Collabri Flex - Effect of Collaborative Care for People With Anxiety Disorders in General Practice

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.

• Collaborative care (Behavioral): Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation, medication according to a stepped care model
• Consultations-Liaison (Behavioral): Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

Primary outcomes

• Self-reported degree of anxiety [6 months]: Measured by Beck Anxiety Inventory (BAI)

Secondary outcomes

• 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

Other outcomes

• Sick leave [6 months]: Obtained from the DREAM database
• Sick leave [18 months]: Obtained from the DREAM database
• Self-reported self-efficacy [6 months]: Measured by the IPQ-R Scale (Personal control) and two subscales from the Chronic disease Selv-Efficacy Scales (SECD-32); Obtain help from Community, Family, Friends Scale and control Manage Depression Scale
• Self-reported self-efficacy [18 months]: Measured by the IPQ-R Scale (Personal control) and two subscales from the Chronic disease Selv-Efficacy Scales (SECD-32); Obtain help from Community, Family, Friends Scale and control Manage Depression Scale
• Self-reported health-related quality of life [6 months]: Measured by EQ-5D
• Self-reported health-related quality of life [18 months]: Measured by EQ-5D
• Employment [6 months]: Obtained from the DREAM database
• Employment [18 months]: Obtained from the DREAM database
• Mental-health outpatient services [6 months]: National patient register
• Mental-health outpatient services [18 months]: National patient register
• Experience of support in recovery [6 months]: Self-reported support in recovery (INSPIRE)
• Patient satisfaction [6 months]: Self-reported satisfaction with treatment (CSQ-8)
• Self-reported degree of anxiety [18 months]: Measured by Beck Anxiety Inventory (BAI)
• Self-reported degree of depression [18 months]: Measured by Beck Depression Inventory (BDI-II)
• Self-reported pychological stress [18 months]: Measured by the Symptom Checklist SCL-90-R
• Self-reported functional impairment [18 months]: Measured by Sheehan Disability Scale (SDS)
• Self-reported quality of life/well-being [18 months]: Measured by WHO-5

Sex: All, ages: 18 Years to any

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

• Results publication: Curth NK, Bjorkedal STB, Hjorthoj C, Brinck-Claussen U, Jorgensen KB, Rosendal S, Bojesen AB, Nordentoft M, Eplov LF. Collaborative Care Versus Consultation Liaison for Patients With Depression or Anxiety Disorders in General Practice in Denmark: 18-Month Follow-Up From the Collabri Flex Trials. Depress Anxiety. 2025 Jun 5;2025:2909617. doi: 10.1155/da/2909617. eCollection 2025. PMID 40510804
• Results publication: Curth NK, Hjorthoj C, Brinck-Claussen U, Jorgensen KB, Rosendal S, Bojesen AB, Nordentoft M, Eplov LF. The effects of collaborative care versus consultation liaison for anxiety disorders and depression in Denmark: two randomised controlled trials. Br J Psychiatry. 2023 Sep;223(3):430-437. doi: 10.1192/bjp.2023.77. PMID 37395101
• Results publication: Curth NK, Brinck-Claussen U, Jorgensen KB, Rosendal S, Hjorthoj C, Nordentoft M, Eplov LF. Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials). Trials. 2019 Oct 25;20(1):607. doi: 10.1186/s13063-019-3657-0. PMID 31653228

• Lene Falgaard Eplov, MD,PhD, Principal investigator, Research Unit, Mental Health Center Copenhagen