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Enrolling by invitation NCT07561749

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

— Observational Alcohol Abstinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Alcohol Abstinence. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

MCMI-IV Personality Changes and Spiritual Coping as Dual Predictors of Serene Abstinence in Romanian Adults With Alcohol Use Disorder: A Longitudinal Observational Study (SER-ABS-AUD Study)

Overview

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.

Detailed description

The study adopts a biopsychosocial-spiritual framework in which biological (sleep, energy, craving), psychological (mood, anhedonia, resilience), social (relationships, employment, community support) and spiritual (meaning, values, forgiveness, inner peace) dimensions jointly shape long-term recovery trajectories. MCMI-IV provides standardized assessment of personality patterns and clinical syndromes, with particular emphasis on Scale B (Alcohol Dependence), Scale D (Dysthymia), Scale A (Anxiety), and personality scales 2 (Avoidant), 3 (Depressive) and 11 (Masochistic) as theoretically relevant to recovery barriers, guilt and self-sabotage.

Participants with at least 12 months abstinence are assessed at two time-points (baseline T1: retrospective past-year profile; T2: prospective current profile at 12-month follow-up), using MCMI-IV and a 4-dimension supplementary questionnaire (biological, psychological, social, spiritual), plus validated short scales (PHQ-9, FACIT-Sp, SWLS, MOS Social Support). The primary outcome is a composite Serene Abstinence Index integrating MCMI-IV dysthymia reduction, natural reward response, spiritual well-being and quality-of-life improvement; logistic regression models will estimate the predictive value of MCMI-IV scales for serene versus struggle abstinence, controlling for sociodemographic and clinical covariates.

Primary outcome measures

  • Serene Abstinence Index at 12 Months (Binary: Serene vs Struggle Abstinence) [Time frame: 1 year]
Secondary outcome measures (6)
  • Change in MCMI-IV Personality and Clinical Syndrome Scales [Time frame: 1 year]
  • 3. Biological Functioning Composite Score [Time frame: 1 year]
  • Psychological Resilience Composite Score [Time frame: 1 year]
  • Social Reintegration Composite Score [Time frame: 1 year]
  • Spiritual Well-Being Composite (FACIT-Sp-Adapted) [Time frame: 1 year]
  • Self-Reported Relapse Events (Exploratory) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Romania · 1 center
  • Association of Recovering Alcoholics Don Orione — Iași

Identifiers

NCT: NCT07561749 · IRB 733/9.3.2026 · SER-ABS-AUD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