Project Collabri for Treatment of Depression

NCT ID: NCT02678845

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2020-07-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Treatment according to the Collabri model

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Lene Falgaard Eplov

Senior researcher, PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lene F Eplov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Center Copenhagen

Locations

Mental Health Centre Copenhagen

Copenhagen, , Denmark

Countries

Denmark

References

Brinck-Claussen UO, Curth NK, Christensen KS, Davidsen AS, Mikkelsen JH, Lau ME, Lundsteen M, Csillag C, Hjorthoj C, Nordentoft M, Eplov LF. Improving the precision of depression diagnosis in general practice: a cluster-randomized trial. BMC Fam Pract. 2021 May 7;22(1):88. doi: 10.1186/s12875-021-01432-w.

Reference Type: DERIVED

PMID: 33962564 (View on PubMed)

Curth NK, Brinck-Claussen UO, Hjorthoj C, Davidsen AS, Mikkelsen JH, Lau ME, Lundsteen M, Csillag C, Christensen KS, Jakobsen M, Bojesen AB, Nordentoft M, Eplov LF. Collaborative care for depression and anxiety disorders: results and lessons learned from the Danish cluster-randomized Collabri trials. BMC Fam Pract. 2020 Nov 18;21(1):234. doi: 10.1186/s12875-020-01299-3.

Reference Type: DERIVED

PMID: 33203365 (View on PubMed)

Brinck-Claussen UO, Curth NK, Davidsen AS, Mikkelsen JH, Lau ME, Lundsteen M, Csillag C, Christensen KS, Hjorthoj C, Nordentoft M, Eplov LF. Collaborative care for depression in general practice: study protocol for a randomised controlled trial. Trials. 2017 Jul 21;18(1):344. doi: 10.1186/s13063-017-2064-7.

Reference Type: DERIVED

PMID: 28732523 (View on PubMed)

Other Identifiers

H-3-2013-203-D

Identifier Type: -

Identifier Source: org_study_id