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Collabri Flex - Effect of Collaborative Care for People With Depression in General Practice

Projekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03113201
Acronym
Collabri Flex
Enrollment
389
Registered
2017-04-13
Start date
2018-01-15
Completion date
2021-03-29
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Collaborative care, Care manager, Anxiety, Psychiatry, Consultation-liaison, General practitioner

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.

Interventions

BEHAVIORALCollaborative care

Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation and medication according to a stepped care model

Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

Sponsors

Amager Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported degree of depression6 monthsMeasured by Beck Depression Inventory (BDI-II)

Secondary

MeasureTime frameDescription
Self-reported degree of anxiety6 monthsMeasured by Beck anxiety Inventory (BAI)
Self-reported psychological stress6 monthsMeasured by Symptom Checklist (SCL-90-R)
Self-reported functional impairment6 monthsMeasured by Sheehan disability Scale (SDS)
Self-reported quality of life/well-being6 monthsMeasured by WHO-5

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORLene F Eplov, MD, PhD

Research Unit, Mental Health Center Copenhagen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026