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Equine-assisted Therapy Effectiveness in Improving Emotion Regulation of Patients Suffering From Substance Use Disorder

Primary Purpose

Substance Use Disorder (SUD)

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Equine-assisted Therapy
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorder (SUD)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult diagnosed with substance use disorder, hospitalized for at least one month in the study hospital, and physically able to deal with horses Exclusion Criteria: other physical or psychological ailments preventing them from active participation in the intervention

Sites / Locations

  • Behman hospital, Helwan, Cairo, EgyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Equine assisted intervention

Arm Description

standard regular treatment modalities

patients will receive weekly equine-assisted therapy sessions over a period of 8 weeks in addition to their standard regular therapy

Outcomes

Primary Outcome Measures

emotion regulation questionnaire
assess how respondents tend to regulate their emotions positively through cognitive reappraisal, or negatively through expressive suppression.
General Self-efficacy (GSE) scale
10 statements on a 4-point Likert type scale ranging from "not at all true" (scored 1) to "exactly true" (scored 4)
the self-esteem test
50 statements such as: "I often feel like I don't know what is expected of me," and "I am not vey aware of my feelings." The respondent is asked to check the statements he/she feels true for him/her.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2022
Last Updated
August 19, 2023
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05632185
Brief Title
Equine-assisted Therapy Effectiveness in Improving Emotion Regulation of Patients Suffering From Substance Use Disorder
Official Title
Equine-assisted Therapy Effectiveness in Improving Emotion Regulation, Self-efficacy, and Perceived Self-esteem of Patients Suffering From Substance Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Substance Use Disorder (SUD) is a term replacing the diagnoses of abuse and dependence adopted in DSM-4 and DSM-5 . It is an overwhelming public health problem throughout the world, with increasing trends throughout the last few decades. This study aims to assess the effectiveness of quine-assisted addiction therapy in improving emotion regulation, self-efficacy, and perceived self-esteem among patients suffering from substance use disorders. This open-label randomized controlled trial study will be conducted at Behman hospital, Helwan, Cairo, Egypt. It will include all patients suffering substance use disorder randomized into two equal groups: one group will receive Equine assisted intervention, and a control group to receive the regular care used in the setting. A self-administered questionnaire with tools for emotion regulation questionnaire, General Self-efficacy (GSE) scale, and Self- Esteem will be used to collect data.
Detailed Description
Research design: A randomized controlled trial design will be utilized in this study. Setting: The study will conduct Behman hospital, Helwan, Cairo, Egypt. It was founded in 1940 as the first private psychiatric hospital in Egypt. With a 210-bed capacity, the hospital is considered as one of the biggest medical centers in Helwan, Egypt. The hospital is the pioneer of equine psychotherapy in Egypt. Duration of the Study: The four phases of data collection are expected to take 6 months, from December 2022 to May 2023. Subjects: The study population will consist of all Patients suffering from substance use disorder receiving their care at Behman hospital, during the time of the study. The inclusion criteria will be being adult diagnosed with substance use disorder, hospitalized for at least one month in the study hospital, and physically able to deal with horses. Those patients suffering from any other physical or psychological ailments preventing them from active participation in the intervention will exclude. The remaining patients will equally randomized, using simple random numbers computer program, into an intervention group to receive the equine assisted therapy and a control group to receive the regular care used in the setting. Data collection tools: Data will be collected using a self-administered questionnaire with standardized tools for assessment of emotion regulation, General Self-Efficacy, and perceived self-esteem, in addition to a section for the demographic and disease characteristics developed by the researchers. This cover data about patient age, gender, current marital status, place of residence, educational level, current job status, income, as well as age at start and duration of substance of use etc. The first tool emotion regulation questionnaire developed by Gross and John (2003). It will be used to assess how respondents tend to regulate their emotions positively through cognitive reappraisal, or negatively through expressive suppression. It consists of ten statements: 6 for cognitive reappraisal (such as "When I want to feel more positive emotion, I change the way I'm thinking about the situation"), and 4 for expressive suppression (4 statements such as "When I am feeling negative emotions, I make sure not to express them"). The responses are on a 7-point Likert-type scale ranging from "strongly disagree" to "strongly agree." The scores of each dimension are summed giving a maximum total score of 42 for the appraisal dimension and 28 for the suppression dimension. A higher score indicates more appraisal or more suppression. Scoring is kept continuous according to tool instructions. The tool demonstrated high validity and reliability in previous studies (Mauss et al., 2005; Ochsner and Gross, 2005). The second tool will be the General Self-efficacy (GSE) scale developed by Schwarzer and Jerusalem (1995). It also has 10 statements on a 4-point Likert type scale ranging from "not at all true" (scored 1) to "exactly true" (scored 4). Examples of statements are: "It is easy for me to stick to my aims and accomplish my goals," and "I can solve most problems if I invest the necessary effort." A total score ranging from 10 to 40 is obtained simple summation of items' scores. A higher score denotes more GSE. The reliability of the tool as well as its concurrent and predictive validity were documented (Schwarzer and Jerusalem, 2010). The third tool will be the self-esteem test developed by Sorensen (2006). The tool has 50 statements such as: "I often feel like I don't know what is expected of me," and "I am not vey aware of my feelings." The respondent is asked to check the statements he/she feels true for him/her. The number of items checked is calculated, ranging from zero to 50. A higher number indicates lower self-esteem. The tool was validated and showed good reliability (Martín-Albo et al., 2007).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder (SUD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one group will receive Equine assisted intervention, and a control group to receive the regular care used in the setting
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
standard regular treatment modalities
Arm Title
Equine assisted intervention
Arm Type
Active Comparator
Arm Description
patients will receive weekly equine-assisted therapy sessions over a period of 8 weeks in addition to their standard regular therapy
Intervention Type
Behavioral
Intervention Name(s)
Equine-assisted Therapy
Intervention Description
An equine therapy session typically consists of specific tasks and challenges to overcome, with the aid and guidance of horses. There is no riding involved and no specific skills are necessary to take part in these sessions
Primary Outcome Measure Information:
Title
emotion regulation questionnaire
Description
assess how respondents tend to regulate their emotions positively through cognitive reappraisal, or negatively through expressive suppression.
Time Frame
Six months
Title
General Self-efficacy (GSE) scale
Description
10 statements on a 4-point Likert type scale ranging from "not at all true" (scored 1) to "exactly true" (scored 4)
Time Frame
Six months
Title
the self-esteem test
Description
50 statements such as: "I often feel like I don't know what is expected of me," and "I am not vey aware of my feelings." The respondent is asked to check the statements he/she feels true for him/her.
Time Frame
Six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult diagnosed with substance use disorder, hospitalized for at least one month in the study hospital, and physically able to deal with horses Exclusion Criteria: other physical or psychological ailments preventing them from active participation in the intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nagwa Souilm, Doctor
Email
nagwamohamed@rocketmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagwa Souilm, Doctor
Organizational Affiliation
Bani-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behman hospital, Helwan, Cairo, Egypt
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagwa Souilm, Doctor
Email
nagwamohamed@rocketmail.com

12. IPD Sharing Statement

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Equine-assisted Therapy Effectiveness in Improving Emotion Regulation of Patients Suffering From Substance Use Disorder

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