Abstract
BackgroundDespite various pharmacological and psychological treatment interventions, bipolar disorders rank among the leading causes of global disease burden. Group psychoeducation has been demonstrated an effective add-on to pharmacotherapy, but it may be difficult to implement in practice depending on the clinical setting and available human resources.MethodsMulticenter, rater-blind, randomized controlled trial to investigate the efficacy of a new intervention program consisting of an initial 6-week psychoeducation protocol plus a subsequent structured daily computer-based self-charting program (ChronoRecord) over 54 weeks in remitted patients with bipolar disorders. The control condition included non-structured group sessions followed by daily computer-based self-reports (unstructured like a diary). Both groups received treatment-as-usual.ResultsOver 2 years, 41 mood episodes occurred in the experimental group (n = 39) compared to 27 in the control group (n = 34), without reaching statistical significance. Time to recurrence did not significantly differ between the experimental and control group (25% relapsed after 112 and 273 days, respectively). There were no significant group-by-time interactions in mood symptoms, quality of life, self-efficacy expectations or perceived involvement in care.ConclusionsSix weekly psychoeducational group sessions followed by daily self-monitoring via ChronoRecord for 54 weeks may not be superior to non-structured group meetings followed by unstructured self-reporting. Other psychotherapeutic interventions may be needed to optimize the treatment of patients with bipolar disorders, especially for those at later disease stages.Trial registration Retrospectively registered at German Clinical Trials Register on May 24, 2019; DRKS00017319
Highlights
Despite various pharmacological and psychological treatment interventions, bipolar disorders rank among the leading causes of global disease burden
Since a large observational study using a within-individual analysis of registry data indicates the effectiveness of short-term group programs (Joas et al 2019), these may help to expand the routine use of PE, yet there is insufficient evidence from randomized controlled trials (RCT)
The trial aimed to conduct the first RCT of PE in Germany and go beyond what has been demonstrated in the scientific literature by testing a combined nonpharmacological approach in the treatment of Bipolar disorders (BD). Study design This is a multicenter RCT in a parallel 2-group design added to TAU with standard pharmacotherapy for patients with remitted BD
Summary
Despite various pharmacological and psychological treatment interventions, bipolar disorders rank among the leading causes of global disease burden. Despite the availability of effective pharmacological treatments (National Collaborating Centre for Mental Health 2018), the long-term course of BD remains marked by frequent relapses and recurrences as well as subsyndromal symptoms (Treuer and Tohen 2010). BD are a leading cause of disability worldwide (Catala-Lopez et al 2013), are associated with a high suicide rate (Nordentoft et al 2011) and remain a major public health problem. In this context, psychoeducation (PE) manuals have been developed to empower patients to actively contribute to their treatment and thereby maintain remission and reach full recovery. Since a large observational study using a within-individual analysis of registry data indicates the effectiveness of short-term group programs (Joas et al 2019), these may help to expand the routine use of PE, yet there is insufficient evidence from randomized controlled trials (RCT)
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