Project Collabri for Treatment of Depression

ID: NCT02678845
Status: Active, not recruiting
Phase: N/A
Start Date: November 01, 2014
First Submitted: February 07, 2016
Last Updated: December 05, 2017
Results: N/A
Sponsors & Collaborators: Mental Health Centre Copenhagen
Location: Denmark
Conditions: Depression
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Study Description

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)

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.
Condition or disease Intervention/treatment Phase

Depression

Other: Treatment according to the Collabri model
Other Names
N/A

Tracking Information

First Submitted DateFebruary 07, 2016
Last Update Posted DateDecember 05, 2017
Start DateNovember 01, 2014
Anticipated Completion DateMarch 01, 2018
Primary Completion DateJuly 01, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Degree of depression measured by the Beck Depression Inventory (BDI) [Time Frame: At 6 months follow up after baseline]

    The measure is self-reported

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Degree of anxiety measured by the Beck Anxiety Inventory (BAI) [Time Frame: At 6 months follow up after baseline]

    The measure is self-reported

  • Psychological stress measured with the Symptom Checklist (SCL-92) [Time Frame: At 6 months follow up after baseline]

    The measure is self-reported

  • 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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleProject Collabri for Treatment of Depression
Official TitleProject Collabri. The Effect of a Collaborative Care Model for Treatment of Depression in Primary Care in Denmark - A Cluster Randomized Clinical Superiority Trial
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)

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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
480
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Depression
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
Study Groups/Cohorts
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

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.

Study Arms
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.

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

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment480
Completion DateMarch 01, 2018
Eligibility 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Denmark

Administrative Information

NCT Number:NCT02678845
Other Study ID Numbers
H-3-2013-203-D
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyLene Falgaard Eplov, Mental Health Centre Copenhagen
Study Sponsor
Mental Health Centre Copenhagen
Collaborators
Not Available
Investigators
Principal Investigator
Lene F Eplov, MD PhD
Mental Health Center Copenhagen