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

NCT06449690 | Not Yet Recruiting

• 2 other identifiers: FBSM-001N° ID-RCB : 2024-A00645-42
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Keywords

Depression; Dog-assisted therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Dog-assisted therapy

EXPERIMENTAL

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.

Procedure: Dog-assisted therapy

Occupational activities

ACTIVE COMPARATOR

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.

Procedure: Occupational activities

Interventions

Dog-assisted therapy PROCEDURE

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.

Dog-assisted therapy

Occupational activities PROCEDURE

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

Occupational activities

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Bon Sauveur De La Manche: lead

Related 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.

  PMID: 30520364 BACKGROUND

• 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.

  PMID: 28693538 BACKGROUND

• 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.

  PMID: 37259586 BACKGROUND

• 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.

  PMID: 17074942 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jérémy MADIGAND, MD

  Fondation Bon Sauveur De La Manche

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludovic PRIME, MSc

CONTACT

+33 2 33 77 77 77; ludovic.prime@fbs50.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 10, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share