Panic Disorder Clinical Trial
Official title:
Project Collabri. The Effects of a Danish Model of Collaborative Care for People With Anxiety in General Practice
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 |
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 |
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)
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Mental Health Centre Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark |
Denmark,
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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