The CAG Bipolar the CAG Bipolar RCT

Mental Health Services in the Capital Region, Denmark

Status: Enrolling

Conditions: Bipolar Disorder

Treatments: Other: CAG Bipolar

Study type: Interventional

Funder types: Other

Identifiers

NCT04229875

H-19067248

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

CAG Bipolar

Experimental group

Description:

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

Treatment:

Other: CAG Bipolar

Control group

No Intervention group

Description:

Standard treatment