DepressionNCT06915207
Adult Depression and Integrative Medical Care
A study testing Counselling, behavioural, nutrition in people with Depression, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The goal of this quasi-experimental study is to learn if integrative medical care works to treat depression in adults and compare it to usual medical care. The main question it aims to answer is to find out whether integrative medical care is equal or better to usual medical care in treating depressed adults over one… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Counselling, behavioural, nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2017to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- experiencing depressive symptoms as defined by a Centre for Epidemiologic Studies-Depression (CES-D) scale score of 16 or higher as categorized by Lewinsohn et al.
- willing to commit to five study visits over one year.
Who cannot join
- substance abuse
- pregnancy
- non-depression neurological problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrative Medical Care For Adult Depression: A One Year Pilot Project
The goal of this quasi-experimental study is to learn if integrative medical care works to treat depression in adults and compare it to usual medical care. The main question it aims to answer is to find out whether integrative medical care is equal or better to usual medical care in treating depressed adults over one year.
Participants attended five data collection visits which occurred at baseline, 3, 6, 9 and 12 months. At each visit, they completed questionnaires and had a small blood sample drawn. They were also asked to keep a diary of their symptoms and what they did between visits. They brought a calendar summary with a saliva sample at visits 2 to 5.
- Conditions
- Depression
- Being tested
- Counselling, behavioural, nutrition
- Keywords
- adults, Depression, Integrative medical care, quasi-experimental design
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling, behavioural, nutritionDietary supplement
integrative medical care delivered by one physician and referral to other health professionals as appropriate
| Study group | Role | What they receive |
|---|---|---|
| Usual care for depression | No intervention | Medication for depression |
| Intervention | Active comparator | Integrative medical care Receives: Dietary Supplement: Counselling, behavioural, nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
as measured by the Beck Depression Inventory (BDI) test. It has a continuous range of whole number scores from 0-63 that correspond to four categories of depression: minimal (0-13), mild (14-19), moderate (20-28) and severe (29-63)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Dec 2017
- Primary completion31 May 2020
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal over 1 year
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Leis, University of Saskatchewan
- Investigators
- Anne Leis, PhD, Principal investigator, University of SaskatchewanShirley Maltman, MD, Study chair, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915207
- Sponsor's protocol ID
- USaskatchewan-CH&E
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is a small pilot study
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Medical Care For Adult Depression: A One Year Pilot Project
- ClinicalTrials.gov ID
- NCT06915207
- Acronym / sponsor ID
- USaskatchewan-CH&E
- Conditions
- Depression
- Keywords
- adults, Depression, Integrative medical care, quasi-experimental design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Apr 2025 (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.
The goal of this quasi-experimental study is to learn if integrative medical care works to treat depression in adults and compare it to usual medical care. The main question it aims to answer is to find out whether integrative medical care is equal or better to usual medical care in treating depressed adults over one year.
Participants attended five data collection visits which occurred at baseline, 3, 6, 9 and 12 months. At each visit, they completed questionnaires and had a small blood sample drawn. They were also asked to keep a diary of their symptoms and what they did between visits. They brought a calendar summary with a saliva sample at visits 2 to 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Longitudinal over 1 year
| Arm | Type | Receives |
|---|---|---|
| Usual care for depression | No intervention | –Medication for depression |
| Intervention | Active comparator | Dietary Supplement: Counselling, behavioural, nutritionIntegrative medical care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- experiencing depressive symptoms as defined by a Centre for Epidemiologic Studies-Depression (CES-D) scale score of 16 or higher as categorized by Lewinsohn et al.
- willing to commit to five study visits over one year.
Key exclusion criteria (3 listed)
- substance abuse
- pregnancy
- non-depression neurological problems.
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 |
|---|---|---|
| Counselling, behavioural, nutritionintegrative medical care delivered by one physician and referral to other health professionals as appropriate | Dietary supplement | Intervention |
Primary outcome
Change in depression
Time frame: one year
as measured by the Beck Depression Inventory (BDI) test. It has a continuous range of whole number scores from 0-63 that correspond to four categories of depression: minimal (0-13), mild (14-19), moderate (20-28) and severe (29-63)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Yes. This is a small pilot study
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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. This study is not recruiting at the moment.
Anne Leis, PhD principal investigator
University of Saskatchewan
Shirley Maltman, MD study chair
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling, behavioural, nutrition in people with Depression, run by University of Saskatchewan at 1 site in Canada.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.