Clinical trial NCT04229875: The CAG Bipolar the CAG Bipolar RCT
Official title: Effects of Specialized Treatment for Bipolar Disorder - the CAG Bipolar RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Maria Faurholt-Jepsen, MD, DMSc
name: The Mental Health Services in the Capital Region of Denmark
First posted: 2020-01-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk of psychiatric hospitalization
timeFrame: During the entire study period of 12 months pr participant
measure: Cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register
timeFrame: During the entire study period of 12 months pr participant
Secondary outcomes:
measure: Quality of life according to WHO Quality of Life-BREF (WHOQoL)
timeFrame: Baseline, 6 months and 12 months
measure: Perceived stress according to Cohen's Perceived stress scale
timeFrame: Baseline, 6 months and 12 months
measure: Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
timeFrame: Baseline, 6 months and 12 months
measure: Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: 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
timeFrame: During the entire study period of 12 months per participant
measure: Clinicians' satisfaction with their work at start and end of the RCT
timeFrame: Baseline and 12 months
measure: Patient-reported depressive symptoms according to the major depressive Inventory (MDI)
timeFrame: Baseline, 6 months and 12 months
measure: Patient-reported manic symptoms according to the Altman Self-rating Scale for Mania (ASRM)
timeFrame: Baseline, 6 months and 12 months
measure: Proportion of patients starting group-based psychoeducation
timeFrame: During the entire study period of 12 months per centre
Other outcomes:
measure: Long-term register-based outcome measures: risk of hospitalization
timeFrame: 3, 5 and 10 years follow-up
measure: Long-term register-based outcome measures: duration of hospitalization
timeFrame: 3, 5 and 10 years follow-up
measure: Long-term register-based outcome measures: prescribed medication
timeFrame: 3, 5 and 10 years follow-up
measure: Long-term register-based outcome measures: psychosocial measures (sickdays)
timeFrame: 3, 5 and 10 years follow-up
measure: Long-term register-based outcome measures: somatic comorbidity
timeFrame: 3, 5 and 10 years follow-up
measure: Long-term register-based outcome measures: rate of suicide and death
timeFrame: 3, 5 and 10 years follow-up
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Center Copenhagen
Study officials:
References:
citation: 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.