The CAG Bipolar the CAG Bipolar RCT

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

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).

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: CAG Bipolar

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars Vedel Kessing, Prof., MD, DMSc; Phone Number: +4538647073; Email: lars.vedel.kessing@regionh.dk
• Study Contact Backup: Name: Maria Faurholt-Jepsen, MD, DMSc; Phone Number: +4538647073; Email: maria.faurholtjepsen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Psychiatric Center Copenhagen
    • Contact: Maria Faurholt-Jepsen, MD, DMSc; Phone Number: 0045 38647073; Email: maria.faurholtjepsen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: CAG Bipolar; See description of CAG Bipolar
No Intervention: Control group; Standard treatment

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term register-based outcome measures: risk of hospitalization	Danish registry data with data available on number of longt-term hospitalizations	3, 5 and 10 years follow-up
Long-term register-based outcome measures: duration of hospitalization	Danish registry data with data available on number of longt-term days during hospitalizations	3, 5 and 10 years follow-up
Long-term register-based outcome measures: prescribed medication	Danish registry data with data available on the medicine prescribed	3, 5 and 10 years follow-up
Long-term register-based outcome measures: psychosocial measures (sickdays)	Danish registry data with data available on number of days away form work	3, 5 and 10 years follow-up
Long-term register-based outcome measures: somatic comorbidity	Danish registry data with data available on somatic diagnoses	3, 5 and 10 years follow-up
Long-term register-based outcome measures: rate of suicide and death	Danish registry data with the data available	3, 5 and 10 years follow-up

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Maria Faurholt-Jepsen, MD, DMSc; The Mental Health Services in the Capital Region of Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Anticipated): November 13, 2023
• Study Completion (Anticipated): January 13, 2025

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 11, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: H-19067248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No