NCT05103865

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 efectiveness of an AAT program in patients diagnosed with substance abuse disorder and associated mental disorders (dual pathology).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

November 3, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

3.5 years

First QC Date

October 20, 2021

Last Update Submit

October 30, 2021

Conditions

Keywords

Animal-assisted therapyeveryday life skillsschizophreniaresidential treatmentdual pathology

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 behaviour 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)

    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

    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
Behavioral: Animal-assisted therapy (AAT)

Control group

ACTIVE COMPARATOR
Other: usual treatment

Interventions

Also known as: ATT
Experimental group (EG)
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 schizophrenia
  • 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

DiseaseSchizophrenia

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental 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
Sponsor-investigator

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 2, 2021

Study Start

November 3, 2015

Primary Completion

May 20, 2019

Study Completion

September 10, 2019

Last Updated

November 2, 2021

Record last verified: 2021-10