Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.

BACKGROUND: Bipolar 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. METHODS: In 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. DISCUSSION: The 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 REGISTRATION: USA: ClinicalTrials.gov NCT02506322 . Registered on 19 December 2014; Germany: German Clinical Trials Register DRKS00006013 . Registered on21 May 2015.

Efficacy of cognitive-behavioral group therapy in patients at risk for serious mental illness presenting with subthreshold bipolar symptoms: Results from a prespecified interim analysis of a multicenter, randomized, controlled study.

OBJECTIVE: Most patients with bipolar disorders (BD) exhibit prodromal symptoms before a first (hypo)manic episode. Patients with clinically significant symptoms fulfilling at-risk criteria for serious mental illness (SMI) require effective and safe treatment. Cognitive-behavioral psychotherapy (CBT) has shown promising results in early stages of BD and in patients at high risk for psychosis. We aimed to investigate whether group CBT can improve symptoms and functional deficits in young patients at risk for SMI presenting with subthreshold bipolar symptoms. METHOD: In a multicenter, randomized, controlled trial, patients at clinical risk for SMI presenting with subthreshold bipolar symptoms aged 15-30 years were randomized to 14 weeks of at-risk for BD-specific group CBT or unstructured group meetings. Primary efficacy endpoints were differences in affective symptomatology and psychosocial functioning at 14 weeks. At-risk status was defined as a combination of subthreshold bipolar symptomatology, reduction of psychosocial functioning and a family history for (schizo)affective disorders. A prespecified interim analysis was conducted at 75% of the targeted sample. RESULTS: Of 128 screened participants, 75 were randomized to group CBT (n = 38, completers = 65.8%) vs unstructured group meetings (n = 37, completers = 78.4%). Affective symptomatology and psychosocial functioning improved significantly at week 14 (P < .001) and during 6 months (P < .001) in both groups, without significant between-group differences. Findings are limited by the interim character of the analysis, the use of not fully validated early detection interviews, a newly adapted intervention manual, and the substantial drop-outs. CONCLUSIONS: Results suggest that young patients at-risk for SMI presenting with subthreshold bipolar symptoms benefit from early group sessions. The degree of specificity and psychotherapeutic interaction needed requires clarification.

Improving functional outcome in bipolar disorder: A pilot study on metacognitive training.

BACKGROUND: Effective group psychological interventions in bipolar disorder are rare. In this study, we present "metacognitive training (MCT) for bipolar disorder"-an adaption of a group intervention that has proven effective in other severe psychiatric disorders. MCT is a structured, interactive approach that addresses cognitive biases, social cognition, and self-esteem. In this pilot study, we investigated psychosocial functioning as primary outcome measure, as well as the feasibility of MCT and its acceptance among bipolar patients. METHODS: Thirty-four outpatients with bipolar disorder were recruited. Inclusion criteria were euthymia and psychosocial functioning with a score >11 assessed by the Functional Assessment Short Test. The subjects received eight weekly MCT sessions. Before and after the intervention, psychosocial functioning, quality of life (QoL), and patient views were assessed. RESULTS: Patients improved significantly in global psychosocial functioning, with a large effect size from baseline to post-treatment. Over the intervention period, patient QoL improved significantly in terms of their physical health, however not for other QoL subdomains. Treatment adherence was 80%, and patients' appraisal of the training was positive. LIMITATIONS: As this study lacks a control group, it is not possible to ascertain whether the positive treatment effects are attributable to MCT. Additionally, it is unclear whether gains in psychosocial functioning would have been maintained long term. CONCLUSIONS: This pilot trial conclusively shows that MCT is feasible and provides preliminary evidence for both the acceptance and efficacy of MCT. Further studies with larger samples and control condition will be necessary to build on these findings.