- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05103865
Animal-Assisted Therapy in the Residential Treatment of Schizophrenia and Addictions
October 30, 2021 updated by: Miguel Monfort Montolio
Animal-assisted therapy (AAT) is a complementary intervention of therapy that has shown positive results in the treatment of various pathologies.
This study assesses the viability of the implementation and the efectiveness of an AAT program in patients diagnosed with substance abuse disorder and associated mental disorders (dual pathology).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Animal assisted therapy (AAT) is a complementary intervention to therapy that presents positive results in the treatment of different pathologies.
The study assesses the implementation and effectiveness of a TAA program in patients diagnosed with substance use disorder and schizophrenia spectrum disorder.
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meeting DSM-5 criteria for substance abuse disorder and the presence of schizophrenia
- Voluntary participant in the study and having signed the informed consent
Exclusion Criteria:
- Patients whose functioning could be altered by factors not specifically related to addictive pathology or mental disorder (severe cognitive impairment, intellectual deficiency or language barrier)
- Animal-specific phobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Control group
|
|
|
EXPERIMENTAL: Experimental group (EG)
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Life Skills Profile questionnaire (LSP)
Time Frame: Change from Life Skills at 3-6-9 months (12 minutes)
|
This questionnaire evaluates aspects of functioning that affect daily activities and the adaptation of people with mental illnesses in the community.
It contains 39 items that are grouped into self-care, social-interpersonal behaviour, communication-social contact, non-personal social behaviour and autonomous life
|
Change from Life Skills at 3-6-9 months (12 minutes)
|
|
Barrat impulsiveness scale (BIS-11)
Time Frame: Change from impulsiveness at 3-6-9 months (12 minutes)
|
This instrument is composed of 30 items distributed into three sub-scales: nonplanning, motor and attentional.
The total impulsiveness score was also obtained.
|
Change from impulsiveness at 3-6-9 months (12 minutes)
|
|
Calgary Depresión Scale for Schizophrenia (CDSS)
Time Frame: Change from Depresión at 3-6-9 months (12 minutes)
|
El cuestionario es un intrumento estructurado, adminisitrado por un clínico de forma heteroaplicada para población adulta, con un tiempo aproximado de administración de entre 10 y 30 minutos, y aborada el área terapéutica relativa a la sintomatología de los trastornos depresivos.
|
Change from Depresión at 3-6-9 months (12 minutes)
|
|
Rosenberg Self-Esteem Scale
Time Frame: Change from self.-esteem at 3-6-9 months (12 minutes)
|
The questionnaire consists of 10 statements of the feelings that the person has about himself.
Five of the statements are addressed positively (items 1, 2, 4, 6 and 7) and 5 negatively (items 3, 5, 8, 9 and 10).
|
Change from self.-esteem at 3-6-9 months (12 minutes)
|
|
Positive and negative symptom scale (PANSS)
Time Frame: Change from Positive and negative symptom at 3-6-9 months (12 minutes)
|
It is a semi-structured and hetero-applied questionnaire for the adult population.
The application time is between 30-60 minutes and evaluates the positive and negative symptoms of schizophrenia and other psychotic disorders.
|
Change from Positive and negative symptom at 3-6-9 months (12 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 3, 2015
Primary Completion (ACTUAL)
May 20, 2019
Study Completion (ACTUAL)
September 10, 2019
Study Registration Dates
First Submitted
October 20, 2021
First Submitted That Met QC Criteria
October 30, 2021
First Posted (ACTUAL)
November 2, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2021
Last Update Submitted That Met QC Criteria
October 30, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAT S&A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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