The CAG Bipolar the CAG Bipolar RCT

March 15, 2023 updated by: Lars Vedel Kessing, Mental Health Services in the Capital Region, Denmark

Effects of Specialized Treatment for Bipolar Disorder - the CAG Bipolar RCT

The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. Traditionally, psychiatry has been sparsely subspecialized in Denmark as well as internationally during the last four decades leaving patients in generalized psychiatric settings. At the same time, demands to clinical skills, research and education have increased, and IT solutions have emerged as a possible way to optimize treatment.

Effects of organizational changes and digital health interventions are rarely investigated scientifically in health care services. This is a randomized controlled trial conducted in the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region.

The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients). Findings from the study will have great impact on future organization and optimization of treatment within psychiatry in Denmark as well as internationally.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with a main diagnosis of bipolar disorder in the five largest psychiatric centers in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hillerød, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup) will be asked for participation

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAG Bipolar
  1. Patients will be treated in a localized CAG Bipolar clinic within each psychiatric centre increasing the number of bipolar patients for each clinician
  2. All clinicians will get certified in diagnosing and treating bipolar disorder by joining an educational course and ongoing courses continuously
  3. Treatment will include a group-based psychoeducation program
  4. Coordinated targets to improve quality of life of patients by increasing concordance between clinicians, patients and relatives on well-defined treatment goals
  5. Continued ongoing supervision of patient cases in CAG Bipolar staff by the Copenhagen Affective Disorder Clinic
  6. Three-month bidirectional exchange of two clinical staff members between the Copenhagen Affective Disorder Clinic and each CAG Bipolar clinic
  7. Recovery mentors
Other: CAG Bipolar
See description of CAG Bipolar
No Intervention: Control group
Standard treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Risk of psychiatric hospitalization
Time Frame: During the entire study period of 12 months pr participant
Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status
During the entire study period of 12 months pr participant
Cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register
Time Frame: During the entire study period of 12 months pr participant
Data on cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status
During the entire study period of 12 months pr participant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life according to WHO Quality of Life-BREF (WHOQoL)
Time Frame: Baseline, 6 months and 12 months
Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated
Baseline, 6 months and 12 months
Perceived stress according to Cohen's Perceived stress scale
Time Frame: Baseline, 6 months and 12 months
Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.
Baseline, 6 months and 12 months
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
Time Frame: Baseline, 6 months and 12 months
Patient evaluated. Higher scores indicate higher satisfaction with treatment.
Baseline, 6 months and 12 months
Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire
Time Frame: Baseline, 6 months and 12 months
Patient evaluated. Higher scores indicate higher satisfaction with treatment.
Baseline, 6 months and 12 months
Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine
Time Frame: During the entire study period of 12 months per participant
Data collected from electronic patient records.
During the entire study period of 12 months per participant
Clinicians' satisfaction with their work at start and end of the RCT
Time Frame: Baseline and 12 months
Clinician evaluated using the Medical Personnel Job Satisfaction Questionnaire
Baseline and 12 months
Patient-reported depressive symptoms according to the major depressive Inventory (MDI)
Time Frame: Baseline, 6 months and 12 months
Patient-evaluated. Higher scores indicate higher level of depressive symptoms.
Baseline, 6 months and 12 months
Patient-reported manic symptoms according to the Altman Self-rating Scale for Mania (ASRM)
Time Frame: Baseline, 6 months and 12 months
Patient-evaluated. Higher scores indicate higher level of manic symptoms.
Baseline, 6 months and 12 months
Proportion of patients starting group-based psychoeducation
Time Frame: During the entire study period of 12 months per centre
Proportion of patients in clinics starting in group-based psychoeducation
During the entire study period of 12 months per centre

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long-term register-based outcome measures: risk of hospitalization
Time Frame: 3, 5 and 10 years follow-up
Danish registry data with data available on number of longt-term hospitalizations
3, 5 and 10 years follow-up
Long-term register-based outcome measures: duration of hospitalization
Time Frame: 3, 5 and 10 years follow-up
Danish registry data with data available on number of longt-term days during hospitalizations
3, 5 and 10 years follow-up
Long-term register-based outcome measures: prescribed medication
Time Frame: 3, 5 and 10 years follow-up
Danish registry data with data available on the medicine prescribed
3, 5 and 10 years follow-up
Long-term register-based outcome measures: psychosocial measures (sickdays)
Time Frame: 3, 5 and 10 years follow-up
Danish registry data with data available on number of days away form work
3, 5 and 10 years follow-up
Long-term register-based outcome measures: somatic comorbidity
Time Frame: 3, 5 and 10 years follow-up
Danish registry data with data available on somatic diagnoses
3, 5 and 10 years follow-up
Long-term register-based outcome measures: rate of suicide and death
Time Frame: 3, 5 and 10 years follow-up
Danish registry data with the data available
3, 5 and 10 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mental Health Services in the Capital Region, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maria Faurholt-Jepsen, MD, DMSc
The Mental Health Services in the Capital Region of Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-19067248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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