Depression
Conditions
Keywords
Depression, Dog-assisted therapy
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.
Interventions
PROCEDUREDog-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.
PROCEDUREOccupational activities
Occupational activities consist of origami, relaxation, sports or board games sessions.
Sponsors
Fondation Bon Sauveur De La Manche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactLudovic PRIME, MSc
Outcome results
None listed