AddictionHATNCT01795755
YATEP - The Impact of Horse Assisted Therapy (HAT) on Treatment Outcomes
A study testing Mentalization based inpatient treatment. and Horse assisted Therapy (HAT) in people with Addiction, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 to 26 years
- Conditions the study is for
- Addiction
- What is being tested?
- Mentalization based inpatient treatment. and Horse assisted Therapy (HAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary diagnosis of addictionInternational Classification of Diseases ICD F10-F19, admitted in 2011-2014 for treatment at AUA's in-patient unit
Who cannot join
- Ongoing psychoses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Addiction
- Being tested
- Mentalization based inpatient treatment., Horse assisted Therapy (HAT)
- Keywords
- Horse Assisted Therapy (HAT), Equine Assisted Psychotherapy (EAP), clinical trial, Randomised Controlled Trial (RCT), psychotherapy
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization based inpatient treatment.Behavioural
1-3 month of inpatient treatment
Horse assisted Therapy (HAT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treat as usual + Horse assisted therapy ( HAT) | Experimental | 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. Receives: Behavioral: Mentalization based inpatient treatment.; Behavioral: Horse assisted Therapy (HAT) |
| Treatment as usual | Active comparator | Treatment as usual means mentalization based inpatient treatment. Receives: Behavioral: Mentalization based inpatient treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower treatment dropout
Reason for treatment exit, including drop out, is obtained from data recorded in the Department's YATEP data base.
Measured: Within treatment period of upto 3 months
Secondary outcomes (2)
Lower emotional distress (composite measure)
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.
Measured: Within the treatment period of upto 3 months
Improved self-esteem
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.
Measured: Winthin the treatment period of upto 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish-Norwegian Foundation for Equine Research, The Research Council of Norway
- Responsible party
- Principal investigator, Espen Walderhaug, Oslo University Hospital
- Investigators
- Espen KA Arnevik, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795755
- Sponsor's protocol ID
- HAT-11-1
- Acronym
- HAT
- Status last verified
- Oct 2020
- First submitted
- 6 Jul 2012
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gatti F, Walderhaug E, Kern-Godal A, Lysell J, Arnevik EA. Complementary horse-assisted therapy for substance use disorders: a randomized controlled trial. Addict Sci Clin Pract. 2020 Feb 4;15(1):7. doi: 10.1186/s13722-020-0183-z.
PubMed 32019584
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Horse Assisted Therapy (HAT) on Treatment Outcomes
- ClinicalTrials.gov ID
- NCT01795755
- Acronym / sponsor ID
- HAT / HAT-11-1
- Conditions
- Addiction
- Keywords
- Horse Assisted Therapy (HAT), Equine Assisted Psychotherapy (EAP), clinical trial, Randomised Controlled Trial (RCT), psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Swedish-Norwegian Foundation for Equine Research, The Research Council of Norway
- Study start
- Jan 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treat as usual + Horse assisted therapy ( HAT) | Experimental | Behavioral: Mentalization based inpatient treatment., Behavioral: 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. |
| Treatment as usual | Active comparator | Behavioral: Mentalization based inpatient treatment.Treatment as usual means mentalization based inpatient treatment. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Primary diagnosis of addictionInternational Classification of Diseases ICD F10-F19, admitted in 2011-2014 for treatment at AUA's in-patient unit
Key exclusion criteria (1 listed)
- Ongoing psychoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization based inpatient treatment.1-3 month of inpatient treatment | Behavioural | Treat as usual + Horse assisted therapy ( HAT), Treatment as usual |
| Horse assisted Therapy (HAT)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. | Behavioural | Treat as usual + Horse assisted therapy ( HAT) |
Primary outcome
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.
2 secondary outcomes
Lower emotional distress (composite measure)
Time frame: Within the treatment period of upto 3 months
Improved self-esteem
Time frame: Winthin the treatment period of upto 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 32019584Gatti F, Walderhaug E, Kern-Godal A, Lysell J, Arnevik EA. Complementary horse-assisted therapy for substance use disorders: a randomized controlled trial. Addict Sci Clin Pract. 2020 Feb 4;15(1):7. doi: 10.1186/s13722-020-0183-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Espen KA Arnevik, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalization based inpatient treatment. and Horse assisted Therapy (HAT) in people with Addiction, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower treatment dropout (time frame: Within treatment period of upto 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.