NCT05115266

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 10, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

October 30, 2021

Last Update Submit

October 30, 2021

Conditions

Keywords

Animal-assisted therapyBorderline personality disordersubstance abuseDual pathologyResidential treatment

Outcome Measures

Primary Outcomes (5)

  • 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

    Change from Life Skills at 3-6-9 months (12 minutes)

  • 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

    Change from impulsiveness at 3-6-9 months (12 minutes)

  • 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.

    Change from Depresión at 3-6-9 months (12 minutes)

  • 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).

    Change from self-esteem at 3-6-9 months (12 minutes)

  • 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

    Change from Positive and negative symptom at 3-6-9 months (12 minutes)

Study Arms (2)

Experimental group (EG)

EXPERIMENTAL

Receive animal-assisted therapy and usual treatment (ATT)

Behavioral: Animal-assisted therapy (AAT

Control group

ACTIVE COMPARATOR

Receive usual treatment

Behavioral: Usual treatment

Interventions

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 ...

Also known as: ATT
Experimental group (EG)
Usual treatmentBEHAVIORAL

receive usual treatment (group activities)

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DiseaseBorderline Personality DisorderSubstance-Related Disorders

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPersonality DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Miguel Monfort Montolio, member of the TXP research group at Cardenal Herrera University

Study Record Dates

First Submitted

October 30, 2021

First Posted

November 10, 2021

Study Start

April 30, 2022

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

November 10, 2021

Record last verified: 2021-10