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Clinical Trials/NCT06449690
NCT06449690
Not yet recruiting
Not Applicable

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

Fondation Bon Sauveur De La Manche0 sites58 target enrollmentSeptember 1, 2024
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Fondation Bon Sauveur De La Manche
Enrollment
58
Primary Endpoint
Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks.
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
December 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fondation Bon Sauveur De La Manche
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Evolution of the 17-item Hamilton scale score between 0 and 3 weeks.(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.(Baseline and weeks 3 and 6)
  • Evaluation of the number of adverse events and serious adverse events related to the therapy under study.(From baseline up to 6 weeks)

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