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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02678624
Other study ID # H-3-2013-203-A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 406
Est. completion date July 2020
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
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

Study Design


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 anxiety measured by the Beck Anxiety Inventory (BAI) The measure is self-reported At 15 months follow up after baseline
Other Degree of depression measured by the Beck Depression Inventory (BDI) 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 scale 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 anxiety measured by the Beck Anxiety Inventory (BAI) The measure is self-reported At 6 months follow up after baseline
Secondary Degree of depression measured by the Beck Depression Inventory (BDI) 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
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