The CAG Bipolar the CAG Bipolar RCT

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Other: CAG Bipolar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAG Bipolar<br>Patients will be treated in a localized CAG Bipolar clinic within each psychiatric centre increasing the number of bipolar patients for each clinician All clinicians will get certified in diagnosing and treating bipolar disorder by joining an educational course and ongoing courses continuously Treatment will include a group-based psychoeducation program Coordinated targets to improve quality of life of patients by increasing concordance between clinicians, patients and relatives on well-defined treatment goals Continued ongoing supervision of patient cases in CAG Bipolar staff by the Copenhagen Affective Disorder Clinic Three-month bidirectional exchange of two clinical staff members between the Copenhagen Affective Disorder Clinic and each CAG Bipolar clinic Recovery mentors | Other: CAG Bipolar<br>* See description of CAG Bipolar<br>|
| No Intervention: Control group<br>Standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life according to WHO Quality of Life-BREF (WHOQoL) | 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 | 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 | 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 | 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 | 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 | Clinician evaluated using the Medical Personnel Job Satisfaction Questionnaire | Baseline and 12 months | 
| Patient-reported depressive symptoms according to the major depressive Inventory (MDI) | 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) | Patient-evaluated. Higher scores indicate higher level of manic symptoms. | Baseline, 6 months and 12 months | 
| Proportion of patients starting group-based psychoeducation | Proportion of patients in clinics starting in group-based psychoeducation | During the entire study period of 12 months per centre |