Project Collabri for Treatment of Depression

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678845
• Other study ID #: H-3-2013-203-D
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: July 2020

Study information

• Verified date: February 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: July 2020
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Mental Health Centre Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Degree of depression measured by the Beck Depression Inventory (BDI)	The measure is self-reported	At 15 months follow up after baseline
Other	Degree of anxiety measured by the Beck Anxiety Inventory (BAI)	The measure is self-reported	At 15 months follow up after baseline
Other	Psychological stress measured with the Symptom Checklist (SCL-92)	The measure is self-reported	At 15 months follow up after baseline
Other	Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline
Other	Quality of life measured with the WHO-5	The measure is self-reported	At 6 months follow up after baseline
Other	Quality of life measured with the WHO-5 scale	The measure is self-reported	At 15 months follow up after baseline
Other	Personal and social performance measured with the Personal and Social Performance scale (PSP)	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline
Other	Personal and social performance measured with the Personal and Social Performance scale (PSP)	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline
Other	Side effects measured by the PRISE questionnaire	The measure is self-reported	At 6 months follow up after baseline
Other	Side effects measured by the PRISE questionnaire	The measure is self-reported	At 15 months follow up after baseline
Other	Health-related quality of life measured with the EQ-5D	The measure is self-reported	At 6 months follow up after baseline
Other	Health-related quality of life measured with the EQ-5D	The measure is self-reported	At 15 months follow up after baseline
Other	Functional impairment measured with Sheehan Disability Scale (SDS)	The measure is self-reported	At 6 months follow up after baseline
Other	Functional impairment measured with Sheehan Disability Scale (SDS)	The measure is self-reported	At 15 months follow up after baseline
Other	Sick leave	The measure is obtained from the Danish DREAM database	At 6 months follow up after baseline
Other	Sick leave	The measure is obtained from the Danish DREAM database	At 15 months follow up after baseline
Other	Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 6 months follow up after baseline
Other	Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 15 months follow up after baseline
Other	Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 6 months follow up after baseline
Other	Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 15 months follow up after baseline
Other	Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)	The measure is self-reported	At 6 months follow up after baseline
Other	Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)	The measure is self-reported	At 15 months follow up after baseline
Other	Apathia	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline
Other	Apathia	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline
Primary	Degree of depression measured by the Beck Depression Inventory (BDI)	The measure is self-reported	At 6 months follow up after baseline
Secondary	Degree of anxiety measured by the Beck Anxiety Inventory (BAI)	The measure is self-reported	At 6 months follow up after baseline
Secondary	Psychological stress measured with the Symptom Checklist (SCL-92)	The measure is self-reported	At 6 months follow up after baseline
Secondary	Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline