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

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ClinicalTrials.gov Identifier: NCT03113201
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Lene Falgaard Eplov, Mental Health Centre Copenhagen

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Collaborative care Behavioral: Consultations-Liaison Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Projekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Self-reported degree of depression [ Time Frame: 6 months ]
    Measured by Beck Depression Inventory (BDI-II)


Secondary Outcome Measures :
  1. Self-reported degree of anxiety [ Time Frame: 6 months ]
    Measured by Beck anxiety Inventory (BAI)

  2. Self-reported psychological stress [ Time Frame: 6 months ]
    Measured by Symptom Checklist (SCL-90-R)

  3. Self-reported functional impairment [ Time Frame: 6 months ]
    Measured by Sheehan disability Scale (SDS)

  4. Self-reported quality of life [ Time Frame: 6 months ]
    Measured by WHO-5


Other Outcome Measures:
  1. Sick leave [ Time Frame: 6 months ]
    Obtained from the DREAM database

  2. 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

  3. Self-reported health-related quality of life [ Time Frame: 6 months ]
    Measured by EQ-5D

  4. Self-reported experience of support in recovery [ Time Frame: 6 months ]
    Experience of support in recovery (INSPIRE)

  5. Employment [ Time Frame: 6 months ]
    Obtained from the DREAM database

  6. Mental-health outpatient services [ Time Frame: 6 months ]
    Obtained from LPR

  7. Patient satisfaction [ Time Frame: 6 months ]
    Self-reported experience of satisfaction with treatment (CSQ-8)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113201


Contacts
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Contact: Lene F Eplov, MD, PhD +45 38647461 Lene.Falgaard.Eplov@regionh.dk
Contact: Nadja Kehler Curth, MSc +4551467310 nadja.kehler.curth.01@regionh.dk

Locations
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Denmark
Mental Health Centre Copenhagen Recruiting
Copenhagen, Denmark
Contact: Lene F Eplov, MD, PhD    0045 38647461    lene.falgaard.eplov@regionh.dk   
Sponsors and Collaborators
Mental Health Centre Copenhagen
Investigators
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Principal Investigator: Lene F Eplov, MD, PhD Research Unit, Mental Health Center Copenhagen

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Responsible Party: Lene Falgaard Eplov, MD, PhD, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT03113201     History of Changes
Other Study ID Numbers: Collabri Flex - Depression
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lene Falgaard Eplov, Mental Health Centre Copenhagen:
Depression
Collaborative care
Care manager
Anxiety
Psychiatry
Consultation-liaison
General practitioner
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders