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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Iaşi
-
Iași, Iaşi, Romania, 707405
- Association of Recovering Alcoholics Don Orione
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Serene Abstinence Index at 12 Months (Binary: Serene vs Struggle Abstinence)
Aikaikkuna: 1 year
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in MCMI-IV Personality and Clinical Syndrome Scales
Aikaikkuna: 1 year
|
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
|
|
3. Biological Functioning Composite Score
Aikaikkuna: 1 year
|
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
Aikaikkuna: 1 year
|
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
Aikaikkuna: 1 year
|
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)
Aikaikkuna: 1 year
|
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)
Aikaikkuna: 1 year
|
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
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Alexandra M Gaina, MD, Grigore T Popa University of Medicine and Pharmacy PhD Department
- Opintojen puheenjohtaja: Andreea S Szalontay, Clinical Professor, University of Medicine and Pharmacy "Grigore T. Popa" Iași Romania
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- IRB 733/9.3.2026
- SER-ABS-AUD (Rekisterin tunniste: University of Medicine and Pharmacy Grigore T Popa PhD Department)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .