NCT07495839

Brief Summary

Addiction is a major public health issue. According to the World Health Organization (2024), approximately 400 million people worldwide suffer from alcohol- or drug-related disorders, resulting in nearly 3.2 million deaths per year. In France, the situation is also cause for concern: approximately three million people engage in risky alcohol consumption, thirteen million smoke daily, and nearly one and a half million use illicit drugs, primarily cannabis. Addiction, defined by the National Institute on Drug Abuse (NIDA) as a chronic, relapsing brain disorder, is characterized by the compulsive pursuit and use of a substance despite knowledge of its harmful effects. Its development depends on multiple factors: personal (trauma, psychiatric disorders, genetic predispositions), environmental (stress, isolation, family context), and those related to the substance itself (addictive potential). The diagnosis of substance use disorders is based on 11 criteria defined in the \*Diagnostic and Statistical Manual of Mental Disorders\* (DSM-5), the main ones being: loss of self-control, interference of substance use with academic or occupational activities, continued use despite awareness of the problems it causes, and a new central criterion, craving, defined as an irresistible urge to use, which serves as both a symptom and a diagnostic and prognostic marker because it is a predictor of relapse. The cumulative total of criteria allows the disorder to be classified as mild (2-3), moderate (4-5), or severe (≤ 6). Since the 2020 health crisis, researchers have observed an increase in the use of psychoactive substances, particularly among vulnerable populations. Despite public policy efforts and treatment programs, relapses remain common after treatment, affecting 60 to 70% of patients within six months of their hospitalization. This phenomenon is also observed at La Musse Hospital, where many patients admitted to the nutrition and alcoholism unit express a sense of emptiness upon returning home: a void in relationships, therapy, and daily activities. This feeling often contributes to a return to substance use. To address these relapses, this study aims to evaluate the impact of a post-hospitalization equine-assisted therapy program on the mental health and addictive behaviors of patients receiving addiction treatment. Already used at La Musse Hospital as part of the care pathway, equine-assisted therapy is based on the interaction between the patient and the horse in a therapeutic setting. Several studies have demonstrated the benefits of this approach on emotional regulation, self-confidence, stress management, and overall well-being. This prospective, single-center, interventional study will include twenty-two patients who have been hospitalized at least once in the nutrition and alcoholism unit at La Musse Hospital or another facility. Participants will be randomly assigned to either a group receiving post-hospitalization equine-assisted therapy or a control group.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
26mo left

Started Apr 2026

Typical duration for not_applicable

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 Progress9%
Apr 2026Aug 2028

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 23, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Equine mediationAddictionRecidivismAddictive behaviorMental health

Outcome Measures

Primary Outcomes (1)

  • The score on the Craving Experience Questionnaire

    The score on the Craving Experience Questionnaire (CEQ-F). This questionnaire retrospectively assesses the intensity and frequency of cravings over a specific time period. The CEQ allows for the assessment of cravings for a variety of substances, including alcohol, cigarettes, drugs, or food. The CEQ exhibits excellent psychometric properties (May et al., 2014). This questionnaire enables the calculation of a craving intensity score for a specific substance or food based on the 11 intensity items. Each item is rated on a scale from 0 ("Not at all") to 10 ("Extremely"). Summing these 11 scores yields a total craving intensity score ranging from 0 to 110. The higher the score, the more intense the participant's craving is considered to be. Additionally, the craving frequency score obtained by the CEQ can be calculated by adding the values obtained for the 11 items corresponding to frequency. Each item in this section is rated on a

    at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.

Secondary Outcomes (7)

  • The total score on the Beck Depression Inventory

    at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.

  • The total score on the Beck Anxiety Inventory

    at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.

  • The number of relapses

    Each week, up to 37 weeks

  • The number, intensity, and duration of self-reported cravings

    Each week, up to 37 weeks

  • Scores on the WHOQOL-BREF quality of life questionnaire

    at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.

  • +2 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients in the experimental group will receive 22 sessions of equine-assisted therapy over a 24-week period

Other: Equine mediation

Control Group

NO INTERVENTION

Patients in the control group will not receive equine-assisted therapy sessions but will only undergo various follow-up assessments

Interventions

Patients in the experimental group will receive 22 sessions of equine-assisted therapy over a 24-week period (Figure 2). The objective of this protocol is to provide a phased transition toward a gradual return to their daily lives. To this end, two equine-assisted therapy sessions per week will be conducted for 1 month (8 sessions), followed by one session per week for 2 months (8 sessions), and finally one session every two weeks for 3 months (6 sessions). Each session will last 1 hour and 30 minutes, with groups of 4 patients, led by 2 professionals from the equine therapy center at La Musse Hospital.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Adult patients over the age of 18,
  • Patients who have completed detoxification and have been hospitalized at least once in the nutrition and alcoholism unit at La Musse Hospital or at another facility,
  • Patients with an addiction to a psychoactive substance (e.g., alcohol, tobacco, cannabis),
  • Able to participate in animal-assisted therapy sessions,
  • Ability to understand instructions during sessions,
  • Enrolled in the social security system.

You may not qualify if:

  • Patients with a behavioral addiction not involving substances (e.g., gambling, sexual addiction),
  • Patients who have not yet completed detoxification,
  • Patients under legal guardianship,
  • Patients currently undergoing other animal-assisted therapy,
  • Allergies to horses,
  • Other serious medical conditions that may interfere with participation in the sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior, AddictiveRecidivismPsychological Well-Being

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorCriminal BehaviorPersonal Satisfaction

Central Study Contacts

Héloïse BAILLET, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03