Alcohol Use Disorder (AUD)SER-ABS-AUDNCT07561749
SER-ABS-AUD: Neuropsychosocial-Spiritual Correlates of Serene Abstinence in Adults With AUD
An observational study of Alcohol Use Disorder (AUD) and Alcohol Abstinence, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
SER-ABS-AUD is a single-centre, non-interventional, mixed retrospective-prospective longitudinal cohort study of 70 adults aged 18-70 years with documented alcohol use disorder, at least 12 consecutive months of continuous alcohol abstinence before enrolment, and an archived pre-enrolment MCMI-IV profile. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD), Alcohol Abstinence
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteRomania
- Study dates
- 20 Apr 2026to 20 Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18-70 years with documented alcohol use disorder according to DSM-5-TR or ICD-10 criteria, at least 12 consecutive months of continuous alcohol abstinence before enrolment/current T2 assessment, and an archived pre-enrolment MCMI-IV profile available for retrospective extraction. Participants are recruited consecutively from ACAR Don Orione services and affiliated support groups in Iași or identified through affiliated Institute of Psychiatry Socola referral pathways. The cohort consists of individuals already engaged in a community-based recovery context; the study does not assign, modify, or standardize usual care.
Who may be able to join
- Age 18-70 years.
- Documented history of alcohol use disorder according to DSM-5-TR or ICD-10 diagnostic criteria.
- At least 12 consecutive months of continuous alcohol abstinence before enrolment/current T2 assessment. Any alcohol consumption interrupts continuous abstinence and restarts the qualifying 12-month interval from the date of last use. Abstinence is established by structured self-report and, where available and consented to, corroborated by clinical notes or Club-facilitator documentation.
- Archived pre-enrolment MCMI-IV profile available for retrospective extraction.
- Ability to understand study procedures and provide written informed consent in Romanian.
Who cannot join
- Acute psychiatric condition requiring emergency intervention at screening, including acute psychosis or mania.
- Current uncontrolled non-alcohol substance use disorder, defined as ongoing use associated with intoxication or withdrawal, urgent treatment need, marked functional impairment, or investigator judgment that reliable consent or study completion would be compromised.
- Legal incapacity or inability to provide written informed consent.
- Severe cognitive impairment or communication difficulty that, in the screening clinician's judgment, precludes valid consent or reliable completion of study procedures.
- Historical or stable treated nicotine use, prescribed medication use, or a non-alcohol substance use disorder in sustained remission does not constitute automatic exclusion. A response other than 'not at all' to PHQ-9 item 9 triggers immediate clinical suicide-risk assessment and the local safety pathway; it is not, by itself, an automatic exclusion criterion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Association of Recovering Alcoholics Don Orione
Iași, Iaşi, 707405
About this study
Official title: Neuropsychosocial-Spiritual Correlates of Serene Abstinence in Adults With Alcohol Use Disorder Receiving Community-Based Recovery Care in Romania: A Longitudinal Observational Study Protocol (SER-ABS-AUD)
SER-ABS-AUD is a single-centre, non-interventional, mixed retrospective-prospective longitudinal cohort study of 70 adults aged 18-70 years with documented alcohol use disorder, at least 12 consecutive months of continuous alcohol abstinence before enrolment, and an archived pre-enrolment MCMI-IV profile. After written informed consent at the current T2 enrolment visit, archived T1 MCMI-IV data and eligible clinical information are extracted, and the MCMI-IV plus a supplementary recovery-outcome battery are administered prospectively at T2. The primary outcome is within-person change in prespecified MCMI-IV scales between archived T1 and current T2. The secondary exploratory Serene Abstinence Index combines change in MCMI-IV Persistent Depression with current T2 natural reward response, spiritual well-being, and quality of life. T2-only measures are interpreted as current outcomes or concurrent exploratory correlates, not longitudinal change. No experimental intervention or post-enrolment 12-month follow-up is included.
Read the detailed description
SER-ABS-AUD examines multidimensional recovery among adults with alcohol use disorder receiving community-based recovery support in Iași, Romania. It is a single-centre, non-interventional cohort study with mixed retrospective and prospective data collection.
Archived T1 is a pre-enrolment MCMI-IV assessment collected during routine care. Current T2 is the single research enrolment visit, performed after the participant has completed at least 12 consecutive months of continuous alcohol abstinence. Following written informed consent, the archived T1 MCMI-IV profile and eligible clinical information are extracted retrospectively. At the same T2 enrolment visit, participants complete the MCMI-IV and the supplementary recovery-outcome battery. The actual interval between T1 and T2 is recorded for each participant. No additional 12-month post-enrolment visit is undertaken.
