NCT06652269

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 23, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

October 10, 2024

Last Update Submit

October 18, 2024

Conditions

Keywords

Equine asssited psychotherapysubstance use disorderpsychotherapy

Outcome Measures

Primary Outcomes (4)

  • 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).

    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).

    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).

    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.

    through study completion, an average of 18 months

Study Arms (2)

Experimental

Group with equine-assisted psychotherapy

Other: Psychopharmacology intervention

Control

Group with psychotherapy

Interventions

Psychotherapy with horses

Experimental

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of psychiatric hospital with substance use disorder

You may qualify if:

  • Patients of psychiatric hospital of Kosmonosy with substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatrická nemocnice Kosmonosy

Kosmonosy, 29306, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Psychometric scales

MeSH Terms

Conditions

Substance-Related DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kristýna Machová, associate professor

    Czech university of life sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 22, 2024

Study Start

March 23, 2022

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

All data are available on Mendeley database (10.17632/bng79xc6pc.1).

Shared Documents
ANALYTIC CODE
Time Frame
Unending- All data are available on Mendeley database https://data.mendeley.com/datasets/bng79xc6pc/1
Access Criteria
All data are available on Mendeley database https://data.mendeley.com/datasets/bng79xc6pc/1

Locations