- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06652269
The Impact of Equine-Assisted Psychotherapy on Depression, Anxiety, and Stress in Patients with Substance Use Disorder in a Psychiatric Hospital
October 18, 2024 updated by: doc. Ing. Kristýna Machová, Ph.D., Czech University of Life Sciences Prague
This study aims to assess whether an EAP program affects anxiety, depression, and stress, which are often associated with substance use disorder.
The management of these conditions has a major impact on the control of the addiction.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study aimed to evaluate the effect of an EAP program on 32 respondents in the experimental group and 36 in the control group.
These respondents were patients in a psychiatric hospital who were taking part in an addiction treatment program.
The EAP program was conducted weekly over four weeks, with each session lasting three hours.
The treatment effects were assessed using the STAI-Y modules 1 and 2, BAI, PSS, and DASS-21 questionnaires.
The groups were compared before and after the four-week observation period.
Study Type
Observational
Enrollment (Actual)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kosmonosy, Czech Republic, 29306
- Psychiatrická nemocnice Kosmonosy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients of psychiatric hospital with substance use disorder
Description
Inclusion Criteria:
Patients of psychiatric hospital of Kosmonosy with substance use disorder
Exclusion Criteria:
Exclusion criteria were possible cognitive deficit or reluctance to work with animals. Participants who did not complete all required materials or left the treatment program before completion were excluded from the study (N = 9).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Experimental
Group with equine-assisted psychotherapy
|
Psychotherapy with horses
|
|
Control
Group with psychotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Inventory (STAI)
Time Frame: through study completion, an average of 18 months
|
The State-Trait Anxiety Inventory (STAI) is an instrument evaluating the current level of anxiety and personality traits.
It was translated into the czech in 2019 by Figalová (2019).
Scoring is done using a template, and the range of final scores is 20-80 for each subscale.
The higher the score, the higher the level of anxiety or fear.
The scores can be divided into three categories-no or low perceived anxiety/anxiousness, moderate anxiety/anxiousness, and high anxiety/anxiousness (Müllner et.
al, 1980; Figalová, 2019).
|
through study completion, an average of 18 months
|
|
Depression Anxiety and Stress Scale 21 (DASS-21)
Time Frame: through study completion, an average of 18 months
|
The DASS-21 scale has 21 items.
Respondents rate their experiences in the past week on a four-point Likert scale (0 = not at all; 1 = sometimes; 2 = often; 3 = almost always).
The questionnaire has three subscales: depression, anxiety, and stress.
The depression subscale focuses on the patient's low mood, anhedonia, hopelessness, self-deprecation, devaluation of life, and decreased motivation.
The anxiety subscale focuses on physiological arousal, subjective feelings of tension, situational anxiety, and fear.
The stress subscale measures the inability to relax, tension, impatience, and irritability.
For all three subscales, scores are categorized as normal, mild, moderate, severe, and extremely severe (Lovibond & Lovibond, 1995).
|
through study completion, an average of 18 months
|
|
Perceived Stress Scale (PSS)
Time Frame: through study completion, an average of 18 months
|
The Perceived Stress Scale (PSS) is a self-report scale to measure non-specific perceived stress (Cohen et.
al, 1983).
It is a short scale that is easy to administer, can be administered individually or in groups, is easy to score, and has satisfactory psychometric properties despite its small size.
It is the most commonly used psychological instrument to measure perceived stress (Cohen & Janicki-Deverts, 2009).
The scale consists of 10 items.
Within the PSS, scores can be divided into three categories: low stress, moderate stress, and high perceived stress (Buršíková et al., 2018).
|
through study completion, an average of 18 months
|
|
Beck Anxiety Inventory (BAI)
Time Frame: through study completion, an average of 18 months
|
The Beck Anxiety Inventory (BAI; [Beck et al., 1988]) is a self-report instrument useful for assessing general anxiety in patients with anxiety disorders or depression.
The BAI allows for the assessment of actual levels of anxiety.
It assesses the expression of both somatic and psychological symptoms of anxiety.
The questionnaire has excellent internal consistency (Cronbach's alpha = 0.92) and satisfactory test-retest performance (r = 0.75) at one week.
The categories can be divided into minimal anxiety, mild anxiety, moderate anxiety, and severe anxiety.
|
through study completion, an average of 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kristýna Machová, associate professor, Czech university of life sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2022
Primary Completion (Actual)
December 15, 2023
Study Completion (Actual)
December 15, 2023
Study Registration Dates
First Submitted
October 10, 2024
First Submitted That Met QC Criteria
October 18, 2024
First Posted (Actual)
October 22, 2024
Study Record Updates
Last Update Posted (Actual)
October 22, 2024
Last Update Submitted That Met QC Criteria
October 18, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8870-VIII/2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data are available on Mendeley database (10.17632/bng79xc6pc.1).
IPD Sharing Time Frame
Unending- All data are available on Mendeley database https://data.mendeley.com/datasets/bng79xc6pc/1
IPD Sharing Access Criteria
All data are available on Mendeley database https://data.mendeley.com/datasets/bng79xc6pc/1
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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