The primary longitudinal outcome is within-person change in prespecified MCMI-IV base-rate scores: Persistent Depression (D), Generalized Anxiety (A), Avoidant personality pattern (2A), Dependent personality pattern (3), and Masochistic personality pattern (8B). Alcohol Use (B) is retained primarily as a descriptive indicator. The same instrument is used at T1 and T2, although assessment context may differ; available metadata on date, setting, assessor, scoring workflow, completion, and validity indicators are summarized and considered in sensitivity analyses.
The Serene Abstinence Index is a secondary, investigator-defined exploratory composite among participants who already meet the 12-month abstinence eligibility criterion. Strict SAI status requires all four criteria: (1) archived T1 MCMI-IV Persistent Depression score ≥75 BR, current T2 score ≤60 BR, and reduction ≥15 BR points; (2) T2 natural reward response ≥4 on a 1-5 item; (3) T2 adapted eight-item spiritual well-being score ≥26/32; and (4) T2 Quality of Life Inventory total score ≥3.6. Sensitivity analyses examine at least three of four criteria, individual components, and a continuous composite if finalized before database lock. The SAI is not a diagnostic category, validated endpoint, or clinical prediction tool.
PHQ-9, QoLI, SWLS, MOS Social Support Survey, MMSE, the adapted eight-item spiritual-well-being item set, natural reward response, and the purpose-built biological, psychological, social, and spiritual domain scores are administered at T2 only. They are analyzed as current outcomes or concurrent exploratory correlates and are not represented as T1-T2 changes. Variables included in the SAI are not entered as predictors of that same composite. Subject to event-count criteria, a restricted Firth penalized logistic model will examine associations of strict SAI status with archived T1 Generalized Anxiety, archived T1 Avoidant personality-pattern score, and duration of continuous abstinence before enrolment. Results will be interpreted as exploratory associations without causal or clinical-prediction claims.
The study does not assign or modify treatment. Participants continue usual ACAR Don Orione recovery care. Continuous alcohol abstinence is an eligibility criterion rather than a prospective relapse outcome. Pre-enrolment recovery history may be described retrospectively, but no relapse incidence is estimated during a post-enrolment follow-up.
- Conditions
- Alcohol Use Disorder (AUD), Alcohol Abstinence
- Keywords
- Alcohol use disorder, Serene abstinence, Struggle abstinence, MCMI-IV, Support groups, Romania
- Medical subject headings
- Alcoholism, Alcohol Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sustained Abstinence Cohort | Adults with documented alcohol use disorder who have completed at least 12 consecutive months of continuous alcohol abstinence before enrolment and have an archived pre-enrolment MCMI-IV profile. Archived routine-care T1 data are extracted after consent, and the MCMI-IV plus supplementary recovery-outcome measures are administered at the current T2 enrolment visit. No experimental intervention is delivered and no post-enrolment follow-up visit is undertaken; usual ACAR Don Orione recovery care continues independently of the research protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-Participant Change in Prespecified MCMI-IV Base-Rate Scores
Within-participant difference between archived routine-care T1 and current research T2 base-rate scores for MCMI-IV Persistent Depression (D), Generalized Anxiety (A), Avoidant personality pattern (2A), Dependent personality pattern (3), and Masochistic personality pattern (8B). T1, T2, paired change, 95% confidence intervals, and standardized paired effect sizes will be reported. Paired t-tests or Wilcoxon signed-rank tests will be used according to distributional properties. Alcohol Use (B) will be reported descriptively. Available assessment-context variables and the actual T1-T2 interval will be described.
Measured: Archived pre-enrolment T1 assessment to current T2 enrolment visit; participant-specific interval recorded.
Secondary outcomes (12)
Strict Exploratory Serene Abstinence Index Status
Binary strict SAI status at current T2, requiring all four criteria: (1) archived T1 MCMI-IV Persistent Depression (D) ≥75 BR, current T2 D ≤60 BR, and reduction ≥15 BR points; (2) T2 natural reward response ≥4 on a 1-5 item; (3) T2 adapted eight-item spiritual well-being score ≥26/32; and (4) T2 Quality of Life Inventory total score ≥3.6. Exact 95% confidence intervals will be reported. Sensitivity analyses will examine fulfilment of at least three of four criteria, individual components, and a continuous composite if prespecified before database lock. The SAI is exploratory and unvalidated.
Measured: Archived pre-enrolment T1 assessment and current T2 enrolment visit; SAI classified at T2.
T2 Biological-Functioning Domain Score
Mean of eligible Likert items assessing sleep quality, energy and motivation, self-rated physical functioning, exercise frequency, cognitive clarity, and craving intensity. Negatively phrased items are reverse-coded so higher scores indicate better current functioning. A domain mean is calculated when at least 80% of constituent items are complete.
