Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression
- Conditions
- Depression
- Registration Number
- NCT06449690
- Lead Sponsor
- Fondation Bon Sauveur De La Manche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks. 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 Outcome Measures
Name Time Method Evolution of the 17-item Hamilton scale score between 0 and 3 weeks. 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
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 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
Evaluation of the number of adverse events and serious adverse events related to the therapy under study. From baseline up to 6 weeks The number of AEs will be used to assess the safety of the therapy.