Unipolar DepressionPhase 2NCT00319540
RCT of Psychoeducational Program of Depression
A Phase 2 study of Unipolar Depression, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
The purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 155 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2001to Mar 2002
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exclusion Criteria:Psychosis, other psychiatric disorders, subclinical depression, suicidal ideation, learning disabilities
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Psychoeducational Group Program for Unipolar Depression in Adults in Norway
The purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression
Read the detailed description
Unipolar depression is a common disorder which may be treated by drugs or psychological intervention. Many patients prefer psychological treatment, but there is a lack of professional skills and methods for effectively dealing with this in the primary health services,where most of the depressed patients are seen.For this reason it is of great importance to develop and test psychological methods which may be applied in the primary health services, as well as in the specialized psychiatric services.In the present study a psychoeducational group method is tested, with trained psychiatric nurses as the most common group leaders.
Comparison: People with unipolar depression receiving "treatment as usual"
- Conditions
- Unipolar Depression
- Being tested
- Control with depression course (CWD)
- Keywords
- Depression, psychoeducation, RCT, primary health services
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control with depression course (CWD)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMar 2001
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unipolar 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Investigators
- Odd Steffen Dalgard, M.D., Ph.D., Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319540
- Sponsor's protocol ID
- 2906
- Status last verified
- Jan 2001
- First submitted
- 28 Apr 2006
- Last updated
- 6 Apr 2022
- Results posted
- No
Publications
Ducasse D, Courtet P, Seneque M, Genty C, Picot MC, Schwan R, Olie E. Effectiveness of the first French psychoeducational program on unipolar depression: study protocol for a randomized controlled trial. BMC Psychiatry. 2015 Nov 17;15:294. doi: 10.1186/s12888-015-0667-7.
PubMed 26578205
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Psychoeducational Group Program for Unipolar Depression in Adults in Norway
- ClinicalTrials.gov ID
- NCT00319540
- Acronym / sponsor ID
- 2906
- Conditions
- Unipolar Depression
- Keywords
- Depression, psychoeducation, RCT, primary health services
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- Mar 2001
- Study completion
- Mar 2002
- First posted
- 27 Apr 2006 (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.
The purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression
Detailed description
Unipolar depression is a common disorder which may be treated by drugs or psychological intervention. Many patients prefer psychological treatment, but there is a lack of professional skills and methods for effectively dealing with this in the primary health services,where most of the depressed patients are seen.For this reason it is of great importance to develop and test psychological methods which may be applied in the primary health services, as well as in the specialized psychiatric services.In the present study a psychoeducational group method is tested, with trained psychiatric nurses as the most common group leaders.
Comparison: People with unipolar depression receiving "treatment as usual"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria:Psychosis, other psychiatric disorders, subclinical depression, suicidal ideation, learning disabilities
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Control with depression course (CWD) | Behavioural | – |
Primary outcome
BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
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 6 Apr 2022.
- Derived from this study: PubMed 26578205Ducasse D, Courtet P, Seneque M, Genty C, Picot MC, Schwan R, Olie E. Effectiveness of the first French psychoeducational program on unipolar depression: study protocol for a randomized controlled trial. BMC Psychiatry. 2015 Nov 17;15:294. doi: 10.1186/s12888-015-0667-7.
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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.
Odd Steffen Dalgard, M.D., Ph.D. principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Unipolar Depression, run by Norwegian Institute of Public Health at 1 site in Norway.
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 0 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 6 Apr 2022. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression. 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 NCT00319540, which also lists 1 linked publication.
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 6 Apr 2022.