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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Consultations-Liaison; Behavioral: Collaborative care

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.

• Study Type: Interventional
• Enrollment (Actual): 389
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Mental Health Centre Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collabri Flex; Collaborative care	Behavioral: Collaborative 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
Experimental: Consultation-Liaison; Consultations with general practitioner	Behavioral: Consultations-Liaison; Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported degree of depression	Measured by Beck Depression Inventory (BDI-II)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported quality of life/well-being	Measured by WHO-5	6 months
Self-reported degree of anxiety	Measured by Beck anxiety Inventory (BAI)	6 months
Self-reported psychological stress	Measured by Symptom Checklist (SCL-90-R)	6 months
Self-reported functional impairment	Measured by Sheehan disability Scale (SDS)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sick leave	Obtained from the DREAM database	6 months
Sick leave	Obtained from the DREAM database	18 months
Self-reported health-related quality of life	Measured by EQ-5D	6 months
Self-reported health-related quality of life	Measured by EQ-5D	18 months
Employment	Obtained from the DREAM database	6 months
Employment	Obtained from the DREAM database	18 months
Self-reported degree of depression	Measured by Beck Depression Inventory (BDI-II)	18 months
Self-reported quality of life/well-being	Measured by WHO-5	18 months
Self-reported self-efficacy	Measured by personal control (IPQ-R scale) and two subscales from the Chronic Disease Self-Efficacy Scales; Obtain help from Comunity, Family, Friends Scale and Control/manage Depression Scale	6 months
Self-reported self-efficacy	Measured by personal control (IPQ-R scale) and two subscales from the Chronic Disease Self-Efficacy Scales; Obtain help from Comunity, Family, Friends Scale and Control/manage Depression Scale	18 months
Self-reported experience of support in recovery	Experience of support in recovery (INSPIRE)	6 months
Mental-health outpatient services	Obtained from LPR	6 months
Mental-health outpatient services	Obtained from LPR	18 months
Patient satisfaction	Self-reported experience of satisfaction with treatment (CSQ-8)	6 months
Self-reported degree of anxiety	Measured by Beck anxiety Inventory (BAI)	18 months
Self-reported psychological stress	Measured by Symptom Checklist (SCL-90-R)	18 months
Self-reported functional impairment	Measured by Sheehan disability Scale (SDS)	18 months

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Investigators: Principal Investigator: Lene F Eplov, MD, PhD, Research Unit, Mental Health Center Copenhagen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): March 29, 2021
• Study Completion (Actual): March 29, 2021

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Psychiatry; Collaborative care; General practitioner; Care manager; Consultation-liaison
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: Collabri Flex - Depression

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No