Depression in Old AgeNCT04078282
The Use of Collaborative Care in General Practice for Elderly Patients With Depression
A study testing Intervention group in people with Depression in Old Age, run by University of Oslo at 1 site in Norway.
Trial summary
The first part of this study aims to identify the occurence of depression in the elderly. In the second part, older patients with depression will be invited to a collaborative care with his or her family physician and a psychiatrist specialized in psychiatry in the elderly in accordance with a study protocol. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression in Old Age
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 15 Sep 2019to 30 Dec 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- all patients visiting one of the collaborative family physicians during the enrollment period of four weeks
Who cannot join
- cognitive dysfunction
- speaking Norwegian language
Trial locations and contacts
1 site in 1 country.
About this study
The first part of this study aims to identify the occurence of depression in the elderly. In the second part, older patients with depression will be invited to a collaborative care with his or her family physician and a psychiatrist specialized in psychiatry in the elderly in accordance with a study protocol. The intervention includes two sessions where the patient will meet the psychiatrist together with the family physician, and between the two sessions the patient will have three treatment sessions with the family physician based on the evaluation by the psychiatrist. Following the last session with the psychiatrist the intervention ends with three more treatment sessions with the family physician.
Read the detailed description
The frequency of depression in the elderly is little known and experiences from family practice indicate that older people not always communicate their mental health issues or present physical complaints which may arise from a state of depression. In this study we aim to register the occurence of depression among all patients at the age of 65 or older who visit their family physician. During a period of four weeks, all patients meeting the eligibility criteria will be asked to answer a questionnaire about mental and physic health issues. Those who respond in a manner that gives reasons to believe there is a depression will be contacted by their family physician to meet for a consultation and examination. If this examination confirms the diagnosis the patient will either be treated as usual by their family physician (control group) or be invited to a collaborative care with the family physician in cooperation with a psychiatrist who is specialized in psychiatry in the elderly (intervention group). In the control group the patients will receive usual care at their family physician or be referred to a psychiatrist or a psychologist if appropriate. In the intervention group the patients will have a evaluation session with the family physician and the psychiatrist together. Following this session, the patient and the family physician will meet for three treatment consultations based on the evaluation and recommendations given by the psychiatrist. Then there will be one more joint session with the patient, the family physician and the psychiatrist and the whole treatment program ends with three more treatment consultations at the family physician. - The aim of this intervention is to examine whether this treatment program is more or equally efficient to treat depression in the elderly as usual care and at lower cost and use of specialized care.
- Conditions
- Depression in Old Age
- Being tested
- Intervention group
- Keywords
- Depression, Elderly, Family Practice
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
see above
| Study group | Role | What they receive |
|---|---|---|
| Active treatment group | Experimental | Patients will meet in a joint consultation with their family physician and a psychiatrist for evaluation. Then it follows three treatment sessions with the family physician before a new joint consultation with the psychiatrist. The intervention ends with three more treatment sessions with the family physician. Receives: Behavioral: Intervention group |
| Control group | Active comparator | Patients belonging to family physicians who constitute the control group will be assessed and given treatment according to usual care. This may include treatment by the family physician, medication, referrals to specialized care. Receives: Behavioral: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a change in clinical significant depression
Change in depression as described by the Patient Health Questionnaire (PHQ-9). The questionnaire is a 9-item questionnaire, each with a 0-4 point scale. A change of 3,9 points in the sumscale is regarded significant.
Measured: At start and at 12 and 18 month following treatment
Secondary outcomes (2)
Number of patients with a change in the level of anxiety
Change in anxiety as described by the Generalized Anxiety Disorder 7-item score GAD-7. The questionnaire is a 7-item questionnaire, each with a 0-4 point scale. There is no consensus on which level of change is regarded significant.
Measured: At start and at 12 and 18 month following treatment
Number of Subjective Health Complaints among patients with depression
Change in subjective Health Complaints as described by the Subjective Health Complaints questionnaire. The questionnaire is a 9-item questionnaire, each with a 0-4 point scale. A change of 3,9 points in the sumscale is regarded significant. The questionnaire is a 29-item questionnaire, each with a 0-4 point scale. There is no consensus on which level of change is regarded significant.
Measured: At start and at 12 and 18 month following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start15 Sep 2019
- Primary completion30 Sep 2022
- Study completion30 Dec 2023
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 Depression in Old AgeStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- Cluster randomized controlled trial where family physicians are to be randomized into interventional or control group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik L Werner, University of Oslo
- Investigators
- Jørund Straand, PhD, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078282
- Sponsor's protocol ID
- LCKO001
- Status last verified
- Feb 2024
- First submitted
- 27 Aug 2019
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kvalbein-Olsen LC, Aakhus E, Haavet OR, Mdala I, Werner EL. Joint consultations in a structured GP-patient-geriatric-psychiatrist model for late-life depression: a cluster RCT. BMC Prim Care. 2025 Sep 29;26(1):297. doi: 10.1186/s12875-025-03002-w.
