The CAG Bipolar the CAG Bipolar RCT
Effects of Specialized Treatment for Bipolar Disorder - the CAG Bipolar RCT
1 other identifier
interventional
1,000
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2020
CompletedStudy Start
First participant enrolled
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2025
CompletedMarch 16, 2023
March 1, 2023
3.8 years
January 3, 2020
March 15, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Risk of psychiatric hospitalization
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
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 Outcomes (9)
Quality of life according to WHO Quality of Life-BREF (WHOQoL)
Baseline, 6 months and 12 months
Perceived stress according to Cohen's Perceived stress scale
Baseline, 6 months and 12 months
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
Baseline, 6 months and 12 months
Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire
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
During the entire study period of 12 months per participant
- +4 more secondary outcomes
Other Outcomes (6)
Long-term register-based outcome measures: risk of hospitalization
3, 5 and 10 years follow-up
Long-term register-based outcome measures: duration of hospitalization
3, 5 and 10 years follow-up
Long-term register-based outcome measures: prescribed medication
3, 5 and 10 years follow-up
- +3 more other outcomes
Study Arms (2)
CAG Bipolar
EXPERIMENTAL1. 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
Control group
NO INTERVENTIONStandard treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychiatric Center Copenhagen
Copenhagen, 2100, Denmark
Related Publications (1)
Kessing LV, Kyster NB, Bondo-Kozuch P, Christensen EM, Vejstrup B, Smidt B, Jorgensen AB, Rosenberg R, Mardosas D, Rasmussen LB, Vinberg M, Hageman I, Faurholt-Jepsen M; CAG Bipolar Study group. Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial. BMJ Open. 2021 Oct 13;11(10):e048821. doi: 10.1136/bmjopen-2021-048821.
PMID: 34645661DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof., Principal Investigator
Study Record Dates
First Submitted
January 3, 2020
First Posted
January 18, 2020
Study Start
January 13, 2020
Primary Completion
November 13, 2023
Study Completion
January 13, 2025
Last Updated
March 16, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share