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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)
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment according to the Collabri model | Experimental | 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 |
|
| Treatment as usual | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment according to the Collabri model | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of anxiety measured by the Beck Anxiety Inventory (BAI) | The measure is self-reported | At 6 months follow up after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of depression measured by the Beck Depression Inventory (BDI) | The measure is self-reported | At 6 months follow up after baseline |
| Psychological stress measured with the Symptom Checklist (SCL-92) |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of anxiety measured by the Beck Anxiety Inventory (BAI) | The measure is self-reported | At 15 months follow up after baseline |
| Degree of depression measured by the Beck Depression Inventory (BDI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lene F Eplov, MD PhD | Mental Health Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Centre Copenhagen | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33203365 | Derived | Curth NK, Brinck-Claussen UO, Hjorthoj C, Davidsen AS, Mikkelsen JH, Lau ME, Lundsteen M, Csillag C, Christensen KS, Jakobsen M, Bojesen AB, Nordentoft M, Eplov LF. Collaborative care for depression and anxiety disorders: results and lessons learned from the Danish cluster-randomized Collabri trials. BMC Fam Pract. 2020 Nov 18;21(1):234. doi: 10.1186/s12875-020-01299-3. | |
| 28814317 |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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|
The measure is self-reported
| At 6 months follow up after baseline |
| 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 |
The measure is self-reported
| At 15 months follow up after baseline |
| Psychological stress measured with the Symptom Checklist (SCL-92) | The measure is self-reported | At 15 months follow up after baseline |
| 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 |
| Quality of life measured with the WHO-5 scale | The measure is self-reported | At 6 months follow up after baseline |
| Quality of life measured with the WHO-5 scale | The measure is self-reported | At 15 months follow up after baseline |
| 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 |
| 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 |
| Side effects measured by the PRISE questionnaire | The measure is self-reported | At 6 months follow up after baseline |
| Side effects measured by the PRISE questionnaire | The measure is self-reported | At 15 months follow up after baseline |
| Health-related quality of life measured with the EQ-5D | The measure is self-reported | At 6 months follow up after baseline |
| Health-related quality of life measured with the EQ-5D | The measure is self-reported | At 15 months follow up after baseline |
| Functional impairment measured with Sheehan Disability Scale (SDS) | The measure is self-reported | At 6 months follow up after baseline |
| Functional impairment measured with Sheehan Disability Scale (SDS) | The measure is self-reported | At 15 months follow up after baseline |
| Sick leave | The measure is obtained from the Danish DREAM database | At 6 months follow up after baseline |
| Sick leave | The measure is obtained from the Danish DREAM database | At 15 months follow up after baseline |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Apathia | The measure is obtained through a semi-structured interview | At 6 months follow up after baseline |
| Apathia | The measure is obtained through a semi-structured interview | At 15 months follow up after baseline |
| Derived |
| Curth NK, Brinck-Claussen UO, Davidsen AS, Lau ME, Lundsteen M, Mikkelsen JH, Csillag C, Hjorthoj C, Nordentoft M, Eplov LF. Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials. Trials. 2017 Aug 16;18(1):382. doi: 10.1186/s13063-017-2120-3. |