)

  • Patient Health Questionnaire-9 (PHQ-9)

    After enrollment (single time point).

  • Generalized Anxiety Disorder-7 (GAD-7)

    After enrollment (single time point).

Study Arms (2)

Clinical

AUD diagnosis

Control

Healthy participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic, community sample.

You may qualify if:

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

You may not qualify if:

  • severe cognitive impairment, psychosis, inability to complete questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Târgu Mureş, Mureș County, 540142, Romania

Location

Related Publications (4)

  • 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.

    PMID: 41464040BACKGROUND
  • 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.

    PMID: 39165887BACKGROUND
  • 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.

    PMID: 40738532BACKGROUND
  • 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.

    PMID: 38628974BACKGROUND

MeSH Terms

Conditions

AlcoholismDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Octavian C. Popa, Assoc.Prof.

CONTACT

Cristiana M. Cojocaru, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr.

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 27, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations