Back to resultsEfficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
Primary Purpose
Diagnosis, Dual (Psychiatry)
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Animal-assisted therapy (AAT
Usual treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diagnosis, Dual (Psychiatry) focused on measuring Animal-assisted therapy, Borderline personality disorder, substance abuse, Dual pathology, Residential treatment
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group (EG)
Control group
Arm Description
Receive animal-assisted therapy and usual treatment (ATT)
Receive usual treatment
Outcomes
Primary Outcome Measures
The Life Skills Profile questionnaire (LSP)
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
Barrat impulsiveness scale (BIS-11)
This instrument is composed of 30 items distributed into three sub-scales: nonplanning, motor and attentional. The total impulsiveness score was also obtained
Calgary Depresión Scale for Schizophrenia (CDSS)
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.
Rosenberg Self-Esteem Scale
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).
Positive and negative symptom scale (PANSS)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05115266
First Posted
October 30, 2021
Last Updated
October 30, 2021
Sponsor
Miguel Monfort Montolio
1. Study Identification
Unique Protocol Identification Number
NCT05115266
Brief Title
Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
Official Title
Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2022 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Miguel Monfort Montolio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnosis, Dual (Psychiatry)
Keywords
Animal-assisted therapy, Borderline personality disorder, substance abuse, Dual pathology, Residential treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group (EG)
Arm Type
Experimental
Arm Description
Receive animal-assisted therapy and usual treatment (ATT)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Receive usual treatment
Intervention Type
Behavioral
Intervention Name(s)
Animal-assisted therapy (AAT
Other Intervention Name(s)
ATT
Intervention Description
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 ...
Intervention Type
Behavioral
Intervention Name(s)
Usual treatment
Intervention Description
receive usual treatment (group activities)
Primary Outcome Measure Information:
Title
The Life Skills Profile questionnaire (LSP)
Description
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
Time Frame
Change from Life Skills at 3-6-9 months (12 minutes)
Title
Barrat impulsiveness scale (BIS-11)
Description
This instrument is composed of 30 items distributed into three sub-scales: nonplanning, motor and attentional. The total impulsiveness score was also obtained
Time Frame
Change from impulsiveness at 3-6-9 months (12 minutes)
Title
Calgary Depresión Scale for Schizophrenia (CDSS)
Description
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.
Time Frame
Change from Depresión at 3-6-9 months (12 minutes)
Title
Rosenberg Self-Esteem Scale
Description
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).
Time Frame
Change from self-esteem at 3-6-9 months (12 minutes)
Title
Positive and negative symptom scale (PANSS)
Description
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
Time Frame
Change from Positive and negative symptom at 3-6-9 months (12 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
We'll reach out to this number within 24 hrs