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| ID | Type | Description | Link |
|---|---|---|---|
| SER-ABS-AUD | Registry Identifier | University of Medicine and Pharmacy Grigore T Popa PhD Department |
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| Name | Class |
|---|---|
| Association of Alcoholics in Recovery Clubs Don Orione | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MCMI-IV Personality and Clinical Syndrome Scales | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Andreea S Szalontay, Clinical Professor | 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Association of Recovering Alcoholics Don Orione | Iași | Iaşi | 707405 | Romania |
Individual participant data will not be shared. This is an observational study with minimal-risk psychological assessments involving sensitive personal information (psychiatric history, spiritual beliefs, recovery experiences) from a vulnerable population (adults with alcohol use disorder). GDPR Article 9 restricts sharing of special category data without explicit participant consent for third-party access, which was not obtained. De-identified summary statistics and aggregate findings will be published in peer-reviewed journals per ICMJE requirements.
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| ID | Term |
|---|---|
| D064829 | Alcohol Abstinence |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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| 3. Biological Functioning Composite Score | Mean of Likert-scaled items assessing sleep quality, energy/motivation, physical health, exercise frequency, cognitive clarity and craving intensity (higher scores = better functioning). | 1 year |
| Psychological Resilience Composite Score | 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. | 1 year |
| Social Reintegration Composite Score | 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. | 1 year |
| Spiritual Well-Being Composite (FACIT-Sp-Adapted) | 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). | 1 year |
| Self-Reported Relapse Events (Exploratory) | 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. | 1 year |
| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |