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Project Collabri for Treatment of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678845
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Lene Falgaard Eplov, Mental Health Centre Copenhagen

Brief Summary:
The purpose of this study is to determine whether treatment of patients with depression according to the Collabri Model is more effective in reducing symptoms compared to treatment as usual (TAU)

Condition or disease Intervention/treatment Phase
Depression Other: Treatment according to the Collabri model Not Applicable

Detailed Description:

Background:

Depression is a common disease mostly treated in general practice. Diagnose and evidence based treatment in general practice today is not optimal (e.g. lack of continuity in disease management and lack of treatment opportunities).

International studies show effect of collaborative care on depression, but is not directly applicable into a Danish context.

A Danish model for collaborative care treatment of people with depression, generalized anxiety disorder, social phobia and panic disorder (the Collabri Model) is developed. The Collabri model consists of a multi-professional approach to treatment, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan.

Objectives:

to investigate the effect of the Collabri model for depression and further investigate two methods for detection of depression; standard detection and case finding.

Methods:

Two researcher-blinded cluster-randomized controlled studies with an intervention group (treatment according to the Collabri model) and a control group (TAU). Participants are 480 patients with depression consulting their general practitioner.

Results:

Primary outcome for the collaborative care study on depression is depression symptoms, measured with BDI at 6 months.

Discussion:

The results will contribute new knowledge on collaborative care for depression and anxiety in Danish conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Project Collabri. The Effect of a Collaborative Care Model for Treatment of Depression in Primary Care in Denmark - A Cluster Randomized Clinical Superiority Trial
Study Start Date : November 2014
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment according to the Collabri model
Participants in this group will recive treatment according to the Collabri model which is a Danish model for collaborative care between primary and secondary care for depression, social phobia, generalized anxiety and panic disorder
Other: Treatment according to the Collabri model
The Collabri Model is a complex intervention and consists of a number of treatment modalities. The Collabri Model includes the following elements: A multi-professional approach to treatment including a care manager, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan. It further integrates: Recruitment of staff with psychiatric experience, training of general practitioner and care manager, use of instruments for detection and follow-up, education and treatment of the patient, supervision from a psychiatric specialist, guided self-help, patient- and relative involvement and a stepped care approach to treatment where treatment is always commenced on the least invasive and least resource-demanding level.

No Intervention: Treatment as usual
Control group. Participants in this group will recive treatment as usual. This means that participants will recive treatment corresponding to what their GP normally would offer as treatment. E.g. this could be refferal to a psychologist or psychiatrist and/or medicine.



Primary Outcome Measures :
  1. Degree of depression measured by the Beck Depression Inventory (BDI) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported


Secondary Outcome Measures :
  1. Degree of anxiety measured by the Beck Anxiety Inventory (BAI) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  2. Psychological stress measured with the Symptom Checklist (SCL-92) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  3. Functional impairment measured with the Global Assessment of Functioning (GAF-F split version) [ Time Frame: At 6 months follow up after baseline ]
    The measure is obtained through a semi-structured interview


Other Outcome Measures:
  1. Degree of depression measured by the Beck Depression Inventory (BDI) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  2. Degree of anxiety measured by the Beck Anxiety Inventory (BAI) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  3. Psychological stress measured with the Symptom Checklist (SCL-92) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  4. Functional impairment measured with the Global Assessment of Functioning (GAF-F split version) [ Time Frame: At 15 months follow up after baseline ]
    The measure is obtained through a semi-structured interview

  5. Quality of life measured with the WHO-5 [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  6. Quality of life measured with the WHO-5 scale [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  7. Personal and social performance measured with the Personal and Social Performance scale (PSP) [ Time Frame: At 6 months follow up after baseline ]
    The measure is obtained through a semi-structured interview

  8. Personal and social performance measured with the Personal and Social Performance scale (PSP) [ Time Frame: At 15 months follow up after baseline ]
    The measure is obtained through a semi-structured interview

  9. Side effects measured by the PRISE questionnaire [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  10. Side effects measured by the PRISE questionnaire [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  11. Health-related quality of life measured with the EQ-5D [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  12. Health-related quality of life measured with the EQ-5D [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  13. Functional impairment measured with Sheehan Disability Scale (SDS) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  14. Functional impairment measured with Sheehan Disability Scale (SDS) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  15. Sick leave [ Time Frame: At 6 months follow up after baseline ]
    The measure is obtained from the Danish DREAM database

  16. Sick leave [ Time Frame: At 15 months follow up after baseline ]
    The measure is obtained from the Danish DREAM database

  17. Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  18. Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  19. Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  20. Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  21. Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  22. Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  23. Apathia [ Time Frame: At 6 months follow up after baseline ]
    The measure is obtained through a semi-structured interview

  24. Apathia [ Time Frame: At 15 months follow up after baseline ]
    The measure is obtained through a semi-structured interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18+ years
  • Danish speaking
  • Diagnosis of current depression using the Mini International Neuropsychiatric Interview (MINI) (DSM IV) by researchers that have been trained in using MINI and according to the ICD-10 criteria or when diagnosed by GP after conference with a psychiatrist in Project Collabri
  • The patient has given her/his written informed consent to participate in the trial at the described terms

Exclusion Criteria:

  • High risk of suicide assessed in the Mini International Neuropsychiatric Interview (MINI) and/or by general practitioner
  • Psychotic condition detected in the MINI and/or by general practitioner
  • Patients with a diagnosis of dementia
  • Pregnancy
  • Alcohol or substance misuse that hinders the person participating in Collabri treatment as assessed by the practitioner or researcher at inclusion interview
  • Patients that are in current psychological or psychiatric treatment due to anxiety or depression
  • Patients with a pending disability pension case
  • Patients who have been treated for anxiety or depression within the last 6 months
  • For patients in the intervention group: Patients with depression who wants treatment cf. the Danish psychologist scheme and do not want the reference to the psychologist preceded by other treatment, cf. the Collabri model
  • For patients in the intervention group: If the patient at the first point of contact with the general practitioner after inclusion by a research assistant is referred to treatment as a part of the secondary psychiatric care system.
  • Patients who are assessed by the general practitioner as medically unstable making it impossible for the patient to adhere to treatment
  • OCD, PTSD, bipolar affective disorder as assessed in the MINI and/or by the general practitioner

Information from the National Library of Medicine

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): NCT02678845


Locations
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Denmark
Mental Health Centre Copenhagen
Copenhagen, Denmark
Sponsors and Collaborators
Mental Health Centre Copenhagen
Investigators
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Principal Investigator: Lene F Eplov, MD PhD Mental Health Center Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lene Falgaard Eplov, Senior researcher, PhD, MD, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT02678845    
Other Study ID Numbers: H-3-2013-203-D
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders