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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Czech Republic
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental
Group with equine-assisted psychotherapy
Other: Psychopharmacology intervention
Psychotherapy with horses
Control
Group with psychotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Czech University of Life Sciences Prague

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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