Animal-Assisted Therapy in Adolescents With Eating Disorders

Eating Disorders Clinical Trial

Official title:

Effects of Dog-assisted Therapy in Adolescents With Eating Disorders: a Controlled Trial.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04869423
• Other study ID #: AAT_Eat_Disorders
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: September 2021
• Source: King Juan Carlos University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with dog-allergy or dog phobia

• Adolescents with a history of impulsive animal aggression

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anorexia Nervosa/Bulimia
• Bulimia
• Disease
• Eating Disorders
• Eating Disorders in Adolescence
• Feeding and Eating Disorders

Intervention

Behavioral:
• Dog-Assisted Therapy
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.

Locations

Country	Name	City	State
Spain	Niño Jesús University Hospital	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Collado-Mateo	Purina España (Reg. Trademark of Nestle S.A.)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary	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.	At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary	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.	At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary	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.	At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary	Changes in Strength	Measured by a handgrip dynamometer (Takei) to evaluate the maximum strength applied with the hand.	At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary	Changes in Body mass	Assessed using a weighing device	At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary	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.	Inmediately after the intervention (within 7 days after the last session)