An interventional study of Body-Focused Mindfulness Intervention and Standard Psychoeducation in Alcohol Use Disorder (AUD) and Alcohol-Related Disorders, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if a body-focused mindfulness program can help people with alcohol use disorder (AUD) feel more connected to their bodies and manage their emotions better. The main questions it aims to answer are:
Does the mindfulness program reduce feelings of disconnection from the body (bodily dissociation)? Does it improve awareness of body signals (interoceptive awareness)? Does it lower alcohol craving and reduce the chance of returning to drinking after leaving the hospital? Researchers will compare participants who receive the mindfulness program to participants who receive standard psychoeducation sessions, within the same overall inpatient AUD treatment program.
Participants will:
BACKGROUND Alcohol use disorder (AUD) is associated with impaired interoceptive awareness, bodily dissociation, alexithymia, and emotion dysregulation. These deficits are linked to elevated craving and relapse risk. Impaired body-self integration - the degree to which individuals identify with their own body - has been documented in AUD and is associated with emotional processing difficulties. While mindfulness-based interventions have shown promise in AUD treatment, programs targeting bodily experience without direct reference to substance use have not been systematically evaluated in inpatient settings.
INTERVENTION The body-focused mindfulness intervention consists of 6 weekly 90-minute group sessions added to standard inpatient AUD treatment. Each session follows a structured format: check-in and review of home practice (10 min), breath-focused meditation (10 min), psychoeducation on mindfulness attitudes (15 min), main body-focused practice - body scan in lying or seated position, mindful walking and stretching (20 min), structured inquiry (15 min), weekly intention setting and home practice assignment (10 min), and 3-minute breathing space (5 min). Participants receive audio recordings of guided mindfulness exercises and are encouraged to practice independently (5-10 minutes daily) between sessions. The intervention does not include direct reference to alcohol use or relapse prevention content. Sessions are delivered by therapists trained in mindfulness-based approaches with personal meditation practice experience.
STRUCTURED INQUIRY Each session includes a structured inquiry component in which the therapist facilitates exploration of participants' bodily experience during practice through open, non-judgmental questions. Inquiry is anchored to bodily experience - the therapist actively returns the conversation to somatic sensations when participants shift toward narrative or abstract reflection.
CONTROL CONDITION The active comparator group receives 6 weekly 90-minute psychoeducation sessions added to the same standard inpatient AUD treatment. Sessions cover standard topics related to alcohol use disorder, recovery, and coping strategies. Delivered by the same therapists as the experimental group. All other components of the inpatient treatment program are identical between groups.
RANDOMIZATION Randomization occurs after 14 days of hospitalization, following completion of the standard introductory psychoeducation program. Computer-generated randomization with sequentially numbered sealed envelopes is used for allocation concealment. Randomization is performed by a person not involved in the delivery of the intervention or outcome assessment.
ASSESSMENT All assessments are conducted in paper-and-pencil format at five time points: baseline (T0, after 14 days of hospitalization, before randomization), post-intervention (T1, before discharge, approximately 6 weeks after T0), and follow-up at 4 weeks (T2), 6 months (T3), and 12 months (T4) post-discharge. After each session, participants in both groups complete a brief paper-based questionnaire consisting of three numeric rating scale items (0-10) covering mindful awareness during the session, clarity of bodily sensations during the session, and current alcohol craving.
BODY MAPS Bodily sensation phenomenology is assessed using a paper-based body mapping measure adapted from the InteroMaps framework. Participants mark bodily regions on printed body outlines (front and back views of the whole body and of the head), indicating the intensity of sensations by the number of crosses placed in a region (1 = very weak to 5 = very strong) and rating the pleasantness of each marked sensation on a 1 to 7 scale (1 = very unpleasant, 4 = neutral, 7 = very pleasant). At T0 and T1, participants complete body maps for eight states: happiness, fear, anger, sadness, disgust, surprise, shame, and a neutral state.
SAMPLE SIZE Sample size was estimated based on a pre-registered meta-analysis of 29 randomized controlled trials (N=2,191) examining the effects of mindfulness-based interventions on self-reported interoception (primary outcome: MAIA-2 total score). The pooled effect across all mindfulness interventions was g=0.31 (95% CI [0.21, 0.42]); the effect for mindfulness-based programs incorporating body scan, breath awareness, mindful movement, and inquiry was g=0.41 (95% CI [0.29, 0.54]). Adopting g=0.41 as the primary assumption, with alpha=0.05 (two-tailed) and 80% statistical power, the required sample is 95 participants per group (N=190 total). Accounting for an anticipated 20% dropout rate, the adjusted target is 119 per group. The planned sample of N=240 (120 per group) provides 80% power at g=0.41 after accounting for dropout, with additional margin for feasibility.
