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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Serene Abstinence Index at 12 Months (Binary: Serene vs Struggle Abstinence) [Срок оценки: 1 year]

Вторичные конечные точки (6)

• Change in MCMI-IV Personality and Clinical Syndrome Scales [Срок оценки: 1 year]
• 3. Biological Functioning Composite Score [Срок оценки: 1 year]
• Psychological Resilience Composite Score [Срок оценки: 1 year]
• Social Reintegration Composite Score [Срок оценки: 1 year]
• Spiritual Well-Being Composite (FACIT-Sp-Adapted) [Срок оценки: 1 year]
• Self-Reported Relapse Events (Exploratory) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Румыния · 1 центр

• Association of Recovering Alcoholics Don Orione — Iași

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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