PubMed 41023858
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Collaborative Care in General Practice for Elderly Patients With Depression
- ClinicalTrials.gov ID
- NCT04078282
- Acronym / sponsor ID
- LCKO001
- Conditions
- Depression in Old Age
- Keywords
- Depression, Elderly, Family Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 6 Sep 2019 (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 first part of this study aims to identify the occurence of depression in the elderly. In the second part, older patients with depression will be invited to a collaborative care with his or her family physician and a psychiatrist specialized in psychiatry in the elderly in accordance with a study protocol. The intervention includes two sessions where the patient will meet the psychiatrist together with the family physician, and between the two sessions the patient will have three treatment sessions with the family physician based on the evaluation by the psychiatrist. Following the last session with the psychiatrist the intervention ends with three more treatment sessions with the family physician.
Detailed description
The frequency of depression in the elderly is little known and experiences from family practice indicate that older people not always communicate their mental health issues or present physical complaints which may arise from a state of depression. In this study we aim to register the occurence of depression among all patients at the age of 65 or older who visit their family physician. During a period of four weeks, all patients meeting the eligibility criteria will be asked to answer a questionnaire about mental and physic health issues. Those who respond in a manner that gives reasons to believe there is a depression will be contacted by their family physician to meet for a consultation and examination. If this examination confirms the diagnosis the patient will either be treated as usual by their family physician (control group) or be invited to a collaborative care with the family physician in cooperation with a psychiatrist who is specialized in psychiatry in the elderly (intervention group). In the control group the patients will receive usual care at their family physician or be referred to a psychiatrist or a psychologist if appropriate. In the intervention group the patients will have a evaluation session with the family physician and the psychiatrist together. Following this session, the patient and the family physician will meet for three treatment consultations based on the evaluation and recommendations given by the psychiatrist. Then there will be one more joint session with the patient, the family physician and the psychiatrist and the whole treatment program ends with three more treatment consultations at the family physician. - The aim of this intervention is to examine whether this treatment program is more or equally efficient to treat depression in the elderly as usual care and at lower cost and use of specialized care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial where family physicians are to be randomized into interventional or control group
| Arm | Type | Receives |
|---|---|---|
| Active treatment group | Experimental | Behavioral: Intervention groupPatients will meet in a joint consultation with their family physician and a psychiatrist for evaluation. Then it follows three treatment sessions with the family physician before a new joint consultation with the psychiatrist. The intervention ends with three more treatment sessions with the family physician. |
| Control group | Active comparator | Behavioral: Intervention groupPatients belonging to family physicians who constitute the control group will be assessed and given treatment according to usual care. This may include treatment by the family physician, medication, referrals to specialized care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- all patients visiting one of the collaborative family physicians during the enrollment period of four weeks
Key exclusion criteria (2 listed)
- cognitive dysfunction
- speaking Norwegian language
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 |
|---|---|---|
| Intervention groupsee above | Behavioural | Active treatment group, Control group |
Primary outcome
Number of patients with a change in clinical significant depression
Time frame: At start and at 12 and 18 month following treatment
Change in depression as described by the Patient Health Questionnaire (PHQ-9). The questionnaire is a 9-item questionnaire, each with a 0-4 point scale. A change of 3,9 points in the sumscale is regarded significant.
2 secondary outcomes
Number of patients with a change in the level of anxiety
Time frame: At start and at 12 and 18 month following treatment
Number of Subjective Health Complaints among patients with depression
Time frame: At start and at 12 and 18 month following treatment
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 Feb 2024.
- Derived from this study: PubMed 41023858Kvalbein-Olsen LC, Aakhus E, Haavet OR, Mdala I, Werner EL. Joint consultations in a structured GP-patient-geriatric-psychiatrist model for late-life depression: a cluster RCT. BMC Prim Care. 2025 Sep 29;26(1):297. doi: 10.1186/s12875-025-03002-w.
- 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. This study is not recruiting at the moment.
Jørund Straand, PhD study director
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Depression in Old Age, run by University of Oslo 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 1 inclusion and 2 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 Feb 2024. 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.
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?
Number of patients with a change in clinical significant depression (time frame: At start and at 12 and 18 month following treatment). 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 NCT04078282, 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 21 Feb 2024.