NCT07706660

Brief 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. 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2029

First Submitted

Initial submission to the registry

June 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

June 15, 2026

Last Update Submit

July 11, 2026

Conditions

Keywords

mindfulnessbody-focused mindfulnessinteroceptionbodily dissociationemotion regulationalexithymiainpatient treatmentalcohol use disorderbody awarenessrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 (Mehling et al., 2018). Total score ranges from 0 to 185, with higher scores indicating greater interoceptive awareness (better outcome).

    Baseline and 6 weeks

Secondary Outcomes (11)

  • Scale of Body Connection - Bodily Dissociation subscale (SBC-BD)

    Baseline and 6 weeks

  • Difficulties in Emotion Regulation Scale (DERS) - total score

    Baseline and 6 weeks

  • Toronto Alexithymia Scale (TAS-20) - total score

    Baseline and 6 weeks

  • Dissociative Experiences Scale (DES) - total score

    Baseline and 6 weeks

  • Penn Alcohol Craving Scale (PACS)

    Baseline and 6 weeks

  • +6 more secondary outcomes

Other Outcomes (2)

  • Body Maps - Bodily Sensation Phenomenology (paper-based measure)

    Baseline and 6 weeks

  • Post-Session Single-Item Measures (three NRS items)

    After each session, up to 6 weeks

Study Arms (2)

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.

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.

Behavioral: Standard Psychoeducation

Interventions

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.

Body-Focused Mindfulness

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.

Psychoeducation (Active Comparator)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ward XVIII for Alcohol Use Disorder Treatment, Nowowiejski Hospital, Warsaw

Warsaw, Mazovian, 01-045, Poland

Location

Related Publications (4)

  • Cheng 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.

    PMID: 35452263BACKGROUND
  • Price 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.

    PMID: 18047441BACKGROUND
  • Mehling 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.

    PMID: 30513087BACKGROUND
  • Treves IN, Chen YY, Wilson CL, Verdonk C, Qina'au J, Pustejovsky JE, Goldberg SB, Mehling W, Schuman-Olivier Z, Khalsa SS. Minding the Body: A Meta-analysis of the Effects of Mindfulness Meditation Training on Self-reported Interoception. Res Sq [Preprint]. 2025 Jun 4:rs.3.rs-6792067. doi: 10.21203/rs.3.rs-6792067/v1.

    PMID: 40502790BACKGROUND

MeSH Terms

Conditions

AlcoholismAlcohol-Related DisordersEmotional RegulationAffective Symptoms

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSelf-ControlSocial BehaviorBehaviorBehavioral Symptoms

Study Officials

  • Andrzej Jakubczyk, MD, PhD

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR
  • Marcin Wojnar, MD, PhD

    Medical University of Warsaw

    STUDY CHAIR

Central Study Contacts

Andrzej Jakubczyk, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Psychiatry, Medical University of Warsaw

Study Record Dates

First Submitted

June 15, 2026

First Posted

July 16, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations