- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01795755
YATEP - The Impact of Horse Assisted Therapy (HAT) on Treatment Outcomes (HAT)
The Impact of Horse Assisted Therapy (HAT) on Treatment Outcomes
The objective of the study is to assess the impact of horse assisted therapy (HAT) on:
- Addiction treatment outcomes (its effectiveness as an alternative therapy)
- Addiction treatment dropout & addiction relapse (its efficacy in preventing dropout).
Hypothesis: HAT will correlate with:
- beneficial treatment outcomes of depression, anxiety, aggression
- with improved self esteem & motivation
- lower treatment dropout & addiction relapse.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Inclusion of horses in therapeutic settings is a scientific issue with significant social and health implications in Norway. Challenges include increasing provision of horse assisted therapy of variable quality to vulnerable population groups with little substantiating evidence of associated benefit(s) due to lack of research, design issues, mainstream clinicians'/scientists' scepticism of "alternative therapy" and associated difficulties in attracting top researchers and funding. Extensive review of literature found a growing volume of studies but as indicated in the most recent systematic review, there are few studies with adequate research design.
Oslo University Hospital's Dept of Addiction Treatment - Youth (AUA) presents a unique research/evaluation potential to study HAT. It will treat approximately 100 patients per year aged 16 to 26 years with a primary diagnosis of addiction. Horse assisted therapy (using AUA's residential herd) is an integral part of the addiction therapeutic program. Furthermore, AUA's strong emphasis on research and its Youth Addiction Treatment Evaluation Project (YATEP) data base will provide an evidence base needed for sound study in an emerging area of science and psychotherapy.
Patient drop out from addiction therapy is high, often exceeding 50% (Stark 1992). Many AUA patients claim that they remain in treatment because of the horses.
The study is a randomised controlled trial of in-patients undergoing treatment. The Participant Group has treatment as usual plus HAT; the Control Group treatment as usual.
Participant and control groups are drawn from AUA patients (aged 16 to 26 years of age with a primary diagnosis of addiction International Classification of Diseases (ICD F10-F19), admitted between 2013 and 2014 to AUA's in-patient unit and who have consented to participate in research.
HAT is a structured program of 12 X 90 minute therapeutic sessions with horses, including horse care, ground and mounted work, conducted by two clinically qualified therapists who are also Level I Riding Instructors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0514
- Department of addiction treatment - youth
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary diagnosis of addictionInternational Classification of Diseases ICD F10-F19, admitted in 2011-2014 for treatment at AUA's in-patient unit
Exclusion Criteria:
- Ongoing psychoses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treat as usual + Horse assisted therapy ( HAT)
Treatment as usual means mentalization based inpatient treatment.
Horse assisted therapy(HAT) is a structured program of 12 X 90 minute sessions (horse care, ground and mounted work) conducted by two clinically qualified therapists.
|
1-3 month of inpatient treatment
A structured program of 12 X 90 minute HAT sessions (horse care, ground and mounted work) conducted by two clinically qualified therapists who are also Level I Riding Instructors.
|
Active Comparator: Treatment as usual
Treatment as usual means mentalization based inpatient treatment.
|
1-3 month of inpatient treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower treatment dropout
Time Frame: Within treatment period of upto 3 months
|
Reason for treatment exit, including drop out, is obtained from data recorded in the Department's YATEP data base.
|
Within treatment period of upto 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower emotional distress (composite measure)
Time Frame: Within the treatment period of upto 3 months
|
The measure tests whether depression, anxiety and depression improve with horse assisted therapy (as claimed in non-scientific/popular horse literature).
Measurements are taken using Hopkins Symptom Check List (HSCL-25) and Severity Indices of Personality Problems (SIPP-118) from data recorded in the Department's YATEP data base.
|
Within the treatment period of upto 3 months
|
Improved self-esteem
Time Frame: Winthin the treatment period of upto 3 months
|
The measure tests whether self-esteem improves with horse assisted therapy (as claimed in non-scientific/popular horse literature).
Improvement will be measured using the Rosenberg Self Esteem Scale from data recorded in the Department's YATEP data base.
|
Winthin the treatment period of upto 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Espen KA Arnevik, PhD, Oslo University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAT-11-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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