NCT05632185

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

August 22, 2023

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

November 20, 2022

Last Update Submit

August 19, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • emotion regulation questionnaire

    assess how respondents tend to regulate their emotions positively through cognitive reappraisal, or negatively through expressive suppression.

    Six months

  • 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)

    Six months

  • 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.

    Six months

Study Arms (2)

Control group

NO INTERVENTION

standard regular treatment modalities

Equine assisted intervention

ACTIVE COMPARATOR

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

Behavioral: Equine-assisted Therapy

Interventions

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

Equine assisted intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult diagnosed with substance use disorder, hospitalized for at least one month in the study hospital, and physically able to deal with horses

You may not qualify if:

  • other physical or psychological ailments preventing them from active participation in the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behman hospital, Helwan, Cairo, Egypt

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nagwa Souilm, Doctor

    Bani-Suef University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagwa Souilm, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: one group will receive Equine assisted intervention, and a control group to receive the regular care used in the setting
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2022

First Posted

November 30, 2022

Study Start

November 10, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

August 22, 2023

Record last verified: 2022-11

Locations