Diagnosis, Dual (Psychiatry)NCT05115266
Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
A study testing Animal-assisted therapy (AAT and Usual treatment in people with Diagnosis, Dual (Psychiatry), run by Miguel Monfort Montolio.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnosis, Dual (Psychiatry)
- What is being tested?
- Animal-assisted therapy (AAT and Usual treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Diagnosis, Dual (Psychiatry)
- Being tested
- Animal-assisted therapy (AAT, Usual treatment
- Keywords
- Animal-assisted therapy, Borderline personality disorder, substance abuse, Dual pathology, Residential treatment
- Medical subject headings
- Disease, Borderline Personality Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted therapy (AATBehavioural
Also called 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 ...
Usual treatmentBehavioural
receive usual treatment (group activities)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (EG) | Experimental | Receive animal-assisted therapy and usual treatment (ATT) Receives: Behavioral: Animal-assisted therapy (AAT |
| Control group | Active comparator | Receive usual treatment Receives: Behavioral: Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: Change from Positive and negative symptom at 3-6-9 months (12 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start30 Apr 2022 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis, Dual (Psychiatry)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miguel Monfort Montolio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miguel Monfort Montolio, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115266
- Sponsor's protocol ID
- AAT BPD&A
- Status last verified
- Oct 2021
- First submitted
- 30 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
- ClinicalTrials.gov ID
- NCT05115266
- Acronym / sponsor ID
- AAT BPD&A
- Conditions
- Diagnosis, Dual (Psychiatry)
- Keywords
- Animal-assisted therapy, Borderline personality disorder, substance abuse, Dual pathology, Residential treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Miguel Monfort MontolioUniversity, hospital or other
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (EG) | Experimental | Behavioral: Animal-assisted therapy (AATReceive animal-assisted therapy and usual treatment (ATT) |
| Control group | Active comparator | Behavioral: Usual treatmentReceive usual treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted therapy (AATAlso: ATTThe 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 ... | Behavioural | Experimental group (EG) |
| Usual treatmentreceive usual treatment (group activities) | Behavioural | Control group |
Primary outcome
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
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
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.
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).
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted therapy (AAT and Usual treatment in people with Diagnosis, Dual (Psychiatry), run by Miguel Monfort Montolio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Life Skills Profile questionnaire (LSP) (time frame: Change from Life Skills at 3-6-9 months (12 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.