The CAG Bipolar the CAG Bipolar RCT

Overview

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 Title of Study: “Effects of Specialized Treatment for Bipolar Disorder – the CAG Bipolar RCT”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 13, 2023

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.

Interventions

  • Other: CAG Bipolar
    • See description of CAG Bipolar

Arms, Groups and Cohorts

  • Experimental: CAG Bipolar
    • 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
  • No Intervention: Control group
    • Standard treatment

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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

Secondary Measures

  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mental Health Services in the Capital Region, Denmark
  • Collaborator
    • Maria Faurholt-Jepsen, MD, DMSc
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lars Vedel Kessing, Prof., Principal Investigator – Mental Health Services in the Capital Region, Denmark
  • Overall Contact(s)
    • Lars Vedel Kessing, Prof., MD, DMSc, +4538647073, lars.vedel.kessing@regionh.dk

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