- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07561749
SER-ABS-AUD: Bio-Psycho-Socio-Spiritual Predictors of AUD Recovery (SER-ABS-AUD)
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)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Iaşi
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Iași, Iaşi, Rumunsko, 707405
- Association of Recovering Alcoholics Don Orione
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Serene Abstinence Index at 12 Months (Binary: Serene vs Struggle Abstinence)
Časové okno: 1 year
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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").
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1 year
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in MCMI-IV Personality and Clinical Syndrome Scales
Časové okno: 1 year
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Within-subject change in MCMI-IV scales B (Alcohol Dependence), D (Dysthymia), A (Anxiety), 2 (Avoidant), 3 (Depressive), 11 (Masochistic); effect sizes (Cohen's d) and proportion of participants with clinically meaningful improvement (≥10 base-rate points) will be reported.
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1 year
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3. Biological Functioning Composite Score
Časové okno: 1 year
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Mean of Likert-scaled items assessing sleep quality, energy/motivation, physical health, exercise frequency, cognitive clarity and craving intensity (higher scores = better functioning).
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1 year
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Psychological Resilience Composite Score
Časové okno: 1 year
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Composite of mood stability, self-esteem trajectory, emotional processing, locus of control, trauma processing and self-forgiveness items, plus PHQ-9 total score (reverse-coded for resilience); higher composite = better psychological recovery.
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1 year
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Social Reintegration Composite Score
Časové okno: 1 year
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Family/partner relationships, number and quality of friendships, group support engagement, employment status and satisfaction, community/volunteer involvement and perceived support, averaged into a 1-5 composite.
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1 year
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Spiritual Well-Being Composite (FACIT-Sp-Adapted)
Časové okno: 1 year
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Items on purpose in life, peace, forgiveness, sense of connection, higher-power/transcendence, gratitude and spiritual practices; summed or averaged to provide a spiritual well-being score (0-32 or 1-5-scaled).
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1 year
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Self-Reported Relapse Events (Exploratory)
Časové okno: 1 year
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Number and severity of any alcohol use lapses/relapses, recorded via structured interview and group documentation, to explore associations with MCMI-IV patterns and serene versus struggle classification.
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1 year
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Alexandra M Gaina, MD, Grigore T Popa University of Medicine and Pharmacy PhD Department
- Studijní židle: Andreea S Szalontay, Clinical Professor, University of Medicine and Pharmacy "Grigore T. Popa" Iași Romania
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB 733/9.3.2026
- SER-ABS-AUD (Identifikátor registru: University of Medicine and Pharmacy Grigore T Popa PhD Department)
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