NCT04200612

Brief Summary

Equine-assisted interventions (EAI) are an emerging form of alternate psychotherapy that has been increasingly found to produce improvements in various treatment outcomes. However, the paucity of randomized-controlled trials (RCTs) in the EAI literature prevents any definitive conclusions to be made about the general effectiveness of EAI. This study tests whether one form of EAI, Equine-Assisted Psychotherapy (EAP), reduces aggression and alters risk factors associated with aggression in young adults, and whether emotion regulation mediates any effect of EAP on aggression. In a single-blind RCT, undergraduate students will be randomly assigned to either an intervention group, an active-control group, or a placebo-control group. Participants in the intervention group will undergo a 5-week EAP program consisting of structured, interactive activities with horses followed by a clinical processing component. Participants in the active control group will undergo a 5-week program that only involves interactions with horses without any clinical input (i.e. commonly coined as animal-assisted activities). Participants in the placebo-control group will undergo 5 weeks of 1-hour movie sessions related to horses. There will be three waves of data collection measuring key outcome variables - t1 before the 1st session, t2 after the 3rd session, and t3 after the final session. Participants will complete questionnaires assessing the key outcomes of aggression, emotional well-being and academic performance. Other risk factors of antisocial behaviour such as psychopathy, level of empathy, emotion regulation and executive functioning will also be measured. To the author's knowledge, the current study is the first in Singapore to investigate if EAP can lower aggression levels and alter psychological risk factors for aggression in healthy young adults. In turn, these results could help inform the utility and validity of EAP in the forensic populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

December 11, 2019

Last Update Submit

March 2, 2021

Conditions

Keywords

Equine-Assisted PsychotherapyEmotion RegulationAggressionOutcomesRandomized-Controlled Trials

Outcome Measures

Primary Outcomes (18)

  • Young Adult Behavioral Scale (YABS)

    Min. Value: 1 (never), Max. Value: 5 (always), higher scores indicate a higher likelihood in the domains of relational aggression, social aggression and interpersonal maturity.

    Immediately before the 1st intervention session

  • Young Adult Behavioral Scale (YABS)

    Min. Value: 1 (never), Max. Value: 5 (always), higher scores indicate a higher likelihood in the domains of relational aggression, social aggression and interpersonal maturity.

    Immediately after the 3rd intervention session

  • Young Adult Behavioral Scale (YABS)

    Min. Value: 1 (never), Max. Value: 5 (always), higher scores indicate a higher likelihood in the domains of relational aggression, social aggression and interpersonal maturity.

    Immediately after the 5th intervention session

  • Reactive-Proactive Aggression Questionnaire (RPQ)

    Min. Value: 0 (never), Max. Value: 2 (often), higher scores indicate higher general aggression levels

    Immediately before the 1st intervention session

  • Reactive-Proactive Aggression Questionnaire (RPQ)

    Min. Value: 0 (never), Max. Value: 2 (often), higher scores indicate higher general aggression levels

    Immediately after the 3rd intervention session

  • Reactive-Proactive Aggression Questionnaire (RPQ)

    Min. Value: 0 (never), Max. Value: 2 (often), higher scores indicate higher general aggression levels

    Immediately after the 5th intervention session

  • Depression Anxiety Stress Scale - 21 items (DASS-21)

    Min. Value: 0 (did not apply to me at all), Max. Value: 3 (applied to me very much, or most of the time), higher scores indicate poorer emotional well-being

    Immediately before the 1st intervention session

  • Depression Anxiety Stress Scale - 21 items (DASS-21)

    Min. Value: 0 (did not apply to me at all), Max. Value: 3 (applied to me very much, or most of the time), higher scores indicate poorer emotional well-being

    Immediately after the 3rd intervention session

  • Depression Anxiety Stress Scale - 21 items (DASS-21)

    Min. Value: 0 (did not apply to me at all), Max. Value: 3 (applied to me very much, or most of the time), higher scores indicate poorer emotional well-being

    Immediately after the 5th intervention session

  • Motivated strategies for Learning Questionnaire (MSLQ)

    Min. Value: 1 (not at all true of me), Max. Value: 7 (very true of me), higher scores indicate greater motivations to learn using the different strategies

    Immediately before the 1st intervention session

  • Motivated strategies for Learning Questionnaire (MSLQ)

    Min. Value: 1 (not at all true of me), Max. Value: 7 (very true of me), higher scores indicate greater motivations to learn using the different strategies

    Immediately after the 3rd intervention session

  • Motivated strategies for Learning Questionnaire (MSLQ)

    Min. Value: 1 (not at all true of me), Max. Value: 7 (very true of me), higher scores indicate greater motivations to learn using the different strategies

    Immediately after the 5th intervention session

  • Emotion Regulation Questionnaire (ERQ)

