Abstract
BackgroundBipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant personal and social costs as a consequence of their illness. Despite this, to date, there is limited (controlled) evidence regarding the effectiveness of psychotherapy during the critical stages of the disorder (e.g., early onset). Some preliminary studies suggest that targeted, tailored early interventions in particular may improve disease prognosis. The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.MethodsIn this multicenter randomized controlled trial (RCT), 300 patients with bipolar disorder are randomized to one of two group psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or Emotion-Focused Supportive Therapy (EFST; active control group). Each therapy comprises of a total of 48-h sessions (delivered once a month) over a period of 4 months. Assessments take place at baseline (t1); 6 months follow-up, i.e., post-intervention (t2); 12 months follow-up (t3); and 18 months follow-up (t4), whereby 18 months follow-up is the primary time point of interest.DiscussionThe goal of this study is to test the effects of an innovative, specific group therapy relative to an active control condition in terms of rates of relapse, global functioning, and neuropsychological functioning. Pending the outcomes of the trial, it will be possible to establish a firm evidence base for accessible group psychotherapy adjuvant to routine psychiatric care for individuals with bipolar disorder.Trial registrationUSA: ClinicalTrials.gov NCT02506322. Registered on 19 December 2014; Germany: German Clinical Trials Register DRKS00006013. Registered on21 May 2015
Highlights
Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse
We wanted to test three groups of hypotheses regarding the addition of a specific, innovative psychotherapy (SECT) to psychiatric care in young bipolar patients in the early stage of their disease
Our outcomes are defined as follows: primary—(1) reduced rate of relapse; secondary—(2) reduced missed days at work/ school, days spent in hospitals, and health costs; improved medical treatment compliance and social functioning; (3) normalized neurobiological functioning; pretreatment neural alterations in neurobiological systems will predict post-treatment outcome of Specific Emotional-Cognitive Therapy (SECT), with the greatest improvement in SECT for patients with the most pronounced neural alterations prior to treatment
Summary
Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. The onset age of bipolar disorders is typically during late adolescence and early adulthood This is a very sensitive phase for educational, professional, and social development. This is a critical time in the developmental lifespan characterized by the establishment of one’s personality and often experimentation with oppositional attitudes, chaotic social and sleeping rhythms, and drug use In bipolar disorder, such activities may challenge compliance and increase the risk of relapse. A staging model implying that bipolar disorder can be classified as a chronic, recurrent disease has been proposed and entails the following stages: asymptomatic (stage 0), prodromal with a low to high-risk profile (stage 1a/1b), onset (stage 2), early stage with occasional relapses and long interepisode remission periods (stage 3a/b), multiple relapses (3c), and refractory therapeutic course with persistent symptoms and functional deficits (stage 4 [4];)
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