Project Collabri for Treatment of Anxiety

ID: NCT02678624

Status: Active, not recruiting

Phase: N/A

Start Date: November 01, 2014

First Submitted: February 07, 2016

Last Updated: December 05, 2017

Results: N/A

Organization: Mental Health Centre Copenhagen

Sponsors & Collaborators: Mental Health Centre Copenhagen

Location: Denmark

Conditions: Generalized Anxiety, Social Phobia, Panic Disorder

Contact

Save

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Details
No Results Posted

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.

Condition or disease	Intervention/treatment	Phase
Generalized Anxiety Panic Disorder Social Phobia	Other: Treatment according to the Collabri model Other Names	N/A

Tracking Information

First Submitted Date	February 07, 2016
Last Update Posted Date	December 05, 2017
Start Date	November 01, 2014
Anticipated Completion Date	March 01, 2018
Primary Completion Date	July 01, 2017
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

Degree of anxiety measured by the Beck Anxiety Inventory (BAI) [Time Frame: At 6 months follow up after baseline]
The measure is self-reported

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Degree of depression measured by the Beck Depression Inventory (BDI) [Time Frame: At 6 months follow up after baseline]
The measure is self-reported
Psychological stress measured with the Symptom Checklist (SCL-92) [Time Frame: At 6 months follow up after baseline]
The measure is self-reported
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version) [Time Frame: At 6 months follow up after baseline]
The measure is obtained through a semi-structured interview

Original Secondary Outcome Measures

Not Available

Study Design

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
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.
Study Type	Interventional
Study Phase	N/A
Estimated Enrollment	1092
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Single
Primary Purpose	Treatment
Conditions	Generalized Anxiety Panic Disorder Social Phobia
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Other: Treatment according to the Collabri model 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. Other Names
Study Groups/Cohorts	Treatment according to the Collabri model 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 Treatment as usual 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.
Study Arms	Experimental Treatment according to the Collabri model 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 Other : Treatment according to the Collabri model 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.

Arm	Intervention/Treatment
Experimental Treatment according to the Collabri model 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	Other : Treatment according to the Collabri model 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.

Arm

Intervention/Treatment

Experimental Treatment according to the Collabri model

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

Other : Treatment according to the Collabri model

Recruitment Information

Recruitment Status:	Active, not recruiting
Enrollment	1092
Completion Date	March 01, 2018
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
Gender	All
Age	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Denmark

Administrative Information

NCT Number:	NCT02678624
Other Study ID Numbers	H-3-2013-203-A
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	Mental Health Centre Copenhagen
Collaborators	Not Available
Investigators	Principal Investigator Lene F Eplov, MD PhD Mental Health Center Copenhagen