- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115266
Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
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 effectiveness of an AAT program in patients diagnosed with borderline personality disorder and substance abuse disorder.
Our hypotheses are that participation in the TAA program will reduce negative symptoms, improve the quality of life of people with dual pathology, whose mental illness is schizophrenia, and increase adherence to treatment for people with dual pathology, whose mental disorder it's schizophrenia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meeting DSM-5 criteria for substance abuse disorder and the presence of borderline personality disorder.
- 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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group (EG)
Receive animal-assisted therapy and usual treatment (ATT)
|
The activity program consists of 10 sessions with a duration of about 60 minutes.
During the 10 sessions the animal is presented, in this case a dog.
They caress it, dress it, educate it ...
Other Names:
|
|
Active Comparator: Control group
Receive usual treatment
|
receive usual treatment (group activities)
|
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 behavior 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)
|
The questionnaire is a structured instrument, administered by a clinician in a hetero-applied way for the adult population, with an approximate administration time of between 10 and 30 minutes, and covers the therapeutic area related to the symptoms of depressive disorders.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- AAT BPD&A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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