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Completed

NCT Number: NCT03113201

Collabri Flex - Effect of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Centre Copenhagen

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collaborative care

Behavioral

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

Consultations-Liaison

Behavioral

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

Primary outcomes

  1. Self-reported degree of depression

    Time frame: 6 months

    Measured by Beck Depression Inventory (BDI-II)

Secondary outcomes

  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/well-being

    Time frame: 6 months

    Measured by WHO-5

Other outcomes

  1. Sick leave

    Time frame: 6 months

    Obtained from the DREAM database

  2. Sick leave

    Time frame: 18 months

    Obtained from the DREAM database

  3. Self-reported self-efficacy

    Time frame: 6 months

    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

  4. Self-reported self-efficacy

    Time frame: 18 months

    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

  5. Self-reported health-related quality of life

    Time frame: 6 months

    Measured by EQ-5D

  6. Self-reported health-related quality of life

    Time frame: 18 months

    Measured by EQ-5D

  7. Self-reported experience of support in recovery

    Time frame: 6 months

    Experience of support in recovery (INSPIRE)

  8. Employment

    Time frame: 6 months

    Obtained from the DREAM database

  9. Employment

    Time frame: 18 months

    Obtained from the DREAM database

  10. Mental-health outpatient services

    Time frame: 6 months

    Obtained from LPR

  11. Mental-health outpatient services

    Time frame: 18 months

    Obtained from LPR

  12. Patient satisfaction

    Time frame: 6 months

    Self-reported experience of satisfaction with treatment (CSQ-8)

  13. Self-reported degree of depression

    Time frame: 18 months

    Measured by Beck Depression Inventory (BDI-II)

  14. Self-reported degree of anxiety

    Time frame: 18 months

    Measured by Beck anxiety Inventory (BAI)

  15. Self-reported psychological stress

    Time frame: 18 months

    Measured by Symptom Checklist (SCL-90-R)

  16. Self-reported functional impairment

    Time frame: 18 months

    Measured by Sheehan disability Scale (SDS)

  17. Self-reported quality of life/well-being

    Time frame: 18 months

    Measured by WHO-5

Sponsors and collaborators

Lead sponsor

Amager Hospital

Other

Registry information

Official study title

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

Acronym: Collabri Flex

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2017
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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