Alcohol Use Disorder (AUD)MBI-AUD-PLNCT07706660
Body-Focused Mindfulness as an Add-on Intervention in Inpatient Alcohol Use Disorder Treatment (MBI-AUD-PL)
A study testing Body-Focused Mindfulness Intervention and Standard Psychoeducation in people with Alcohol Use Disorder (AUD) and Alcohol-Related Disorders, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD), Alcohol-Related Disorders
- What is being tested?
- Body-Focused Mindfulness Intervention and Standard Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Alcohol Use Disorder (DSM-5)
- Currently admitted to the inpatient AUD treatment program at the study ward
- Age 18 years or older
- Written informed consent provided
Who cannot join
- Refusal to participate or withdrawal of consent
- Severe somatic condition precluding participation in group activities
- Current acute psychotic symptoms
- Severe affective symptoms requiring intensive intervention
- High current suicide risk
- Epileptic seizure within 2 weeks prior to randomization
- Intellectual disability or significant cognitive impairment preventing understanding of or adherence to the study protocol
- Severe personality disorder with current self-harm or other-harm behaviors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Ward XVIII for Alcohol Use Disorder Treatment, Nowowiejski Hospital, Warsaw
Warsaw, Mazovian, 01-045
Andrzej Jakubczyk, MD, PhD, +48506647114, andrzej.jakubczyk@wum.edu.pl
Hubert Suszek, PhD, +48604202554, hubert.suszek@psych.uw.edu.pl
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Body-Focused Mindfulness Intervention, Standard Psychoeducation
- Keywords
- mindfulness, body-focused mindfulness, interoception, bodily dissociation, emotion regulation, alexithymia, inpatient treatment, alcohol use disorder, body awareness, randomized controlled trial
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders, Emotional Regulation, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-Focused Mindfulness InterventionBehavioural
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.
Standard PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Body-Focused Mindfulness | Experimental | 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. Receives: Behavioral: Body-Focused Mindfulness Intervention |
| Psychoeducation (Active Comparator) | Active comparator | 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. Receives: Behavioral: Standard Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 6 weeks
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 4 weeks, 6 months, and 12 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both groups receive the standard inpatient AUD treatment program (group psychotherapy, psychiatric care, and other therapeutic activities). The two groups differ only in one component: the experimental group receives 6 weekly 90-minute body-focused mindfulness sessions, while the active comparator group receives 6 weekly 90-minute standard psychoeducation sessions. All other treatment components are identical between groups.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warsaw
- Responsible party
- Principal investigator, Marcin Wojnar, Medical University of Warsaw
- Investigators
- Andrzej Jakubczyk, MD, PhD, Principal investigator, Medical University of WarsawMarcin Wojnar, MD, PhD, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706660
- Sponsor's protocol ID
- 2403/2026/09
- Acronym
- MBI-AUD-PL
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Desmedt O, Maurage P, Leganes-Fonteneau M, Billaux P, Billieux J. InteroMap: A Novel Tool to Map the Phenomenology of Bodily Sensations. PsyArXiv [Preprint]. 2025. doi: 10.31234/osf.io/qtudv.
Kopera M, Maurage P, Suszek H, Kobylinski P, Rydzewska M, Zaorska J, Trucco EM, Zawislak I, Caban W, Jakubczyk A. How identification with one's own body is related to emotional processes in individuals with alcohol use disorder. J Psychiatr Res. 2026 Jan;192:69-78. doi: 10.1016/j.jpsychires.2025.10.047. Epub 2025 Oct 22.
PubMed 41135251Aron A, Aron EN, Smollan D. Inclusion of Other in the Self Scale and the structure of interpersonal closeness. J Pers Soc Psychol. 1992;63(4):596-612. doi: 10.1037/0022-3514.63.4.596.
Treves IN, Chen YY, Wilson CL, Verdonk C, Qina Au J, Pustejovsky JE, Goldberg SB, Mehling W, Schuman-Olivier Z, Khalsa SS. A meta-analysis of the effects of mindfulness meditation training on self-reported interoception. Sci Rep. 2025 Nov 6;15(1):38889. doi: 10.1038/s41598-025-22661-4.
PubMed 41198766Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
PubMed 27392018Cheng SC, Thompson EA, Price CJ. The Scale of Body Connection: A Multisample Study to Examine Sensitivity to Change Among Mind-Body and Bodywork Interventions. J Integr Complement Med. 2022 Jul;28(7):600-606. doi: 10.1089/jicm.2021.0397. Epub 2022 Apr 22.
