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

May 2, 2026 updated by: Marcel-Alexandru Gaina, Grigore T. Popa University of Medicine and Pharmacy

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Iaşi
      • Iași, Iaşi, Romania, 707405
        • Association of Recovering Alcoholics Don Orione

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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).
1 year
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.
1 year
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.
1 year
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).
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexandra M Gaina, MD, Grigore T Popa University of Medicine and Pharmacy PhD Department
  • Study Chair: Andreea S Szalontay, Clinical Professor, University of Medicine and Pharmacy "Grigore T. Popa" Iași Romania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 20, 2027

Study Registration Dates

First Submitted

April 19, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB 733/9.3.2026
  • SER-ABS-AUD (Registry Identifier: University of Medicine and Pharmacy Grigore T Popa PhD Department)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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