DepressionDATIDNCT06449690
Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression
A study testing Dog-assisted therapy and Occupational activities in people with Depression, run by Fondation Bon Sauveur De La Manche.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Dog-assisted therapy and Occupational activities
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression: a Randomized Controlled Trial
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
- Being tested
- Dog-assisted therapy, Occupational activities
- Keywords
- Depression, Dog-assisted therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog-assisted therapyProcedure or surgery
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 activitiesProcedure or surgery
Occupational activities consist of origami, relaxation, sports or board games sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Occupational activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and week 6
Secondary outcomes (3)
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
Measured: 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.
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
Measured: Baseline and weeks 3 and 6
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.
Measured: From baseline up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Bon Sauveur De La Manche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémy MADIGAND, MD, Principal investigator, Fondation Bon Sauveur De La Manche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449690
- Sponsor's protocol ID
- FBSM-001
- Other IDs
- N° ID-RCB : 2024-A00645-42
- Acronym
- DATID
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30520364Lundqvist 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.
PubMed 28693538Richerson 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.
PubMed 37259586Rush 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.
PubMed 17074942
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06449690
- Acronym / sponsor ID
- DATID / FBSM-001
- Conditions
- Depression
- Keywords
- Depression, Dog-assisted therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Fondation Bon Sauveur De La MancheUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dog-assisted therapy | Experimental | Procedure: Dog-assisted therapyPatients 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. |
| Occupational activities | Active comparator | Procedure: Occupational activitiesPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dog-assisted therapyDog-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. | Procedure or surgery | Dog-assisted therapy |
| Occupational activitiesOccupational activities consist of origami, relaxation, sports or board games sessions. | Procedure or surgery | Occupational activities |
Primary outcome
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
3 secondary outcomes
Evolution of the 17-item Hamilton scale score between 0 and 3 weeks.
Time frame: 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.
Time frame: Baseline and weeks 3 and 6
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Background: PubMed 30520364Bousman 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.
- Background: PubMed 28693538Lundqvist 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.
- Background: PubMed 37259586Richerson 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.
- Background: PubMed 17074942Rush 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jérémy MADIGAND, MD principal investigator
Fondation Bon Sauveur De La Manche
Questions about this trial
What is this clinical trial studying?
A study testing Dog-assisted therapy and Occupational activities in people with Depression, run by Fondation Bon Sauveur De La Manche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludovic PRIME, MSc (+33 2 33 77 77 77, ludovic.prime@fbs50.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks. (time frame: Baseline and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449690, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.