PubMed 35452263Price CJ, Thompson EA. Measuring dimensions of body connection: body awareness and bodily dissociation. J Altern Complement Med. 2007 Nov;13(9):945-53. doi: 10.1089/acm.2007.0537.
PubMed 18047441Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
PubMed 30513087
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07706660
- Acronym / sponsor ID
- MBI-AUD-PL / 2403/2026/09
- Keywords
- mindfulness, body-focused mindfulness, interoception, bodily dissociation, emotion regulation, alexithymia, inpatient treatment, alcohol use disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- University of Warsaw
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both groups receive the standard inpatient AUD treatment program (group psychotherapy, psychiatric care, and other therapeutic activities). The two groups differ only in one component: the experimental group receives 6 weekly 90-minute body-focused mindfulness sessions, while the active comparator group receives 6 weekly 90-minute standard psychoeducation sessions. All other treatment components are identical between groups.
| Arm | Type | Receives |
|---|---|---|
| Body-Focused Mindfulness | Experimental | Behavioral: Body-Focused Mindfulness InterventionParticipants 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. |
| Psychoeducation (Active Comparator) | Active comparator | Behavioral: Standard PsychoeducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Alcohol Use Disorder (DSM-5)
- Currently admitted to the inpatient AUD treatment program at the study ward
- Age 18 years or older
- Written informed consent provided
Key exclusion criteria (8 listed)
- Refusal to participate or withdrawal of consent
- Severe somatic condition precluding participation in group activities
- Current acute psychotic symptoms
- Severe affective symptoms requiring intensive intervention
- High current suicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body-Focused Mindfulness InterventionSix 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. | Behavioural | Body-Focused Mindfulness |
| Standard PsychoeducationSix 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. | Behavioural | Psychoeducation (Active Comparator) |
Primary outcome
Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) - total score
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. Total score ranges from 0 to 185, with higher scores indicating greater interoceptive awareness (better outcome).
11 secondary outcomes
Scale of Body Connection - Bodily Dissociation subscale (SBC-BD)
Time frame: Baseline and 6 weeks
Difficulties in Emotion Regulation Scale (DERS) - total score
Time frame: Baseline and 6 weeks
Toronto Alexithymia Scale (TAS-20) - total score
Time frame: Baseline and 6 weeks
Dissociative Experiences Scale (DES) - total score
Time frame: Baseline and 6 weeks
Penn Alcohol Craving Scale (PACS)
Time frame: Baseline and 6 weeks
Cognitive and Affective Mindfulness Scale Revised - Polish version (CAMS-R-PL)
Time frame: Baseline and 6 weeks
Reflective Functioning Questionnaire (RFQ)
Time frame: Baseline and 6 weeks
Beck Depression Inventory II (BDI-II)
Time frame: Baseline and 6 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline and 6 weeks
Self-Body Identification - Circles measure
Time frame: Baseline and 6 weeks
Timeline Follow-Back (TLFB) - alcohol use
Time frame: 4 weeks, 6 months, and 12 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- BackgroundDesmedt O, Maurage P, Leganes-Fonteneau M, Billaux P, Billieux J. InteroMap: A Novel Tool to Map the Phenomenology of Bodily Sensations. PsyArXiv [Preprint]. 2025. doi: 10.31234/osf.io/qtudv.
- Background: PubMed 41135251Kopera M, Maurage P, Suszek H, Kobylinski P, Rydzewska M, Zaorska J, Trucco EM, Zawislak I, Caban W, Jakubczyk A. How identification with one's own body is related to emotional processes in individuals with alcohol use disorder. J Psychiatr Res. 2026 Jan;192:69-78. doi: 10.1016/j.jpsychires.2025.10.047. Epub 2025 Oct 22.
- BackgroundAron A, Aron EN, Smollan D. Inclusion of Other in the Self Scale and the structure of interpersonal closeness. J Pers Soc Psychol. 1992;63(4):596-612. doi: 10.1037/0022-3514.63.4.596.
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- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrzej Jakubczyk, MD, PhD principal investigator
Medical University of Warsaw
Marcin Wojnar, MD, PhD study chair
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body-Focused Mindfulness Intervention and Standard Psychoeducation in people with Alcohol Use Disorder (AUD) and Alcohol-Related Disorders, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Jakubczyk, MD, PhD (+48506647114, andrzej.jakubczyk@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) - total score (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07706660, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.