Substance Abuse DisorderNCT06652269
The Impact of Equine-Assisted Psychotherapy on Depression, Anxiety, and Stress in Patients with Substance Use Disorder in a Psychiatric Hospital
An observational study of Substance Abuse Disorder and Anxiety, run by Czech University of Life Sciences Prague at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Abuse Disorder, Anxiety, Depression Secondary to Other Disease
- What is being tested?
- Psychopharmacology intervention
- How many people
- 68 participants
- Where
- 1 siteCzechia
- Study dates
- 23 Mar 2022to 15 Dec 2023
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of psychiatric hospital with substance use disorder
Who may be able to join
- Patients of psychiatric hospital of Kosmonosy with substance use disorder
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Psychopharmacology intervention
- Keywords
- Equine asssited psychotherapy, substance use disorder, psychotherapy
- Medical subject headings
- Substance-Related Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychopharmacology interventionOther
Psychotherapy with horses
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Group with equine-assisted psychotherapy Receives: Other: Psychopharmacology intervention | |
| Control | Group with psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI)
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).
Measured: through study completion, an average of 18 months
Depression Anxiety and Stress Scale 21 (DASS-21)
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).
Measured: through study completion, an average of 18 months
Perceived Stress Scale (PSS)
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).
Measured: through study completion, an average of 18 months
Beck Anxiety Inventory (BAI)
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.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start23 Mar 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Czech University of Life Sciences Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doc. Ing. Kristýna Machová, Ph.D., Advanced Bionics
- Investigators
- Kristýna Machová, associate professor, Principal investigator, Czech university of life sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652269
- Sponsor's protocol ID
- 8870-VIII/2013
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data are available on Mendeley database (10.17632/bng79xc6pc.1).
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Equine-Assisted Psychotherapy on Depression, Anxiety, and Stress in Patients with Substance Use Disorder in a Psychiatric Hospital
- ClinicalTrials.gov ID
- NCT06652269
- Acronym / sponsor ID
- 8870-VIII/2013
- Keywords
- Equine asssited psychotherapy, substance use disorder, psychotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Czech University of Life Sciences PragueUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Psychopharmacology interventionGroup with equine-assisted psychotherapy |
| Control | – | –Group with psychotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of psychiatric hospital with substance use disorder
Key inclusion criteria (1 listed)
- Patients of psychiatric hospital of Kosmonosy with substance use disorder
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychopharmacology interventionPsychotherapy with horses | Other | Experimental |
Primary outcome
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).
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).
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: Yes. All data are available on Mendeley database (10.17632/bng79xc6pc.1).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristýna Machová, associate professor principal investigator
Czech university of life sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse Disorder and Anxiety, run by Czech University of Life Sciences Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) (time frame: through study completion, an average of 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.