Patients With Moderate Depression,NCT01284803
Feasibility and Acceptability of an Educational Intervention to Improve the Management of Depression in Primary Care.
A study testing an educational intervention in people with Patients With Moderate Depression, and First or Second Episode, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care. Objective is to assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Moderate Depression,, First or Second Episode
- What is being tested?
- an educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jun 2014
- 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
- age between 18-65y
- moderate depression (CIM 10)
- first or second episode
- able to read and understand French language
Who cannot join
- psychotic symptoms
- severe depression
- bipolar disorder
- suicide risk
- substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of an Educational Intervention to Improve the Management of Depression in Primary Care
Qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care.
Objective is to assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care.
Read the detailed description
To assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care.
And perspectives are to elaborate an educational intervention to care depression in primary care
- Being tested
- an educational intervention
- Keywords
- patients, moderate depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an educational interventionBehavioural
To elaborate an educational program for the management of depression in primary care
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Not described Receives: Behavioral: an educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative study
It is a qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Moderate Depression,Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Lancon, Professor, Principal investigator, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284803
- Sponsor's protocol ID
- 2010-A00648-31
- Other IDs
- 2010/05
- Status last verified
- Apr 2015
- First submitted
- 26 Jan 2011
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Educational Intervention to Improve the Management of Depression in Primary Care
- ClinicalTrials.gov ID
- NCT01284803
- Acronym / sponsor ID
- 2010-A00648-31
- Keywords
- patients, moderate depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Jan 2011 (estimated)
- 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.
Qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care.
Objective is to assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care.
Detailed description
To assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care To elaborate an educational program for the management of depression in primary care.
And perspectives are to elaborate an educational intervention to care depression in primary care
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Behavioral: an educational intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18-65y
- moderate depression (CIM 10)
- first or second episode
- able to read and understand French language
Key exclusion criteria (5 listed)
- psychotic symptoms
- severe depression
- bipolar disorder
- suicide risk
- substance abuse
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 |
|---|---|---|
| an educational interventionTo elaborate an educational program for the management of depression in primary care | Behavioural | experimental arm |
Primary outcome
Qualitative study
Time frame: 12 months
It is a qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care.
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 21 Apr 2015.
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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.
Christophe Lancon, Professor principal investigator
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an educational intervention in people with Patients With Moderate Depression, and First or Second Episode, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 5 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 21 Apr 2015. 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 France. 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?
Qualitative study (time frame: 12 months). 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 21 Apr 2015.