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Project Collabri for Treatment of Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678624
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mental Health Centre Copenhagen

Brief Summary:
The purpose of this study is to determine whether treatment of patients with anxiety according to the Collabri Model is more effective in reducing symptoms compared to treatment as usual (TAU)

Condition or disease Intervention/treatment Phase
Generalized Anxiety Social Phobia Panic Disorder Other: Treatment according to the Collabri model Not Applicable

Detailed Description:

Background:

Depression and anxiety are common diseases often treated in general practice. However, there are obstacles for optimal treatment e.g. a lack of continuity in disease management, organized collaboration between primary and secondary care and access to psychotherapy. Previous collaborative care studies have shown significant improvements in treatment outcomes for patients with depression and anxiety in primary care; however studies have yet not been carried out in a Danish context. Thus, the Collabri-model for collaborative care for panic disorder, generalized anxiety, social phobia and depression has been developed. The model includes: a multi-professional approach to treatment including a care manager (e.g. a psychiatric nurse), enhanced inter-professional communication, scheduled monitoring and review and structured treatment plans.

Objective:

To investigate whether treatment according to the Collabri-model have an effect on symptoms for people with anxiety disorders.

Methods/design:

Three cluster-randomized, clinical trials are set up to investigate treatment according to the Collabri-model compared to treatment as usual for 364 patients diagnosed with panic disorder, generalized anxiety and social phobia respectively from general practices in the Capital Region of Denmark. For all studies, the primary outcome is anxiety symptoms measured with Beck Anxiety Inventory (BAI) at 6 months.

Results/discussion:

The results will contribute new knowledge on collaborative care for depression and anxiety disorders in Danish conditions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Project Collabri. The Effects of a Danish Model of Collaborative Care for People With Anxiety in General Practice
Study Start Date : November 2014
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Treatment according to the Collabri model
Participants in this group will recive treatment according to the Collabri model which is a Danish model for collaborative care between primary and secondary care for depression, social phobia, generalized anxiety and panic disorder
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.

No Intervention: Treatment as usual
Control group. Participants in this group will recive treatment as usual. This means that participants will recive treatment corresponding to what their GP normally would offer as treatment. E.g. this could be refferal to a psychologist or psychiatrist and/or medicine.



Primary Outcome Measures :
  1. Degree of anxiety measured by the Beck Anxiety Inventory (BAI) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported


Secondary Outcome Measures :
  1. Degree of depression measured by the Beck Depression Inventory (BDI) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  2. Psychological stress measured with the Symptom Checklist (SCL-92) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  3. Functional impairment measured with the Global Assessment of Functioning (GAF-F split version) [ Time Frame: At 6 months follow up after baseline ]
    The measure is obtained through a semi-structured interview


Other Outcome Measures:
  1. Degree of anxiety measured by the Beck Anxiety Inventory (BAI) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  2. Degree of depression measured by the Beck Depression Inventory (BDI) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  3. Psychological stress measured with the Symptom Checklist (SCL-92) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  4. Functional impairment measured with the Global Assessment of Functioning (GAF-F split version) [ Time Frame: At 15 months follow up after baseline ]
    The measure is obtained through a semi-structured interview

  5. Quality of life measured with the WHO-5 scale [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  6. Quality of life measured with the WHO-5 scale [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  7. Personal and social performance measured with the Personal and Social Performance scale (PSP) [ Time Frame: At 6 months follow up after baseline ]
    The measure is obtained through a semi-structured interview

  8. Personal and social performance measured with the Personal and Social Performance scale (PSP) [ Time Frame: At 15 months follow up after baseline ]
    The measure is obtained through a semi-structured interview

  9. Side effects measured by the PRISE questionnaire [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  10. Side effects measured by the PRISE questionnaire [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  11. Health-related quality of life measured with the EQ-5D [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  12. Health-related quality of life measured with the EQ-5D [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  13. Functional impairment measured with Sheehan Disability Scale (SDS) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  14. Functional impairment measured with Sheehan Disability Scale (SDS) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  15. Sick leave [ Time Frame: At 6 months follow up after baseline ]
    The measure is obtained from the Danish DREAM database

  16. Sick leave [ Time Frame: At 15 months follow up after baseline ]
    The measure is obtained from the Danish DREAM database

  17. Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  18. Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  19. Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  20. Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  21. Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R) [ Time Frame: At 6 months follow up after baseline ]
    The measure is self-reported

  22. Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R) [ Time Frame: At 15 months follow up after baseline ]
    The measure is self-reported

  23. Apathia [ Time Frame: At 6 months follow up after baseline ]
    The measure is obtained through a semi-structured interview

  24. Apathia [ Time Frame: At 15 months follow up after baseline ]
    The measure is obtained through a semi-structured interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02678624


Locations
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Denmark
Mental Health Centre Copenhagen
Copenhagen, Denmark
Sponsors and Collaborators
Mental Health Centre Copenhagen
Investigators
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Principal Investigator: Lene F Eplov, MD PhD Mental Health Center Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT02678624    
Other Study ID Numbers: H-3-2013-203-A
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anxiety Disorders
Panic Disorder
Phobia, Social
Mental Disorders
Phobic Disorders