NCT Number: NCT07706660
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:
* Take part in 6 weekly group sessions (90 minutes each) of body-focused mindfulness, which includes breathing exercises, body scan, gentle movement, and group discussion. * Receive audio recordings of guided mindfulness exercises to practice independently between sessions. * Complete questionnaires about their emotions, body awareness, and alcohol craving before and after the program. * Be followed up at 4 weeks, 6 months, and 12 months after leaving the hospital to track their drinking.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Warsaw, Mazovian, 01-045, Poland
Andrzej Jakubczyk, MD, PhD
CONTACT
Andrzej Jakubczyk, MD, PhD
PRINCIPAL_INVESTIGATOR
Hubert Suszek, PhD
CONTACT
Hubert Suszek, PhD
SUB_INVESTIGATOR
Maciej Kopera, MD, PhD
SUB_INVESTIGATOR
Piotr Januszko, MD, PhD
SUB_INVESTIGATOR
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 (Kopera et al., 2025). 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 body map referring to their current bodily state. Between sessions, participants are asked to complete a body map when experiencing an episode of alcohol craving.
BODY MAPS Bodily sensation phenomenology is assessed using a paper-based body mapping measure adapted from the InteroMaps framework (Desmedt et al., 2025). Participants mark bodily regions on a printed body outline (front and back view) and rate overall intensity (0-10) and valence (-5 to +5). At T0 and T1, participants complete body maps for six emotions (anxiety, anger, shame, sadness, calm, happiness). After each session, participants complete a brief body map of their current bodily state. Between sessions, a body map is completed during episodes of alcohol craving, with additional ratings of craving intensity (0-10) and difficulty resisting (0-10).
SAMPLE SIZE Sample size was estimated based on Treves et al. (2025), a pre-registered meta-analysis of 29 RCTs (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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline and 6 weeks
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 (Mehling et al., 2018). Total score ranges from 0 to 185, with higher scores indicating greater interoceptive awareness (better outcome).
Time frame: Baseline and 6 weeks
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 scale comprises two independent subscales:
Time frame: Baseline and 6 weeks
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
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
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
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
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
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. Developed as a brief screening measure of mentalization capacity (Fonagy et al., 2016).
Time frame: Baseline and 6 weeks
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
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
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 scale consists of 7 pairs of circles (modified version of the Inclusion of Other in the Self Scale; Aron et al., 1992; Suszek et al., 2026). 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). Validated in AUD populations (Kopera et al., 2025).
Time frame: 4 weeks, 6 months, and 12 months post-discharge
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: Baseline and 6 weeks
The Body Maps - Bodily Sensation Phenomenology is a paper-based body mapping measure in which participants mark bodily regions associated with current emotional experience on a printed body outline (front and back view) and rate overall intensity (0-10, with higher scores indicating stronger bodily sensations) and valence (-5 to +5, with higher scores indicating more positive valence). Administered at baseline and post-intervention for eight states: six basic emotions (happiness, fear, anger, sadness, disgust, surprise), neutral state, and alcohol craving. Adapted from the InteroMaps framework (Desmedt et al., 2025).
Time frame: After each session, up to 6 weeks
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.
Contact information is provided by the study sponsor or research team.
Andrzej Jakubczyk, MD, PhD
CONTACT
Hubert Suszek, PhD
CONTACT
Medical University of Warsaw
Other
Effects of a Body-Focused Mindfulness Intervention Added to Standard Inpatient Alcohol Use Disorder Treatment on Emotion Regulation, Interoceptive Awareness, and Alcohol Craving: A Randomized Controlled Trial
Acronym: MBI-AUD-PL
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