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

Primary Purpose

Panic Disorder, Generalized Anxiety Disorder, Social Phobia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Collaborative care
Consultations-Liaison
Sponsored by
Mental Health Centre Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Anxiety, Collaborative care, Consultation-liaison, General practitioner, Psychiatry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Centre Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Collabri Flex

Consultation-Liaison

Arm Description

Collaborative care

Consultations with general practitioner

Outcomes

Primary Outcome Measures

Self-reported degree of anxiety
Measured by Beck Anxiety Inventory (BAI)

Secondary Outcome Measures

Self-reported degree of depression
Measured by Beck Depression Inventory (BDI-II)
Self-reported pychological stress
Measured by the Symptom Checklist SCL-90-R
Self-reported functional impairment
Measured by Sheehan Disability Scale (SDS)
Self-reported quality of life/well-being
Measured by WHO-5

Full Information

First Posted
April 10, 2017
Last Updated
March 20, 2023
Sponsor
Mental Health Centre Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03113175
Brief Title
Collabri Flex - Effect of Collaborative Care for People With Anxiety Disorders in General Practice
Official Title
Project Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Anxiety and Depression in General Practice
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
March 29, 2021 (Actual)
Study Completion Date
March 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mental Health Centre Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Generalized Anxiety Disorder, Social Phobia, Obsessive-Compulsive Disorder, Post Traumatic Stress Disorder, Agoraphobia
Keywords
Anxiety, Collaborative care, Consultation-liaison, General practitioner, Psychiatry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collabri Flex
Arm Type
Experimental
Arm Description
Collaborative care
Arm Title
Consultation-Liaison
Arm Type
Experimental
Arm Description
Consultations with general practitioner
Intervention Type
Behavioral
Intervention Name(s)
Collaborative care
Intervention Description
Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation, medication according to a stepped care model
Intervention Type
Behavioral
Intervention Name(s)
Consultations-Liaison
Intervention Description
Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).
Primary Outcome Measure Information:
Title
Self-reported degree of anxiety
Description
Measured by Beck Anxiety Inventory (BAI)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self-reported degree of depression
Description
Measured by Beck Depression Inventory (BDI-II)
Time Frame
6 months
Title
Self-reported pychological stress
Description
Measured by the Symptom Checklist SCL-90-R
Time Frame
6 months
Title
Self-reported functional impairment
Description
Measured by Sheehan Disability Scale (SDS)
Time Frame
6 months
Title
Self-reported quality of life/well-being
Description
Measured by WHO-5
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Sick leave
Description
Obtained from the DREAM database
Time Frame
6 months
Title
Sick leave
Description
Obtained from the DREAM database
Time Frame
18 months
Title
Self-reported self-efficacy
Description
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
Time Frame
6 months
Title
Self-reported self-efficacy
Description
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
Time Frame
18 months
Title
Self-reported health-related quality of life
Description
Measured by EQ-5D
Time Frame
6 months
Title
Self-reported health-related quality of life
Description
Measured by EQ-5D
Time Frame
18 months
Title
Employment
Description
Obtained from the DREAM database
Time Frame
6 months
Title
Employment
Description
Obtained from the DREAM database
Time Frame
18 months
Title
Mental-health outpatient services
Description
National patient register
Time Frame
6 months
Title
Mental-health outpatient services
Description
National patient register
Time Frame
18 months
Title
Experience of support in recovery
Description
Self-reported support in recovery (INSPIRE)
Time Frame
6 months
Title
Patient satisfaction
Description
Self-reported satisfaction with treatment (CSQ-8)
Time Frame
6 months
Title
Self-reported degree of anxiety
Description
Measured by Beck Anxiety Inventory (BAI)
Time Frame
18 months
Title
Self-reported degree of depression
Description
Measured by Beck Depression Inventory (BDI-II)
Time Frame
18 months
Title
Self-reported pychological stress
Description
Measured by the Symptom Checklist SCL-90-R
Time Frame
18 months
Title
Self-reported functional impairment
Description
Measured by Sheehan Disability Scale (SDS)
Time Frame
18 months
Title
Self-reported quality of life/well-being
Description
Measured by WHO-5
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Falgaard Eplov, MD,PhD
Organizational Affiliation
Research Unit, Mental Health Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Centre Copenhagen
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31653228
Citation
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.
Results Reference
derived

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

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