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Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.

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ClinicalTrials.gov Identifier: NCT05115266
Recruitment Status : Not yet recruiting
First Posted : November 10, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Miguel Monfort Montolio, Cardenal Herrera University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diagnosis, Dual (Psychiatry) Behavioral: Animal-assisted therapy (AAT Behavioral: Usual treatment Not Applicable

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 borderline personality disorder and substance abuse disorder.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
Estimated Study Start Date : April 30, 2022
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group (EG)
Receive animal-assisted therapy and usual treatment (ATT)
 Behavioral: Animal-assisted therapy (AAT
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 Name: ATT
Active Comparator: Control group
Receive usual treatment
 Behavioral: Usual treatment
receive usual treatment (group activities)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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).

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Miguel Monfort Montolio, Miguel Monfort Montolio, member of the TXP research group at Cardenal Herrera University, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT05115266    
Other Study ID Numbers: AAT BPD&A
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miguel Monfort Montolio, Cardenal Herrera University:
Animal-assisted therapy
Borderline personality disorder
substance abuse
Dual pathology
Residential treatment
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders