Clinical trial NCT03113201: Collabri Flex - Effect of Collaborative Care for People with Depression in General Practice
Official title: Projekt Collabri Flex - the Effect of a Danish Model for Collaborative Care for People with Depression in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Collaborative care
Care manager
Anxiety
Psychiatry
Consultation-liaison
General practitioner
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 389
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 aim of the study Collabri Flex is to:

* Develop a Danish model for collaborative care for patients with depression in general practice, based on past experience gained in the Collabri Project.
* Examine the impact of this model compared with liaison-consultation for people with depression in a randomized controlled design from selected endpoints.

Detailed description: The Collabri Flex model for Collaborative Care takes point of departure in the earlier study Collabri. It is changed according to gathered information under the first study of the Collabri model in order to achieve a Danish Collaborative Care model easier to implement.

The aims of Project Collabri Flex are to:

* Develop a flexible model for collaborative care (the Collabri Flex model) for patients with depression.
* Study the effects of this Collabri Flex model against consultation liaison in a randomized design on selected outcomes.

In Collabri the treatment is in line with a set of general treatment principles relevant for collaborative care interventions. The patients in the intervention group are offered cognitive behavioral therapy (CBT), psychoeducation and medication according to a stepped care model by a care manager refering to the general practitioner.

The Collabri Flex study is set up as a researcher-blinded individually randomized controlled trial with participation of an intervention group (treatment according to the Collabri Flex model) and a consultation liaison group.

This study will contribute with new knowledge on collaborative care interventions in a Scandinavian context.

Eligibility criteria: Inclusion Criteria:

* Danish speaking
* Diagnosis of current depression based on the Mini International Neuropsychiatric Interview (MINI) by care managers that have been trained in using MINI in close collaboration with the psychiatrist/psychologist.
* 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 the GP
* Psychotic condition detected in the MINI and/or by the GP
* Patients with a diagnosis of dementia
* Alcohol or substance misuse that hinders the person participating in Collabri treat-ment as assessed by the practitioner or care manager at inclusion interview
* If the patient has been referred or is recommended referral to secondary care treatment (mental health center) or psychiatrist in private practice
* Patients who are assessed by the GP as medically unstable making it impossible for the patient to adhere to treatment
* Bipolar affective disorder as assessed in the MINI and/or by the GP
* Pregnancy

For patients in the Collabri Flex group:

* Patients with depression who wants treatment cf. the psychologist scheme (Psykologordningen) or similar treatment and do not want the refferal to the psychologist preceded by other treatment, cf. the Collabri Flex model assessed by the GP
* Patients that wish to continue current psychological or psychiatric treatment due to anxiety or depression

Primary outcomes:
measure: Self-reported degree of depression
timeFrame: 6 months
Secondary outcomes:
measure: Self-reported degree of anxiety
timeFrame: 6 months
measure: Self-reported psychological stress
timeFrame: 6 months
measure: Self-reported functional impairment
timeFrame: 6 months
measure: Self-reported quality of life/well-being
timeFrame: 6 months
Other outcomes:
measure: Sick leave
timeFrame: 6 months
measure: Sick leave
timeFrame: 18 months
measure: Self-reported self-efficacy
timeFrame: 6 months
measure: Self-reported self-efficacy
timeFrame: 18 months
measure: Self-reported health-related quality of life
timeFrame: 6 months
measure: Self-reported health-related quality of life
timeFrame: 18 months
measure: Self-reported experience of support in recovery
timeFrame: 6 months
measure: Employment
timeFrame: 6 months
measure: Employment
timeFrame: 18 months
measure: Mental-health outpatient services
timeFrame: 6 months
measure: Mental-health outpatient services
timeFrame: 18 months
measure: Patient satisfaction
timeFrame: 6 months
measure: Self-reported degree of depression
timeFrame: 18 months
measure: Self-reported degree of anxiety
timeFrame: 18 months
measure: Self-reported psychological stress
timeFrame: 18 months
measure: Self-reported functional impairment
timeFrame: 18 months
measure: Self-reported quality of life/well-being
timeFrame: 18 months
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Centre Copenhagen
Study officials:
affiliation: Research Unit, Mental Health Center Copenhagen
name: Lene F Eplov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curth NK, Brinck-Claussen U, Jorgensen KB, Rosendal S, Hjorthoj C, Nordentoft M, Eplov LF. Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials). Trials. 2019 Oct 25;20(1):607. doi: 10.1186/s13063-019-3657-0.