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NCT Number: NCT07561749

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

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.

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Key information

Conditions

Alcohol Abstinence Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Association of Recovering Alcoholics Don Orione

Iași, Iaşi, 707405, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Serene Abstinence Index at 12 Months (Binary: Serene vs Struggle Abstinence)

    Time frame: 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").

Secondary outcomes

  1. Change in MCMI-IV Personality and Clinical Syndrome Scales

    Time frame: 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.

  2. 3. Biological Functioning Composite Score

    Time frame: 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).

  3. Psychological Resilience Composite Score

    Time frame: 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.

  4. Social Reintegration Composite Score

    Time frame: 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.

  5. Spiritual Well-Being Composite (FACIT-Sp-Adapted)

    Time frame: 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).

  6. Self-Reported Relapse Events (Exploratory)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Grigore T. Popa University of Medicine and Pharmacy

Other

Collaborators

  • Association of Alcoholics in Recovery Clubs Don Orione

Registry information

Official study 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)

Acronym: SER-ABS-AUD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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