Agoraphobia, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Post Traumatic Stress Disorder, Social Phobia
Conditions
Keywords
Anxiety, Collaborative care, Consultation-liaison, General practitioner, Psychiatry
Brief summary
The aim of the study Collabri Flex is to: * Develop a Danish model for collaborative care for patients with anxiety in general practice, based on past experience gained in the Collabri Project. * Examine the impact of this model compared with liaison-consultation for people with anxiety in a randomized controlled design from selected endpoints.
Detailed description
The Collabri Flex model for Collaborative Care takes point of departure in the earlier study Collabri. It is changed according to gathered information under the first study of the Collabri model in order to achieve a Danish Collaborative Care model easier to implement. The aims of Project Collabri Flex are to: * Develop a flexible model for collaborative care (the Collabri Flex model) for patients with anxiety. * Study the effects of this Collabri Flex model against consultation liaison in a randomized design on selected outcomes. In Collabri the treatment is in line with a set of general treatment principles relevant for collaborative care interventions. The patients in the intervention group are offered cognitive behavioral therapy (CBT), psychoeducation and medication according to at stepped care model by a care manager refering to the general practitioner. The Collabri Flex study is set up as a researcher-blinded individually randomized controlled trial with participation of an intervention group (treatment according to the Collabri Flex model) and a consultation liaison group. This study will contribute with new knowledge on collaborative care interventions in a Scandinavian context.
Interventions
BEHAVIORALCollaborative care
Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation, medication according to a stepped care model
BEHAVIORALConsultations-Liaison
Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).
Sponsors
Amager Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: 18+ years * Danish speaking * Diagnosis of current anxiety in the form of panic disorder, generalized anxiety, PTSD, agoraphobia, OCD or social phobia based on the Mini International Neuropsychiatric Interview (MINI) by care manager that have been trained in using MINI. Patients can be referred from the GP on the basis of panic disorder, generalized anxiety, social phobia, OCD, PTSD, agoraphobia or depression diagnosis * 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 the GP * Psychotic condition assessed in the MINI and/or by the GP * Patients with a diagnosis of dementia * Alcohol or substance misuse that will hinder the person's participation in Collabri treatment assessed by the practitioner or care manager at inclusion interview * If the patient has been referred or is recommended referral to secondary care treatment (mental health center) or psychiatrist in private practice * Patients who are assessed by the GP as medically unstable making it impossible for the patient to adhere to treatment * Bipolar affective disorder as assessed in the MINI and/or by the GP * Pregnancy For patients in the Collabri Flex group: * Patients with depression who wants treatment cf. the psychologist scheme (Psykologordningen) or similar treatment and do not want the refferal to the psychologist preceded by other treatment, cf. the Collabri Flex model assessed by the GP * Patients that wish to continue current psychological or psychiatric treatment due to anxiety or depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported degree of anxiety | 6 months | Measured by Beck Anxiety Inventory (BAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported degree of depression | 6 months | Measured by Beck Depression Inventory (BDI-II) |
| Self-reported pychological stress | 6 months | Measured by the Symptom Checklist SCL-90-R |
| Self-reported functional impairment | 6 months | Measured by Sheehan Disability Scale (SDS) |
| Self-reported quality of life/well-being | 6 months | Measured by WHO-5 |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORLene Falgaard Eplov, MD,PhD
Research Unit, Mental Health Center Copenhagen
Outcome results
None listed