FEASIBILITY REVIEW After enrollment of 100 participants, a feasibility review will assess recruitment rate, protocol adherence, and dropout rate. No interim efficacy analysis is planned. Sample size may be revised upward based on observed attrition. Recruitment will continue beyond N=240 if feasible within the planned recruitment period.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 240 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard inpatient AUD treatment plus 6 weekly 90-minute body-focused mindfulness group sessions (breath awareness, body scan, mindful movement, and structured inquiry). Sessions are delivered in an open circular group format without direct reference to alcohol use. Participants receive audio recordings of guided mindfulness exercises and are encouraged to practice independently (5-10 minutes daily) between sessions.
Behavioral: Body-Focused Mindfulness Intervention
Participants receive standard inpatient AUD treatment plus 6 weekly 90-minute psychoeducation group sessions covering standard topics related to alcohol use disorder, recovery, and coping strategies. All other components of the treatment program are identical to the experimental group.
Behavioral: Standard Psychoeducation
Six weekly 90-minute group sessions incorporating breath-focused meditation, body scan (lying and seated positions), mindful movement and stretching, and structured inquiry. Delivered in an open circular group format by therapists trained in mindfulness-based approaches. No direct reference to alcohol use. Participants receive audio recordings of guided mindfulness exercises and are encouraged to practice independently (5-10 minutes daily) between sessions.
Six weekly 90-minute group psychoeducation sessions added to standard inpatient AUD treatment. Sessions cover standard topics related to alcohol use disorder, recovery, and coping strategies. Delivered by the same therapists as the experimental group. All other components of the inpatient treatment program are identical between groups.
Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) - total score
The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) is a 37-item self-report questionnaire assessing eight dimensions of interoceptive awareness including noticing, attention regulation, emotional awareness, self-regulation, body listening, and trusting bodily sensations. Total score ranges from 0 to 185, with higher scores indicating greater interoceptive awareness (better outcome).
Time frame: Baseline and 6 weeks
Scale of Body Connection - Bodily Dissociation subscale (SBC-BD)
The Scale of Body Connection (SBC) is a 20-item measure on a 5-point Likert scale (1 = "not at all" to 5 = "all of the time") assessing bodily experience. The Bodily Dissociation subscale (SBC-BD) comprises 8 items, with total scores ranging from 8 to 40; higher scores indicate greater bodily dissociation (worse outcome). The SBC is specifically designed for mind-body intervention research and shows good construct validity and sensitivity to change in mindfulness interventions.
Time frame: Baseline and 6 weeks
Difficulties in Emotion Regulation Scale (DERS) - total score
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report questionnaire measuring difficulties in emotion regulation across six dimensions: non-acceptance of emotional responses, difficulty engaging in goal-directed behaviors, impulse control difficulties, lack of emotional awareness, limited access to regulation strategies, and lack of emotional clarity. Total score ranges from 36 to 180, with higher scores indicating greater difficulties in emotion regulation (worse outcome).
Time frame: Baseline and 6 weeks
Toronto Alexithymia Scale (TAS-20) - total score
The Toronto Alexithymia Scale (TAS-20) is a 20-item self-report measure of alexithymia assessing three dimensions: difficulty identifying feelings, difficulty describing feelings, and externally oriented thinking. Total score ranges from 20 to 100, with higher scores indicating greater alexithymia (worse outcome).
Time frame: Baseline and 6 weeks
Dissociative Experiences Scale (DES) - total score
The Dissociative Experiences Scale (DES) is a 28-item self-report measure of the frequency of dissociative experiences. Total score ranges from 0 to 100, with higher scores indicating greater frequency of dissociation (worse outcome).
Time frame: Baseline and 6 weeks
Penn Alcohol Craving Scale (PACS)
The Penn Alcohol Craving Scale (PACS) is a 5-item self-report measure assessing alcohol craving frequency, intensity, duration, and ability to resist. Total score ranges from 0 to 30, with higher scores indicating greater alcohol craving (worse outcome).
