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

Abstract

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.

Preventive psychiatry: a blueprint for improving the mental health of young people

“…Individual psychotherapy (no efficacy on affective symptoms) 107 *…”

“…Interventional research is in its infan­cy. Two randomized controlled trials con­duct­ed in young people presenting with ge­netic risk for (schizo)affective disorder and attenuated affective symptoms suggested a potential beneficial effect of family‐focused and cognitive behavioural therapy on time to recovery from attenuated symptoms 106 , but no efficacy in terms of reducing the severity of affective symptoms 107 or preventing the onset of bipolar disorder 106 .…”

Early detection of bipolar disorders and treatment recommendations for help-seeking adolescents and young adults: Findings of the Early Detection and Intervention Center Dresden

“…Recently published first data from early tailored cognitive behavioral group therapy applied to at-risk subjects show a reduction of affective symptoms and better psychosocial functioning after up to six month. However, there was no significant difference compared to the unstructured control group treatment (Leopold et al 2020 ).…”

Brief Research Report: A Pilot Study of Cognitive Behavioral Regulation Therapy (CBT-REG) for Young People at High Risk of Early Transition to Bipolar Disorders

“…Reviews highlight that these interventions appear to target key issues in BD (such as mood instability) and that family psychoeducation (PED) may be helpful in those who are already receiving treatment (8,9). However, outcomes of published clinical trials are inconsistent, with lack of evidence of additional benefits compared with support or control interventions (10,11). Given these findings, and awareness that formal family PED may be unfeasible or unwanted by some adolescents and young adults, we decided to pilot an intervention that could be delivered to individuals, with an option of family sessions if appropriate.…”