The Use of Collaborative Care in General Practice for Elderly Patients With Depression
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|ClinicalTrials.gov Identifier: NCT04078282|
Recruitment Status : Not yet recruiting
First Posted : September 5, 2019
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression in Old Age||Behavioral: Intervention group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cluster randomized controlled trial where family physicians are to be randomized into interventional or control group|
|Masking:||None (Open Label)|
|Official Title:||The Use of Collaborative Care in General Practice for Elderly Patients With Depression|
|Estimated Study Start Date :||September 15, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Active treatment group
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.
Behavioral: Intervention group
Active Comparator: Control group
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.
Behavioral: Intervention group
- Number of patients with a change in clinical significant depression [ Time Frame: At start and at 12 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.
- Number of patients with a change in the level of anxiety [ Time Frame: At start and at 12 month following treatment ]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.
- Number of Subjective Health Complaints among patients with depression [ Time Frame: At start and at 12 month following treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078282
|Contact: Lars C Kvalbein-Olsen, MD||+47 firstname.lastname@example.org|
|Contact: Erik L. Werner, PhD||+47 email@example.com|
|Study Director:||Jørund Straand, PhD||University of Oslo|