The CAG Bipolar the CAG Bipolar RCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2025-01-13

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).

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

CAG Bipolar

Intervention Type OTHER

See description of CAG Bipolar

Control group

Standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CAG Bipolar

See description of CAG Bipolar

Intervention Type OTHER

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