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Animal-Assisted Therapy in Adolescents With Eating Disorders

Primary Purpose

Eating Disorders in Adolescence, Eating Disorders, Anorexia Nervosa/Bulimia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dog-Assisted Therapy
Sponsored by
Daniel Collado-Mateo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eating Disorders in Adolescence focused on measuring Dog-assisted intervention, Eating Disorder Symptom, Depression, Anxiety, Adolescent behavior and character, Health-related quality of life, Strength, Body composition, Treatment satisfaction

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Niño Jesús University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Changes in Strength
Measured by a handgrip dynamometer (Takei) to evaluate the maximum strength applied with the hand.
Changes in Body mass
Assessed using a weighing device
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.

Full Information

First Posted
April 28, 2021
Last Updated
September 25, 2021
Sponsor
Daniel Collado-Mateo
Collaborators
Purina España (Reg. Trademark of Nestle S.A.)
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1. Study Identification

Unique Protocol Identification Number
NCT04869423
Brief Title
Animal-Assisted Therapy in Adolescents With Eating Disorders
Official Title
Effects of Dog-assisted Therapy in Adolescents With Eating Disorders: a Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Collado-Mateo
Collaborators
Purina España (Reg. Trademark of Nestle S.A.)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders in Adolescence, Eating Disorders, Anorexia Nervosa/Bulimia
Keywords
Dog-assisted intervention, Eating Disorder Symptom, Depression, Anxiety, Adolescent behavior and character, Health-related quality of life, Strength, Body composition, Treatment satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: one control and one experimental group
Masking
Investigator
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dog-Assisted Therapy
Other Intervention Name(s)
animal-assisted therapy, animal-assisted intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Eating disorder symptoms
Description
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.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in Health-related quality of life
Description
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.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary Outcome Measure Information:
Title
Changes in Anxiety
Description
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.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in Depression
Description
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.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in Adolescent character
Description
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.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in Behavior
Description
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.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in Strength
Description
Measured by a handgrip dynamometer (Takei) to evaluate the maximum strength applied with the hand.
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Changes in Body mass
Description
Assessed using a weighing device
Time Frame
At baseline and inmediately after the intervention (within 7 days after the last session)
Title
Treatment satisfaction
Description
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.
Time Frame
Inmediately after the intervention (within 7 days after the last session)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Collado-Mateo, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Niño Jesús University Hospital
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Animal-Assisted Therapy in Adolescents With Eating Disorders

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