Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression (DATID)

June 5, 2024 updated by: Fondation Bon Sauveur De La Manche

Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression: a Randomized Controlled Trial

This study is a randomized controlled trial (comparing "occupational activities" versus "dog-assisted therapy" arms) investigating the effectiveness of animal-assisted therapy with dogs in small groups of participants with depression. Patients in the "dog-assisted therapy" arm will participate in two group sessions (groups of 3 to 7 participants) of canine-assisted therapy, supervised by a healthcare professional certified in animal-assisted therapy alongside a psychiatric caregiver, for 30 minutes each week over 6 weeks. Patients in the "occupational activities" arm will participate in two group sessions (groups of 3 to 7 participants) of occupational activities, supervised by a healthcare professional experienced in group occupational activities alongside a psychiatric caregiver, for 30 minutes each week over 6 weeks.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged 18 to 65
  • Patient affiliated with a social security scheme
  • Patient hospitalized under voluntary psychiatric care
  • Diagnosis of depression according to DSM-5-TR criteria
  • QIDS-C16 score ≥11 at screening
  • QIDS-SR16 score ≥11 at screening and inclusion

Exclusion Criteria:

  • Severe comorbid psychiatric disorder
  • Imminent risk of suicidal behavior
  • Unstable comorbid somatic condition
  • Vulnerable patients (under guardianship, curatorship, or judicial protection)
  • Known fear of dogs
  • Known allergy to dog fur

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dog-assisted therapy
Patients in the "dog-assisted therapy" arm will participate in two group sessions (groups of 3 to 7 participants) of canine-assisted therapy, supervised by a healthcare professional certified in animal-assisted therapy alongside a psychiatric caregiver, for 30 minutes each week over 6 weeks.
Procedure: Dog-assisted therapy
Dog-assisted therapy consists of the search for positive interactions resulting from the intentional human-animal relationship in the educational, therapeutic or social fields, practices as they are conducted in educational and medico-social institutions for example.
Active Comparator: Occupational activities
Patients in the "occupational activities" arm will participate in two group sessions (groups of 3 to 7 participants) of occupational activities, supervised by a healthcare professional experienced in group occupational activities alongside a psychiatric caregiver, for 30 minutes each week over 6 weeks.
Procedure: Occupational activities
Occupational activities consist of origami, relaxation, sports or board games sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks.
Time Frame: Baseline and week 6
The 17-item Hamilton Depression Rating Scale (HDRS) is a validated scale for depression assessment, its score is rated between 0 and 52 and a higher score means a more depressed state
Baseline and week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the 17-item Hamilton scale score between 0 and 3 weeks.
Time Frame: Baseline and week 3
The 17-item Hamilton Depression Rating Scale (HDRS) is a validated scale for depression assessment, its score is rated between 0 and 52 and a higher score means a more depressed state
Baseline and week 3
Evolution of the quality of life scale score (WHOQOL-BREF) at 3 and 6 weeks, compared to the initial score at W0.
Time Frame: Baseline and weeks 3 and 6
The World Health Organization Quality Of Life (WHOQOL) WHOQOL-BREF scale is a validated scale for the measurement of quality of life, its score is rated between 0 and 100 and a higher score means better quality of life
Baseline and weeks 3 and 6
Evaluation of the number of adverse events and serious adverse events related to the therapy under study.
Time Frame: From baseline up to 6 weeks
The number of AEs will be used to assess the safety of the therapy.
From baseline up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Bon Sauveur De La Manche

Investigators

  • Principal Investigator: Jérémy MADIGAND, MD, Fondation Bon Sauveur De La Manche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBSM-001
  • N° ID-RCB : 2024-A00645-42 (Other Identifier: ANSM (France))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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