Time frame: Baseline and 6 weeks
Cognitive and Affective Mindfulness Scale Revised - Polish version (CAMS-R-PL)
The Cognitive and Affective Mindfulness Scale-Revised Polish version (CAMS-R-PL) is a 10-item self-report measure on a 4-point Likert scale (1 = Rarely/Never, 2 = Sometimes, 3 = Often, 4 = Almost Always) assessing present-moment awareness, attention, intention, and non-judgment as a unidimensional construct of dispositional mindfulness. Total score ranges from 10 to 40, with higher scores indicating greater dispositional mindfulness (better outcome).
Time frame: Baseline and 6 weeks
Reflective Functioning Questionnaire (RFQ)
The Reflective Functioning Questionnaire (RFQ) is an 8-item self-report measure assessing reflective functioning across two subscales: Certainty about mental states (RFQ-C, higher scores indicate hypermentalizing) and Uncertainty about mental states (RFQ-U, higher scores indicate hypomentalizing). Both subscales use a recoded scoring procedure. Higher scores on either subscale indicate more maladaptive mentalizing. The RFQ was developed as a brief screening measure of mentalization capacity.
Time frame: Baseline and 6 weeks
Beck Depression Inventory II (BDI-II)
The Beck Depression Inventory II (BDI-II) is a 21-item self-report measure of depression severity over the past two weeks. Total score ranges from 0 to 63, with higher scores indicating greater depressive symptoms (worse outcome).
Time frame: Baseline and 6 weeks
State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) measures state anxiety (current anxiety level) and trait anxiety (general tendency to experience anxiety). Each subscale ranges from 20 to 80, with higher scores indicating greater state or trait anxiety (worse outcome).
Time frame: Baseline and 6 weeks
Self-Body Identification - Circles measure
The Self-Body Identification - Circles measure is a visual measure of the degree of psychological identification of the self with one's own body, using overlapping circles to represent the perceived overlap between self and body. The measure consists of 7 pairs of circles and is a modified version of the Inclusion of Other in the Self Scale. Total score ranges from 1 (lowest level of identification with the body) to 7 (highest level of identification with the body), with higher scores indicating stronger self-body identification (better outcome). The measure has previously been used in clinical samples, including individuals with alcohol use disorder.
Time frame: Baseline and 6 weeks
Timeline Follow-Back (TLFB) - alcohol use
The Timeline Follow-Back (TLFB) is a structured retrospective interview assessing daily alcohol use over a specified period. Outcomes include percentage of days abstinent (PDA, ranging from 0 to 100%) and mean drinks per drinking day (MDDD, ranging from 0 upward), with higher abstinence and lower MDDD indicating better clinical outcome. Used to assess alcohol consumption and relapse patterns after hospital discharge. Primary follow-up outcome for long-term clinical effectiveness.
Time frame: 4 weeks, 6 months, and 12 months post-discharge
Body Maps - Bodily Sensation Phenomenology (paper-based measure)
The Body Maps - Bodily Sensation Phenomenology is a paper-based body mapping measure in which participants mark, on printed body outlines (front and back views of the whole body and of the head), the bodily regions where they typically experience sensations when experiencing a given emotion or state. The intensity of sensations in each marked region is indicated by the number of crosses placed there, from 1 (very weak sensation) to 5 (very strong sensation). For each marked region participants also rate pleasantness on a 1 to 7 scale (1 = very unpleasant, 4 = neutral, 7 = very pleasant), with higher scores indicating more pleasant sensations. Administered at baseline and post-intervention for eight states: happiness, fear, anger, sadness, disgust, surprise, shame, and a neutral state.
Time frame: Baseline and 6 weeks
Post-Session Single-Item Measures (three NRS items)
Three single-item Numeric Rating Scale (NRS) measures, each ranging from 0 to 10, are administered immediately after each session to participants in both groups. Item 1 assesses mindful awareness (0 = not at all able to notice what was happening inside them, 10 = fully able to notice; higher scores indicate better outcome). Item 2 assesses interoceptive awareness (0 = did not feel their body at all clearly, 10 = felt their body very clearly; higher scores indicate better outcome). Item 3 assesses current alcohol craving (0 = not at all craving alcohol, 10 = unbearably craving; higher scores indicate worse outcome). Items 1 and 2 refer to the session experience (retrospective), while Item 3 refers to the current moment (post-session state). Administered to both groups to allow direct comparison of session effects between body-focused mindfulness and psychoeducation conditions.
Time frame: After each session, up to 6 weeks
Plan to share: No — Individual participant data will not be shared publicly due to ethical considerations related to sensitive clinical data, including alcohol use disorder diagnosis, psychiatric history, and trauma history. Aggregate data and study materials will be available upon reasonable request to the corresponding author following publication.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 29 months is below that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
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