Measured: Current T2 enrolment visit; single assessment.
T2 Psychological-Functioning Domain Score
Mean of eligible Likert items assessing current mood stability, self-esteem, emotional processing, locus of control, resilience to triggers, shame, self-forgiveness, and trauma processing. Item direction is harmonized so higher scores indicate better current functioning. A domain mean is calculated when at least 80% of constituent items are complete. The score is interpreted alongside, but separately from, PHQ-9.
Measured: Current T2 enrolment visit; single assessment.
T2 Social-Reintegration Domain Score
Mean of eligible Likert items assessing current family or partner relationships, friendship quantity and quality, employment status and satisfaction, support-group involvement, and community or volunteer participation. Item direction is harmonized so higher scores indicate better current functioning. A domain mean is calculated when at least 80% of constituent items are complete.
Measured: Current T2 enrolment visit; single assessment.
T2 Spiritual Domain Score
Mean of eligible purpose-built Likert items assessing current purpose in life, values alignment, hope, prayer or meditation, spiritual-community involvement, connection with nature, transcendence, inner peace, forgiveness, gratitude, and religious or spiritual doubt or trauma. Item direction is harmonized so higher scores indicate better current functioning. This score is separate from the adapted eight-item spiritual-well-being score.
Measured: Current T2 enrolment visit; single assessment.
T2 Adapted Eight-Item Spiritual-Well-Being Score
Total score from an investigator-adapted eight-item spiritual-well-being item set, each item scored 0-4; range 0-32, with higher scores indicating greater current spiritual well-being. This exploratory item set is not the complete validated FACIT-Sp instrument. The total score and distribution will be reported; ≥26/32 is the exploratory SAI component threshold.
Measured: Current T2 enrolment visit; single assessment.
T2 Quality of Life Inventory Total Score
Current subjective quality of life measured using the Quality of Life Inventory (QoLI) total score. The continuous total score and distribution will be reported; ≥3.6 is the exploratory SAI component threshold. QoLI is measured only at T2 and is not interpreted as within-participant quality-of-life improvement.
Measured: Current T2 enrolment visit; single assessment.
T2 Satisfaction With Life Scale Total Score
Current life satisfaction measured with the Satisfaction With Life Scale (SWLS) total score and summarized as a continuous T2 outcome.
Measured: Current T2 enrolment visit; single assessment.
T2 MOS Social Support Survey Score
Current perceived social support measured with the Medical Outcomes Study Social Support Survey (MOS-SSS) score and summarized as a continuous T2 outcome.
Measured: Current T2 enrolment visit; single assessment.
T2 Patient Health Questionnaire-9 Total Score
Current depressive symptom burden measured with the PHQ-9 total score and summarized as a continuous T2 outcome. Any response other than "not at all" to item 9 triggers immediate clinical assessment under the local suicide-risk procedure.
Measured: Current T2 enrolment visit; single assessment.
T2 Mini-Mental State Examination Score
Current global cognitive screening measured with the MMSE total score. MMSE is analyzed as an exploratory clinical variable and is not interpreted as a diagnostic assessment of alcohol-related neurocognitive disorder.
Measured: Current T2 enrolment visit; single assessment.
T2 Natural Reward Response Score
Single 1-5 Likert item assessing enjoyment of ordinary non-alcohol-related activities, with higher scores indicating greater current capacity to experience pleasure from everyday natural rewards. The continuous item score will be reported; ≥4 is the exploratory SAI component threshold.
Measured: Current T2 enrolment visit; single assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start20 Apr 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Alcoholics in Recovery Clubs Don Orione
- Responsible party
- Principal investigator, Marcel-Alexandru Gaina, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Andreea S Szalontay, Clinical Professor, Study chair, University of Medicine and Pharmacy "Grigore T. Popa" Iași RomaniaAlexandra M Gaina, MD, Principal investigator, Grigore T Popa University of Medicine and Pharmacy PhD Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561749
- Sponsor's protocol ID
- IRB 733/9.3.2026
- Other IDs
- SER-ABS-AUD
- Acronym
- SER-ABS-AUD
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level data will not be publicly shared because the dataset contains sensitive special-category personal data, including psychiatric history and recovery-related psychosocial information, collected from a vulnerable population. The participant-information and consent procedures and the study's ethical and data-governance arrangements do not permit third-party sharing of individual-level data. De-identified aggregate results and summary statistics will be reported in peer-reviewed publications. Requests for clarification regarding study data or additional aggregate analyses may be directed to the corresponding author.