- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07495839
The Impact of Equine-Assisted Therapy on Mental Health and Addictive Behaviors in Patients Receiving Addiction Treatment (EQUI-ADDICT)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Héloïse BAILLET, Dr
- Phone Number: +33(0)232293047
- Email: h.baillet@hlrs-lamusse.net
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Patients in the experimental group will receive 22 sessions of equine-assisted therapy over a 24-week period
|
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.
|
|
No Intervention: Control Group
Patients in the control group will not receive equine-assisted therapy sessions but will only undergo various follow-up assessments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The score on the Craving Experience Questionnaire
Time Frame: 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 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The total score on the Beck Depression Inventory
Time Frame: 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 Beck Depression Inventory is one of the most widely used screening tools for measuring the severity of depression in adults and adolescents over the age of 13.
It consists of 21 items related to depressive symptoms (e.g., hopelessness and irritability), cognitions (e.g., guilt or feelings of being punished), and physical symptoms (e.g., fatigue, weight loss, and loss of interest in sex).
Each item is rated on a severity scale ranging from 0 to 3, with a total score ranging from 0 to 63.
The higher the score, the more severe the depression.
|
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
Time Frame: at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.
|
As with depression, the Beck Anxiety Inventory consists of 21 items corresponding to anxiety symptoms identified in large clinical samples (e.g., panic disorder and generalized anxiety disorder).
Each item is rated on a severity scale ranging from 0 (not at all) to 3 (very much), with a total score ranging from 0 to 63.
The higher the score, the more severe the anxiety.
|
at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.
|
|
Scores on the WHOQOL-BREF quality of life questionnaire
Time Frame: at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.
|
With 26 items, the WHOQOL-BREF is a shortened version of the WHOQOL-100, an instrument designed to measure subjective quality of life.
This is defined as an individual's perception of their own life situation within the context of their culture and value system, as well as in relation to personal goals, expectations, evaluation criteria, and interests.
The WHOQOL-BREF was developed as a generic quality of life questionnaire and is therefore not limited to specific areas of application.
The questionnaire is completed by the respondent.
The WHOQOL-BREF covers the four domains of physical health, psychological well-being, social relationships, and environment.
Items are rated on a five-point scale (from "not at all" to "somewhat no," "about," "most of the time," to "completely").
The scales exhibit very high internal consistency.
The WHOQOL has received widespread international support and is available in multiple languages.
It is validated and reliable.
|
at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.
|
|
Scores on the WHO-5 Well-Being Questionnaire
Time Frame: 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 WHO-5 is a measure of mental well-being consisting of five statements referring to the past two weeks.
Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being.
The instrument has been translated into more than 30 languages.
|
at the start of the program (week 1), then 5 weeks, 13 weeks, 25 weeks, and 37 weeks after the start of the program.
|
|
Physical health scores
Time Frame: 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 6-minute walk test (6MWT), Timed Up and Go Test (TUG) and the numerical Pain Scale.
|
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
Time Frame: Each week, up to 37 weeks
|
The number of relapses recorded in the logbook, which the patient fills out themselves throughout the study (weekly), thereby assessing their addictive behaviors
|
Each week, up to 37 weeks
|
|
The number, intensity, and duration of self-reported cravings
Time Frame: Each week, up to 37 weeks
|
The number, intensity, and duration of self-reported cravings, recorded in the logbook completed by the patient throughout the study
|
Each week, up to 37 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A02429-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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