Generalized AnxietyNCT02678624
Project Collabri for Treatment of Anxiety
A study testing Treatment according to the Collabri model in people with Generalized Anxiety and Social Phobia, run by Amager Hospital at 1 site in Denmark.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Generalized Anxiety, Social Phobia, Panic Disorder
- What is being tested?
- Treatment according to the Collabri model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project Collabri. The Effects of a Danish Model of Collaborative Care for People With Anxiety in General Practice
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)
Read the 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.
- Conditions
- Generalized Anxiety, Social Phobia, Panic Disorder
- Being tested
- Treatment according to the Collabri model
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment according to the Collabri modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment according to the Collabri model | Experimental | 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 Receives: Other: Treatment according to the Collabri model |
| Treatment as usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
The measure is self-reported
Measured: At 6 months follow up after baseline
Secondary outcomes (3)
Degree of depression measured by the Beck Depression Inventory (BDI)
The measure is self-reported
Measured: At 6 months follow up after baseline
Psychological stress measured with the Symptom Checklist (SCL-92)
The measure is self-reported
Measured: At 6 months follow up after baseline
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
The measure is obtained through a semi-structured interview
Measured: At 6 months follow up after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startNov 2014
- Primary completionJul 2017
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Falgaard Eplov, Amager Hospital
- Investigators
- Lene F Eplov, MD PhD, Principal investigator, Mental Health Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678624
- Sponsor's protocol ID
- H-3-2013-203-A
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2016
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33203365Curth 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.
PubMed 28814317
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Collabri. The Effects of a Danish Model of Collaborative Care for People With Anxiety in General Practice
- ClinicalTrials.gov ID
- NCT02678624
- Acronym / sponsor ID
- H-3-2013-203-A
- Conditions
- Generalized Anxiety, Social Phobia, Panic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment according to the Collabri model | Experimental | Other: Treatment according to the Collabri modelParticipants 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment according to the Collabri modelThe 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 | Treatment according to the Collabri model |
Primary outcome
Degree of anxiety measured by the Beck Anxiety Inventory (BAI)
Time frame: At 6 months follow up after baseline
The measure is self-reported
3 secondary outcomes
Degree of depression measured by the Beck Depression Inventory (BDI)
Time frame: At 6 months follow up after baseline
Psychological stress measured with the Symptom Checklist (SCL-92)
Time frame: At 6 months follow up after baseline
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)
Time frame: At 6 months follow up after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 33203365Curth 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.
- Derived from this study: PubMed 28814317Curth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene F Eplov, MD PhD principal investigator
Mental Health Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment according to the Collabri model in people with Generalized Anxiety and Social Phobia, run by Amager Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of anxiety measured by the Beck Anxiety Inventory (BAI) (time frame: At 6 months follow up after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.