Clinical trial NCT02678845: Project Collabri for Treatment of Depression
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Degree of depression measured by the Beck Depression Inventory (BDI)
timeFrame: At 6 months follow up after baseline
Secondary outcomes:
measure: Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
timeFrame: At 6 months follow up after baseline
measure: Psychological stress measured with the Symptom Checklist (SCL-92)
timeFrame: At 6 months follow up after baseline
measure: Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
timeFrame: At 6 months follow up after baseline
Other outcomes:
measure: Degree of depression measured by the Beck Depression Inventory (BDI)
timeFrame: At 15 months follow up after baseline
measure: Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
timeFrame: At 15 months follow up after baseline
measure: Psychological stress measured with the Symptom Checklist (SCL-92)
timeFrame: At 15 months follow up after baseline
measure: Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
timeFrame: At 15 months follow up after baseline
measure: Quality of life measured with the WHO-5
timeFrame: At 6 months follow up after baseline
measure: Quality of life measured with the WHO-5 scale
timeFrame: At 15 months follow up after baseline
measure: Personal and social performance measured with the Personal and Social Performance scale (PSP)
timeFrame: At 6 months follow up after baseline
measure: Personal and social performance measured with the Personal and Social Performance scale (PSP)
timeFrame: At 15 months follow up after baseline
measure: Side effects measured by the PRISE questionnaire
timeFrame: At 6 months follow up after baseline
measure: Side effects measured by the PRISE questionnaire
timeFrame: At 15 months follow up after baseline
measure: Health-related quality of life measured with the EQ-5D
timeFrame: At 6 months follow up after baseline
measure: Health-related quality of life measured with the EQ-5D
timeFrame: At 15 months follow up after baseline
measure: Functional impairment measured with Sheehan Disability Scale (SDS)
timeFrame: At 6 months follow up after baseline
measure: Functional impairment measured with Sheehan Disability Scale (SDS)
timeFrame: At 15 months follow up after baseline
measure: Sick leave
timeFrame: At 6 months follow up after baseline
measure: Sick leave
timeFrame: At 15 months follow up after baseline
measure: Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale
timeFrame: At 6 months follow up after baseline
measure: Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale
timeFrame: At 15 months follow up after baseline
measure: Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale
timeFrame: At 6 months follow up after baseline
measure: Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale
timeFrame: At 15 months follow up after baseline
measure: Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)
timeFrame: At 6 months follow up after baseline
measure: Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)
timeFrame: At 15 months follow up after baseline
measure: Apathia
timeFrame: At 6 months follow up after baseline
measure: Apathia
timeFrame: At 15 months follow up after baseline
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Centre Copenhagen
Study officials:
affiliation: Mental Health Center Copenhagen
name: Lene F Eplov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.