Eating Disorders in AdolescenceNCT04869423
Animal-Assisted Therapy in Adolescents With Eating Disorders
A study testing Dog-Assisted Therapy in people with Eating Disorders in Adolescence and Eating Disorders, run by Daniel Collado-Mateo at 1 site in Spain.
Trial summary
This study aims to improve eating disorders symptomatology, mental, psychosocial and physical health, quality of life, strength and body composition of adolescents with eating disorders by the development of a dog-assisted therapy program. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eating Disorders in Adolescence, Eating Disorders, Anorexia Nervosa/Bulimia
- What is being tested?
- Dog-Assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2021to 30 Nov 2021
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents in the Psychiatry and Psychology Service of the Niño Jesús University Hospital
- Patients diagnosed with eating disorders
- Adolescents with the willingness to participate and availability to assist
- Having read and signed the written informed consent.
Who cannot join
- Patients with dog-allergy or dog phobia
- Adolescents with a history of impulsive animal aggression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dog-assisted Therapy in Adolescents With Eating Disorders: a Controlled Trial.
This study aims to improve eating disorders symptomatology, mental, psychosocial and physical health, quality of life, strength and body composition of adolescents with eating disorders by the development of a dog-assisted therapy program.
The current research will involve thirty-two patients distributed equally in a control and an experimental group. The intervention group will participate once a week in a dog-assisted therapy of seven weeks. Moreover, all the included patients will participate in an assessment session before and after the intervention to compare the effects of the dog-assisted therapy within and between groups in anxiety, depression, character, behavior, eating disorder evolution, health-related quality of life, treatment satisfaction, strength and body composition.
Based on previous studies on different populations, it is expected that, compared to the control group, the experimental group may experience a potential reduction in anxiety, depression and symptoms, while improving quality of life, strength, body composition and behavior.
Read the detailed description
Animal-Assisted Therapies (AAT) have proved to increase self-esteem, social capacity and impulse control while reducing anxiety and depression. Thus, AAT could be an innovative and effective therapy to improve the mental, social and physical health of adolescents with eating disorders.
Based on previous studies on different populations, it is expected that, compared to the control group, the experimental group may experience a potential reduction in anxiety, depression and symptoms, while improving quality of life, strength, body composition and behavior.
Thirty-two adolescents, younger than 18 years and diagnosed with eating disorders from the University Hospital Niño Jesus will participate in this study. The informed consent must be signed to be included in the study.
The intervention will consist of 7 weeks conducted once a week (50 minutes each session). It will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to say goodbye to the dogs.
- Being tested
- Dog-Assisted Therapy
- Keywords
- Dog-assisted intervention, Eating Disorder Symptom, Depression, Anxiety, Adolescent behavior and character, Health-related quality of life, Strength, Body composition, Treatment satisfaction
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia, Depression, Anxiety Disorders, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog-Assisted TherapyBehavioural
Also called animal-assisted therapy, animal-assisted intervention
During seven weeks patients will assist one time per week (1 hour). The therapy will be conducted by an expert psychologist. The intervention will consist of 7 weeks conducted once a week (50 minutes each session). It will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to say goodbye to the dogs.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in this group will simply continue with their daily living and therapies. Assessments will be conducted before and after the 7wk program but patients in this group will not take part in it |
| Experimental group | Experimental | Participants in this group will take part in 7 dog-assisted therapy sessions (1 per week). This therapy will be added to their usual daily living and therapies. Assessments will be conducted before and after the 7-week program. Receives: Behavioral: Dog-Assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Eating disorder symptoms
Measured by the EDI-2 questionnaire to evaluate the evolution of anorexia nervosa and bulimia nervosa normal symptoms. The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). Respondents rate each item from 5 (usually), to 0 (never). Higher scores mean more severe symptoms.
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Health-related quality of life
Measured by the Kidscreen-10, which consists of 10 items scored on a 5-point Likert scale. Scores range between 10 and 50, and a higher score means better health-related quality of life.
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary outcomes (7)
Changes in Anxiety
Measured by the STAI-C questionnaire. It includes two different scales, one to asses state anxiety (20 items) and the other one to evaluate trait anxiety (20 items) in Spanish adolescents. Each item is rated from 1 to 3 thus, scores in each sub-scales can range from a minimum of 20 to a maximum score of 60. Higher scores mean higher anxiety.
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Depression
Measured by the Children Depression Inventory with the included 27 items, each one with 3 options, from 0 (absence of symptoms) to 2 (severe symptoms). The total score ranges from 0-54. Higher scores mean higher depression.
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Adolescent character
Measured by the Temperament and Character Inventory-Revised. It consists of 240 items and 5 options for each one. It measures 4 temperaments, Novelty Seeking (NS), Harm Avoidance (HA), Reward Dependence (RD), and Persistence (PS), and three characters, Self-directedness (SD), Cooperativeness (CO), and Self-transcendence (ST). Each item is scored from 1 to 5 with higher scores meaning higher levels in each dimension.
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Behavior
Measured by the Child Behavior Checklist inside the Achenbach System of Empirically Based Assessment to assess adolescents' psychopathology. It consists of 113 items and the parents must complete it to evaluate emotional and behavioural problems in children and adolescents. It is scored from 0="not true" to 2="true". Raw scores range from 0 to 226. Higher scores mean a worse outcome.
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Strength
Measured by a handgrip dynamometer (Takei) to evaluate the maximum strength applied with the hand.
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Body mass
Assessed using a weighing device
Measured: At baseline and inmediately after the intervention (within 7 days after the last session)
Treatment satisfaction
Measured by the treatment satisfaction scale (CRES-4) by Feixas i Viaplana et al., 2012, which consists of 3 dimensions. The score in each one ranges from 0 to 100 and the global score is the sum of the dimensions (from 0 to 300). Higher scores mean higher satisfaction.
Measured: Inmediately after the intervention (within 7 days after the last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start30 Apr 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating Disorders in AdolescenceStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: one control and one experimental group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Collado-Mateo
- Sponsor type
- University, hospital or other
- Collaborators
- Purina España (Reg. Trademark of Nestle S.A.)
- Responsible party
- Sponsor-investigator, Daniel Collado-Mateo, Universidad Rey Juan Carlos
- Investigators
- Daniel Collado-Mateo, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869423
- Sponsor's protocol ID
- AAT_Eat_Disorders
- Status last verified
- Sep 2021
- First submitted
- 28 Apr 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez Nunez B, Fernandez Sanchez J, Lavin Perez AM, Lobato Rincon LL, Fonseca Garcia M, Gonzalez Garcia I, Graell Berna M, Collado Mateo D. Effects of Dog-assisted Therapy in Anxiety Symptoms of Female Adolescents With Eating Disorders: A Controlled Trial. Actas Esp Psiquiatr. 2025 Dec;53(6):1265-1273. doi: 10.62641/aep.v53i6.1919.
PubMed 41437761
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dog-assisted Therapy in Adolescents With Eating Disorders: a Controlled Trial.
- ClinicalTrials.gov ID
- NCT04869423
- Acronym / sponsor ID
- AAT_Eat_Disorders
- Keywords
- Dog-assisted intervention, Eating Disorder Symptom, Depression, Anxiety, Adolescent behavior and character, Health-related quality of life, Strength, Body composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Daniel Collado-MateoUniversity, hospital or other
- Collaborators
- Purina España (Reg. Trademark of Nestle S.A.)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 3 May 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.
This study aims to improve eating disorders symptomatology, mental, psychosocial and physical health, quality of life, strength and body composition of adolescents with eating disorders by the development of a dog-assisted therapy program.
