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

Depression Clinical Trial

— DATID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449690
• Other study ID #: FBSM-001
• Secondary ID: N° ID-RCB : 2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: June 2024
• Source: Fondation Bon Sauveur De La Manche
• Contact: Ludovic PRIME, MSc
• Phone: +33 2 33 77 77 77
• Email: ludovic.prime[@]fbs50.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• Occupational activities
Occupational activities consist of origami, relaxation, sports or board games sessions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Bon Sauveur De La Manche

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks.	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	Evolution of the 17-item Hamilton scale score between 0 and 3 weeks.	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
Secondary	Evolution of the quality of life scale score (WHOQOL-BREF) at 3 and 6 weeks, compared to the initial score at W0.	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
Secondary	Evaluation of the number of adverse events and serious adverse events related to the therapy under study.	The number of AEs will be used to assess the safety of the therapy.	From baseline up to 6 weeks