NCT04869423

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

April 28, 2021

Last Update Submit

September 25, 2021

Conditions

Keywords

Dog-assisted interventionEating Disorder SymptomDepressionAnxietyAdolescent behavior and characterHealth-related quality of lifeStrengthBody compositionTreatment satisfaction

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At baseline and inmediately after the intervention (within 7 days after the last session)

Secondary Outcomes (7)

  • Changes in Anxiety

    At baseline and inmediately after the intervention (within 7 days after the last session)

  • Changes in Depression

    At baseline and inmediately after the intervention (within 7 days after the last session)

  • Changes in Adolescent character

    At baseline and inmediately after the intervention (within 7 days after the last session)

  • Changes in Behavior

    At baseline and inmediately after the intervention (within 7 days after the last session)

  • Changes in Strength

    At baseline and inmediately after the intervention (within 7 days after the last session)

  • +2 more secondary outcomes

Study Arms (2)

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.

Behavioral: Dog-Assisted Therapy

Interventions

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.

Also known as: animal-assisted therapy, animal-assisted intervention
Experimental group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with dog-allergy or dog phobia
  • Adolescents with a history of impulsive animal aggression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niño Jesús University Hospital

Madrid, 28009, Spain

Location

Related Publications (1)

  • Nunez BM, Sanchez JF, Perez AML, Rincon LL, Garcia MF, Garcia IG, Berna MG, Mateo DC. 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.

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimiaDepressionAnxiety DisordersAdolescent Behavior

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHyperphagiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Daniel Collado-Mateo, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups: one control and one experimental group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 3, 2021

Study Start

April 30, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations