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

ID: NCT03113201
Status: Not yet recruiting
Phase: N/A
Start Date: May 01, 2017
First Submitted: April 10, 2017
Last Updated: April 10, 2017
Results: N/A
Sponsors & Collaborators: Mental Health Centre Copenhagen
Location: N/A
Conditions: Depression, Anxiety
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Study Description

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.
Condition or disease Intervention/treatment Phase

Anxiety

Depression

Behavioral: Collaborative care
Other Names
Behavioral: Consultations-Liaison
Other Names
N/A

Tracking Information

First Submitted DateApril 10, 2017
Last Update Posted DateApril 10, 2017
Anticipated Start DateMay 01, 2017
Anticipated Completion DateNovember 01, 2018
Anticipated Primary Completion DateNovember 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Self-reported degree of depression [Time Frame: 6 months]

    Measured by Beck Depression Inventory (BDI)

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Self-reported degree of anxiety [Time Frame: 6 months]

    Measured by Beck anxiety Inventory (BAI)

  • Self-reported psychological stress [Time Frame: 6 months]

    Measured by Symptom Checklist (SCL-92)

  • Self-reported functional impairment [Time Frame: 6 months]

    Measured by Sheehan disability Scale (SDS)

  • Self-reported quality of life [Time Frame: 6 months]

    Measured by WHO-5

  • Self-reported side effects [Time Frame: 6 months]

    Measured by PRISE

  • Sick leave [Time Frame: 6 months]

    Obtained from the DREAM database

  • Self-reported self-efficacy [Time Frame: 6 monts]

    Measured by personal control (IPQ-R scale) and two subscales from the Chronic Disease Self-Efficacy Scales (SECD-32); Obtain help from Comunity, Family, Friends Scale and Control/manage Depression Scale

  • Self-reported health-related quality of life [Time Frame: 6 months]

    Measured by EQ-5D

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleCollabri Flex - Effect of Collaborative Care for People With Depression in General Practice
Official TitleProjekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
240
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Anxiety
Depression
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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

Other Names
Behavioral: Consultations-Liaison

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

Other Names
Study Groups/Cohorts
Collabri Flex
Collaborative care

Consultation-Liaison
Consultations with general practitioner

Study Arms
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).

Arm Intervention/Treatment
Experimental Collabri Flex
Collaborative care
Behavioral : Collaborative care
Experimental Consultation-Liaison
Consultations with general practitioner
Behavioral : Consultations-Liaison

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment240
Completion DateNovember 01, 2018
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 (12) 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.
- Patients that wish to continue current psychological or psychiatric treatment due to anxiety or depression
- For patients in the Collabri Flex group: Patients with depression who wants treat-ment cf. the psychologist scheme (Psykologordningen) and do not want the refferal to the psychologist preceded by other treatment, cf. the Collabri Flex model assessed by the GP
- If the patient before or at the first point of contact with the GP after inclusion by care manager is referred to treatment as a part of the secondary psychiatric care system
- Patients who are assessed by the GP 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 GP.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03113201
Other Study ID Numbers
Collabri Flex - Depression
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible PartyLene Falgaard Eplov, Mental Health Centre Copenhagen
Study Sponsor
Mental Health Centre Copenhagen
Collaborators
Not Available
Investigators
Not Available