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

Post Traumatic Stress Disorder Clinical Trial

Official title:

Project Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Anxiety and Depression in General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113175
• Other study ID #: Collabri Flex - Anxiety
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: March 29, 2021

Study information

• Verified date: February 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Generalized Anxiety Disorder
• Obsessive-Compulsive Disorder
• Panic Disorder
• Phobia, Social
• Post Traumatic Stress Disorder
• Social Phobia
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Collaborative 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
• Consultations-Liaison
Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

Locations

Country	Name	City	State
Denmark	Mental Health Centre Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sick leave	Obtained from the DREAM database	6 months
Other	Sick leave	Obtained from the DREAM database	18 months
Other	Self-reported self-efficacy	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	6 months
Other	Self-reported self-efficacy	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	18 months
Other	Self-reported health-related quality of life	Measured by EQ-5D	6 months
Other	Self-reported health-related quality of life	Measured by EQ-5D	18 months
Other	Employment	Obtained from the DREAM database	6 months
Other	Employment	Obtained from the DREAM database	18 months
Other	Mental-health outpatient services	National patient register	6 months
Other	Mental-health outpatient services	National patient register	18 months
Other	Experience of support in recovery	Self-reported support in recovery (INSPIRE)	6 months
Other	Patient satisfaction	Self-reported satisfaction with treatment (CSQ-8)	6 months
Other	Self-reported degree of anxiety	Measured by Beck Anxiety Inventory (BAI)	18 months
Other	Self-reported degree of depression	Measured by Beck Depression Inventory (BDI-II)	18 months
Other	Self-reported pychological stress	Measured by the Symptom Checklist SCL-90-R	18 months
Other	Self-reported functional impairment	Measured by Sheehan Disability Scale (SDS)	18 months
Other	Self-reported quality of life/well-being	Measured by WHO-5	18 months
Primary	Self-reported degree of anxiety	Measured by Beck Anxiety Inventory (BAI)	6 months
Secondary	Self-reported degree of depression	Measured by Beck Depression Inventory (BDI-II)	6 months
Secondary	Self-reported pychological stress	Measured by the Symptom Checklist SCL-90-R	6 months
Secondary	Self-reported functional impairment	Measured by Sheehan Disability Scale (SDS)	6 months
Secondary	Self-reported quality of life/well-being	Measured by WHO-5	6 months