The current research will involve thirty-two patients distributed equally in a control and an experimental group. The intervention group will participate once a week in a dog-assisted therapy of seven weeks. Moreover, all the included patients will participate in an assessment session before and after the intervention to compare the effects of the dog-assisted therapy within and between groups in anxiety, depression, character, behavior, eating disorder evolution, health-related quality of life, treatment satisfaction, strength and body composition.
Based on previous studies on different populations, it is expected that, compared to the control group, the experimental group may experience a potential reduction in anxiety, depression and symptoms, while improving quality of life, strength, body composition and behavior.
Detailed description
Animal-Assisted Therapies (AAT) have proved to increase self-esteem, social capacity and impulse control while reducing anxiety and depression. Thus, AAT could be an innovative and effective therapy to improve the mental, social and physical health of adolescents with eating disorders.
Based on previous studies on different populations, it is expected that, compared to the control group, the experimental group may experience a potential reduction in anxiety, depression and symptoms, while improving quality of life, strength, body composition and behavior.
Thirty-two adolescents, younger than 18 years and diagnosed with eating disorders from the University Hospital Niño Jesus will participate in this study. The informed consent must be signed to be included in the study.
The intervention will consist of 7 weeks conducted once a week (50 minutes each session). It will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to say goodbye to the dogs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two groups: one control and one experimental group
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in this group will simply continue with their daily living and therapies. Assessments will be conducted before and after the 7wk program but patients in this group will not take part in it |
| Experimental group | Experimental | Behavioral: Dog-Assisted TherapyParticipants in this group will take part in 7 dog-assisted therapy sessions (1 per week). This therapy will be added to their usual daily living and therapies. Assessments will be conducted before and after the 7-week program. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescents in the Psychiatry and Psychology Service of the Niño Jesús University Hospital
- Patients diagnosed with eating disorders
- Adolescents with the willingness to participate and availability to assist
- Having read and signed the written informed consent.
Key exclusion criteria (2 listed)
- Patients with dog-allergy or dog phobia
- Adolescents with a history of impulsive animal aggression
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 |
|---|---|---|
| Dog-Assisted TherapyAlso: animal-assisted therapy, animal-assisted interventionDuring seven weeks patients will assist one time per week (1 hour). The therapy will be conducted by an expert psychologist. The intervention will consist of 7 weeks conducted once a week (50 minutes each session). It will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to say goodbye to the dogs. | Behavioural | Experimental group |
Primary outcome
Changes in Eating disorder symptoms
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Measured by the EDI-2 questionnaire to evaluate the evolution of anorexia nervosa and bulimia nervosa normal symptoms. The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). Respondents rate each item from 5 (usually), to 0 (never). Higher scores mean more severe symptoms.
Changes in Health-related quality of life
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Measured by the Kidscreen-10, which consists of 10 items scored on a 5-point Likert scale. Scores range between 10 and 50, and a higher score means better health-related quality of life.
7 secondary outcomes
Changes in Anxiety
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Depression
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Adolescent character
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Behavior
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Strength
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Changes in Body mass
Time frame: At baseline and inmediately after the intervention (within 7 days after the last session)
Treatment satisfaction
Time frame: Inmediately after the intervention (within 7 days after the last session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 41437761Martinez Nunez B, Fernandez Sanchez J, Lavin Perez AM, Lobato Rincon LL, Fonseca Garcia M, Gonzalez Garcia I, Graell Berna M, Collado Mateo D. Effects of Dog-assisted Therapy in Anxiety Symptoms of Female Adolescents With Eating Disorders: A Controlled Trial. Actas Esp Psiquiatr. 2025 Dec;53(6):1265-1273. doi: 10.62641/aep.v53i6.1919.
- Individual participant dataSharing planned: No
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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.
Daniel Collado-Mateo, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog-Assisted Therapy in people with Eating Disorders in Adolescence and Eating Disorders, run by Daniel Collado-Mateo at 1 site in Spain.
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 4 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in Eating disorder symptoms (time frame: At baseline and inmediately after the intervention (within 7 days after the last session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869423, which also lists 1 linked publication.
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 28 Sep 2021.