    Min. Value: 1 (strongly disagree), Max. Value: 7 (strongly agree), higher scores indicate greater likelihood of using the two types of emotion regulation strategies

    Immediately before the 1st intervention session

  • Emotion Regulation Questionnaire (ERQ)

    Min. Value: 1 (strongly disagree), Max. Value: 7 (strongly agree), higher scores indicate greater likelihood of using the two types of emotion regulation strategies

    Immediately after the 3rd intervention session

  • Emotion Regulation Questionnaire (ERQ)

    Min. Value: 1 (strongly disagree), Max. Value: 7 (strongly agree), higher scores indicate greater likelihood of using the two types of emotion regulation strategies

    Immediately after the 5th intervention session

  • Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

    Min. Value: 1 (almost never), Max. Value: 5 (almost always), higher scores indicate greater difficulties with emotion regulation

    Immediately before the 1st intervention session

  • Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

    Min. Value: 1 (almost never), Max. Value: 5 (almost always), higher scores indicate greater difficulties with emotion regulation

    Immediately after the 3rd intervention session

  • Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

    Min. Value: 1 (almost never), Max. Value: 5 (almost always), higher scores indicate greater difficulties with emotion regulation

    Immediately after the 5th intervention session

Secondary Outcomes (9)

  • Self-Report Psychotherapy - Short Form (SRP-SF)

    Immediately before the 1st intervention session

  • Self-Report Psychotherapy - Short Form (SRP-SF)

    Immediately after the 3rd intervention session

  • Self-Report Psychotherapy - Short Form (SRP-SF)

    Immediately after the 5th intervention session

  • Cognitive, Affective and Somatic Empathy Scales (CASES)

    Immediately before the 1st intervention session

  • Cognitive, Affective and Somatic Empathy Scales (CASES)

    Immediately after the 3rd intervention session

  • +4 more secondary outcomes

Study Arms (3)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will go through the 5-week EAP program consisting of the clinical processing following some activities found in EAP manuals.

Behavioral: Equine-Assisted PsychotherapyBehavioral: Equine-Assisted Activities

Active-control group

ACTIVE COMPARATOR

Participants in the active-control group will undergo a 5-week program that only involves interactions with horses without any clinical input (i.e. commonly coined as animal-assisted activities).

Behavioral: Equine-Assisted Activities

Placebo-control group

PLACEBO COMPARATOR

Participants in the placebo-control group will undergo a 5-week movie screening of 1 hour each session that is related to horses.

Other: Placebo-control group

Interventions

Equine-Assisted Psychotherapy (EAP) involves working on the psychological goals set between the client and the mental health professional. This is done through the experiential interactions between the clients and the horse. This experiential aspect is vital as it allows clients to process the emotions, thoughts and behaviors that were expressed during sessions with the horse.

Also known as: Equine-Facilitated Psychotherapy
Intervention Group

Simple interactions with the horses that does not necessarily involve any goals being set between the client and the personnel handling the session. These can involve activities such as grooming or petting of the horse.

Active-control groupIntervention Group

This group will only be watching movies related to horses and they are told that this is another form of EAP even though this is not the case. This type of intervention has not been known to provide any therapeutic effect relevant to the study and thus is used as the placebo-control.

Placebo-control group

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Do not have any medical allergies or discomfort from interaction with horses.

You may not qualify if:

  • Participants who self-report an existing diagnosis for a psychological disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition: DSM-V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therapeutic and Educational Riding in Singapore

Singapore, 286965, Singapore

Location

MeSH Terms

Conditions

AggressionAntisocial Personality DisorderEmotional Regulation

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorPersonality DisordersMental DisordersSelf-Control

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Olivia Choy, PhD

    Nanyang Technological University

    PRINCIPAL INVESTIGATOR
  • Lim SM Matthew, PhD, PsyD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are informed that they will be randomly assigned to either a EAP horse interaction group or a EAP horse movie group. They are told that this study is meant to investigate the outcomes of two different types of EAP. In actuality, there are 3 groups in total - one intervention and two control groups. Participants in the intervention and active-control group will be told that they are in the EAP horse interaction group whereas participants in the placebo-control group are told that they are in the EAP horse movie group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The design of the experiment will be a single-blind Randomized Controlled Trial. Participants are randomly assigned to either an intervention group, an active-control group or a placebo-control group. Participants in the intervention group will go through the 5-week EAP program consisting of the clinical processing following some activities found in EAP manuals. Participants in the active-control group will undergo a 5-week program that only involves interactions with horses without any clinical input (i.e. commonly coined as animal-assisted activities). Participants in the placebo-control group will undergo a 5-week movie screening of 1 hour each session that is related to horses in the lab.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 16, 2019

Study Start

January 20, 2020

Primary Completion

April 9, 2020

Study Completion

November 6, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

There is no plans for such sharing as of now.

Locations