Clinical trial NCT06449690: Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression
Official title: Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Dog-assisted therapy
Lead sponsor: Fondation Bon Sauveur De La Manche
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks.
timeFrame: Baseline and week 6
Secondary outcomes:
measure: Evolution of the 17-item Hamilton scale score between 0 and 3 weeks.
timeFrame: Baseline and week 3
measure: Evolution of the quality of life scale score (WHOQOL-BREF) at 3 and 6 weeks, compared to the initial score at W0.
timeFrame: Baseline and weeks 3 and 6
measure: Evaluation of the number of adverse events and serious adverse events related to the therapy under study.
timeFrame: From baseline up to 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fondation Bon Sauveur De La Manche
name: Jérémy MADIGAND, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bousman CA, Arandjelovic K, Mancuso SG, Eyre HA, Dunlop BW. Pharmacogenetic tests and depressive symptom remission: a meta-analysis of randomized controlled trials. Pharmacogenomics. 2019 Jan;20(1):37-47. doi: 10.2217/pgs-2018-0142. Epub 2018 Dec 6.
citation: Lundqvist M, Carlsson P, Sjodahl R, Theodorsson E, Levin LA. Patient benefit of dog-assisted interventions in health care: a systematic review. BMC Complement Altern Med. 2017 Jul 10;17(1):358. doi: 10.1186/s12906-017-1844-7.
citation: Richerson JT, Wagner TH. Service Dogs for Veterans With PTSD. Psychiatr Serv. 2023 Jun 1;74(6):668-669. doi: 10.1176/appi.ps.20230164. No abstract available.
citation: Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.