BACKGROUND: The clinical effects of smartphone-based interventions for bipolar disorder (BD) have yet to be established. OBJECTIVES: To examine the efficacy of smartphone-based interventions in BD and how the included studies reported user-engagement indicators. METHODS: We conducted a systematic search on January 24, 2022, in PubMed, Scopus, Embase, APA PsycINFO, and Web of Science. We used random-effects meta-analysis to calculate the standardized difference (Hedges' g) in pre-post change scores between smartphone intervention and control conditions. The study was pre-registered with PROSPERO (CRD42021226668). RESULTS: The literature search identified 6034 studies. Thirteen articles fulfilled the selection criteria. We included seven RCTs and performed meta-analyses comparing the pre-post change in depressive and (hypo)manic symptom severity, functioning, quality of life, and perceived stress between smartphone interventions and control conditions. There was significant heterogeneity among studies and no meta-analysis reached statistical significance. Results were also inconclusive regarding affective relapses and psychiatric readmissions. All studies reported positive user-engagement indicators. CONCLUSION: We did not find evidence to support that smartphone interventions may reduce the severity of depressive or manic symptoms in BD. The high heterogeneity of studies supports the need for expert consensus to establish ideally how studies should be designed and the use of more sensitive outcomes, such as affective relapses and psychiatric hospitalizations, as well as the quantification of mood instability. The ISBD Big Data Task Force provides preliminary recommendations to reduce the heterogeneity and achieve more valid evidence in the field.

Centre for Psychiatric Research and Education Department of Clinical Neuroscience Karolinska Institutet Stockholm Sweden

Copenhagen Affective Disorder research Center Psychiatric Center Copenhagen Copenhagen Denmark

Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

Department of Psychiatry and Behavioral Sciences UT Center of Excellence on Mood Disorders McGovern Medical School The University of Texas Health Science Center at Houston Houston TX USA

Department of Psychiatry and Behavioural Neurosciences McMaster University Hamilton ON Canada

Department of Psychiatry Dalhousie University Halifax NS Canada

Department of Psychiatry Queen's University Kingston ON Canada

Department of Psychiatry University Medical Center Groningen University of Groningen Groningen The Netherlands

Department of Psychiatry University of British Columbia Vancouver BC Canada

Department of Psychiatry University of Helsinki and Helsinki University Central Hospital Helsinki Finland

Department of Psychiatry University of Toronto Toronto ON Canada

Department of Psychiatry Western Psychiatric Institute and Clinic University of Pittsburgh School of Medicine Pittsburgh PA USA

Digital Innovation Group Bipolar and Depressive Disorders Unit Institute of Neuroscience Hospital Clinic University of Barcelona IDIBAPS CIBERSAM Barcelona Catalonia Spain

Early Psychosis Interventions and Clinical detection lab Department of Psychosis Studies Institute of Psychiatry Psychology and Neuroscience King's College London London UK

Imaging of Mood and Anxiety Related Disorders group IDIBAPS CIBERSAM Barcelona Spain

Laboratory of Molecular Psychiatry and Bipolar Disorder Program Programa de Pós Graduação em Psiquiatria e Ciências do Comportamento Centro de Pesquisa Experimental do Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande do Sul Porto Alegre Brazil

Mood Disorders Program Hospital Universitario San Vicente Fundación Medellín Colombia

Mood Disorders Psychopharmacology Unit University Health Network University of Toronto Toronto ON Canada

National Institute of Mental Health Klecany Czech Republic

Neuroscience Graduate Program McMaster University Hamilton Canada

Research Group in Psychiatry Department of Psychiatry Faculty of Medicine University of Antioquia Medellín Colombia

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