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NCT Number: NCT06449690

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Occupational activities

Procedure

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

Primary outcomes

  1. Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks.

    Time frame: 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 outcomes

  1. Evolution of the 17-item Hamilton scale score between 0 and 3 weeks.

    Time frame: 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

  2. Evolution of the quality of life scale score (WHOQOL-BREF) at 3 and 6 weeks, compared to the initial score at W0.

    Time frame: 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

  3. Evaluation of the number of adverse events and serious adverse events related to the therapy under study.

    Time frame: From baseline up to 6 weeks

    The number of AEs will be used to assess the safety of the therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Ludovic PRIME, MSc

CONTACT

[email protected]

+33 2 33 77 77 77

Sponsors and collaborators

Lead sponsor

Fondation Bon Sauveur De La Manche

Other

Registry information

Official study title

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

Acronym: DATID

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2024
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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