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Project Collabri for Treatment of Anxiety

Primary Purpose

Generalized Anxiety, Social Phobia, Panic Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Treatment according to the Collabri model
Sponsored by
Mental Health Centre Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Centre Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment according to the Collabri model

Treatment as usual

Arm Description

Participants in this group will recive treatment according to the Collabri model which is a Danish model for collaborative care between primary and secondary care for depression, social phobia, generalized anxiety and panic disorder

Control group. Participants in this group will recive treatment as usual. This means that participants will recive treatment corresponding to what their GP normally would offer as treatment. E.g. this could be refferal to a psychologist or psychiatrist and/or medicine.

Outcomes

Primary Outcome Measures

Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
The measure is self-reported

Secondary Outcome Measures

Degree of depression measured by the Beck Depression Inventory (BDI)
The measure is self-reported
Psychological stress measured with the Symptom Checklist (SCL-92)
The measure is self-reported
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
The measure is obtained through a semi-structured interview

Full Information

First Posted
February 7, 2016
Last Updated
September 10, 2021
Sponsor
Mental Health Centre Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02678624
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety, Social Phobia, Panic Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment according to the Collabri model
Arm Type
Experimental
Arm Description
Participants in this group will recive treatment according to the Collabri model which is a Danish model for collaborative care between primary and secondary care for depression, social phobia, generalized anxiety and panic disorder
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Control group. Participants in this group will recive treatment as usual. This means that participants will recive treatment corresponding to what their GP normally would offer as treatment. E.g. this could be refferal to a psychologist or psychiatrist and/or medicine.
Intervention Type
Other
Intervention Name(s)
Treatment according to the Collabri model
Intervention Description
The Collabri Model is a complex intervention and consists of a number of treatment modalities. The Collabri Model includes the following elements: A multi-professional approach to treatment including a care manager, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan. It further integrates: Recruitment of staff with psychiatric experience, training of general practitioner and care manager, use of instruments for detection and follow-up, education and treatment of the patient, supervision from a psychiatric specialist, guided self-help, patient- and relative involvement and a stepped care approach to treatment where treatment is always commenced on the least invasive and least resource-demanding level.
Primary Outcome Measure Information:
Title
Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Secondary Outcome Measure Information:
Title
Degree of depression measured by the Beck Depression Inventory (BDI)
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Psychological stress measured with the Symptom Checklist (SCL-92)
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
Description
The measure is obtained through a semi-structured interview
Time Frame
At 6 months follow up after baseline
Other Pre-specified Outcome Measures:
Title
Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Degree of depression measured by the Beck Depression Inventory (BDI)
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Psychological stress measured with the Symptom Checklist (SCL-92)
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
Description
The measure is obtained through a semi-structured interview
Time Frame
At 15 months follow up after baseline
Title
Quality of life measured with the WHO-5 scale
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Quality of life measured with the WHO-5 scale
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Personal and social performance measured with the Personal and Social Performance scale (PSP)
Description
The measure is obtained through a semi-structured interview
Time Frame
At 6 months follow up after baseline
Title
Personal and social performance measured with the Personal and Social Performance scale (PSP)
Description
The measure is obtained through a semi-structured interview
Time Frame
At 15 months follow up after baseline
Title
Side effects measured by the PRISE questionnaire
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Side effects measured by the PRISE questionnaire
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Health-related quality of life measured with the EQ-5D
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Health-related quality of life measured with the EQ-5D
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Functional impairment measured with Sheehan Disability Scale (SDS)
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Functional impairment measured with Sheehan Disability Scale (SDS)
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Sick leave
Description
The measure is obtained from the Danish DREAM database
Time Frame
At 6 months follow up after baseline
Title
Sick leave
Description
The measure is obtained from the Danish DREAM database
Time Frame
At 15 months follow up after baseline
Title
Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)
Description
The measure is self-reported
Time Frame
At 6 months follow up after baseline
Title
Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)
Description
The measure is self-reported
Time Frame
At 15 months follow up after baseline
Title
Apathia
Description
The measure is obtained through a semi-structured interview
Time Frame
At 6 months follow up after baseline
Title
Apathia
Description
The measure is obtained through a semi-structured interview
Time Frame
At 15 months follow up after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene F Eplov, MD PhD
Organizational Affiliation
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
No
Citations:
PubMed Identifier
33203365
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.
Results Reference
derived
PubMed Identifier
28814317
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.
Results Reference
derived

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Project Collabri for Treatment of Anxiety

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