SER-ABS-AUD: Bio-Psycho-Socio-Spiritual Predictors of AUD Recovery

NCT07561749 | Enrolling By Invitation DMC

• 2 other identifiers: IRB 733/9.3.2026SER-ABS-AUD
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol use disorder (AUD) remains a major public health burden in Romania, with very high alcohol-attributable mortality and years of life lost. Conventional treatment focuses on achieving abstinence, but the distinction between "struggle abstinence" (persistent cravings, anhedonia, white-knuckle willpower) and "serene abstinence" (anhedonia resolution, restored reward, meaning and quality of life) is poorly characterized in the Romanian context. This longitudinal observational study uses the Millon Clinical Multiaxial Inventory-IV (MCMI-IV) together with a brief neuropsychosocial-spiritual battery to identify which personality patterns and clinical syndromes predict serene versus struggle abstinence in adults with DSM-5 alcohol use disorder who maintain at least 12 months of sobriety in Romanian community recovery settings.

Conditions

Alcohol Abstinence

Keywords

Alcohol use disorder; Serene abstinence; Struggle abstinence; MCMI-IV; Support groups; Romania

Outcome Measures

Primary Outcomes (1)

• Serene Abstinence Index at 12 Months (Binary: Serene vs Struggle Abstinence)

  Composite index classifying participants as achieving "serene abstinence" if all of the following criteria are met: (a) MCMI-IV Dysthymia (D) scale reduction ≥15 base-rate points from T1 to T2 (e.g. ≥75 BR to ≤60 BR); (b) Natural Reward Response score ≥4 on a 1-5 Likert item; (c) Spiritual Well-Being composite score ≥40-50 on FACIT-Sp-adapted items; (d) ≥30% improvement in WHOQOL-BREF or comparable quality-of-life scale. Classification as "serene" is further validated by self-report ("feeling happy and fulfilled most days" vs "just managing to stay sober").

  1 year

Secondary Outcomes (6)

• Change in MCMI-IV Personality and Clinical Syndrome Scales

  1 year

• 3. Biological Functioning Composite Score

  1 year

• Psychological Resilience Composite Score

  1 year

• Social Reintegration Composite Score

  1 year

• Spiritual Well-Being Composite (FACIT-Sp-Adapted)

  1 year

Study Arms (1)

Sustained Abstinence Cohort

All enrolled participants with AUD in ≥12-month abstinence, assessed at T1 (retrospective) and followed prospectively to T2 (12-month follow-up). No experimental intervention is delivered; participants receive usual care in ACAR/Don Orione programs (peer support, psychoeducation, optional psychotherapy), which is documented but not manipulated by investigators

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-70 years with a documented history of DSM-5 alcohol use disorder who have maintained at least 12 months of continuous alcohol abstinence and are currently engaged in recovery support programs at ACAR (Asociația Cluburilor Alcoolicilor în Recuperare), Don Orione Recovery Center, or followed at Institute of Psychiatry "Socola" in Iași, Romania. Participants represent a naturalistic cohort of individuals in sustained remission receiving routine community-based recovery support, assessed longitudinally for biopsychosocial-spiritual factors predicting serene versus struggle abstinence.

You may qualify if:

• Diagnosis of Alcohol Use Disorder according to DSM-5 or ICD-10 criteria documented in clinical records.
• Minimum 12 consecutive months of alcohol abstinence prior to baseline assessment (self-report corroborated by group leaders/clinical notes where available).
• Current or recent participation (last 12 months) in at least one recovery support program (ACAR support groups and/or Don Orione recovery services).
• Ability to understand study procedures and provide written informed consent in Romanian.

You may not qualify if:

• Acute psychiatric conditions requiring emergency intervention (e.g. psychotic episode, severe mania) at screening.
• Active suicidal risk (positive PHQ-9 item on suicidal ideation with associated clinical concern) requiring urgent care.
• Uncontrolled comorbid substance use disorder (e.g. ongoing illicit drug dependence) that would confound assessment of alcohol-related recovery.
• Legal incapacity or inability to provide informed consent.
• Severe cognitive impairment (e.g. MMSE below functional threshold) precluding valid questionnaire completion (to be screened where indicated).

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

Acar Don Orione

Iași, 707405, Romania

Location

MeSH Terms

Conditions

Alcohol Abstinence; Alcoholism

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andreea S Szalontay, Prof. Dr.

  University of Medicine and Pharmacy "Grigore T. Popa" Iași Romania

  STUDY CHAIR

• Alexandra M Gaina, MD

  Grigore T Popa University of Medicine and Pharmacy PhD Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: May 1, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 20, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)