Clinical trial NCT02678624: Project Collabri for Treatment of Anxiety
Official title: Project Collabri. The Effects of a Danish Model of Collaborative Care for People With Anxiety in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety
Social Phobia
Panic Disorder
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility 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

Primary outcomes:
measure: Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
timeFrame: At 6 months follow up after baseline
Secondary outcomes:
measure: Degree of depression measured by the Beck Depression Inventory (BDI)
timeFrame: At 6 months follow up after baseline
measure: Psychological stress measured with the Symptom Checklist (SCL-92)
timeFrame: At 6 months follow up after baseline
measure: Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
timeFrame: At 6 months follow up after baseline
Other outcomes:
measure: Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
timeFrame: At 15 months follow up after baseline
measure: Degree of depression measured by the Beck Depression Inventory (BDI)
timeFrame: At 15 months follow up after baseline
measure: Psychological stress measured with the Symptom Checklist (SCL-92)
timeFrame: At 15 months follow up after baseline
measure: Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
timeFrame: At 15 months follow up after baseline
measure: Quality of life measured with the WHO-5 scale
timeFrame: At 6 months follow up after baseline
measure: Quality of life measured with the WHO-5 scale
timeFrame: At 15 months follow up after baseline
measure: Personal and social performance measured with the Personal and Social Performance scale (PSP)
timeFrame: At 6 months follow up after baseline
measure: Personal and social performance measured with the Personal and Social Performance scale (PSP)
timeFrame: At 15 months follow up after baseline
measure: Side effects measured by the PRISE questionnaire
timeFrame: At 6 months follow up after baseline
measure: Side effects measured by the PRISE questionnaire
timeFrame: At 15 months follow up after baseline
measure: Health-related quality of life measured with the EQ-5D
timeFrame: At 6 months follow up after baseline
measure: Health-related quality of life measured with the EQ-5D
timeFrame: At 15 months follow up after baseline
measure: Functional impairment measured with Sheehan Disability Scale (SDS)
timeFrame: At 6 months follow up after baseline
measure: Functional impairment measured with Sheehan Disability Scale (SDS)
timeFrame: At 15 months follow up after baseline
measure: Sick leave
timeFrame: At 6 months follow up after baseline
measure: Sick leave
timeFrame: At 15 months follow up after baseline
measure: Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale
timeFrame: At 6 months follow up after baseline
measure: Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale
timeFrame: At 15 months follow up after baseline
measure: Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale
timeFrame: At 6 months follow up after baseline
measure: Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale
timeFrame: At 15 months follow up after baseline
measure: Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)
timeFrame: At 6 months follow up after baseline
measure: Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)
timeFrame: At 15 months follow up after baseline
measure: Apathia
timeFrame: At 6 months follow up after baseline
measure: Apathia
timeFrame: At 15 months follow up after baseline
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Centre Copenhagen
Study officials:
affiliation: Mental Health Center Copenhagen
name: Lene F Eplov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.