Narrative enhancement and cognitive therapy for self-stigma among youth with bipolar disorder or multiple mental health conditions: protocol for a pilot randomised basket trial.
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INTRODUCTION: Self-stigma occurs when individuals internalise negative stereotypes about their mental health conditions. Self-stigma is common among those with serious mental illnesses, including youth, and is considered a major barrier to recovery through its impact on hope, self-esteem and self-identity. This patient-oriented protocol aims to assess the feasibility of conducting a future full-scale randomised controlled trial (RCT) of a youth-oriented adaptation of narrative enhancement and cognitive therapy for self-stigma among youth (NECT-Y). METHODS AND ANALYSIS: This is a two-site, two-arm pilot basket RCT with 1:1 randomisation to NECT-Y or treatment as usual (TAU). Participants are youth, ages 16-29 diagnosed with bipolar disorder, any subtype (Basket 1) or with any two or more mental health conditions (Basket 2). After informed consent, we will conduct baseline assessments and randomisation, then either a 14-week NECT-Y group intervention or TAU. Diagnostic interviews will be used to confirm diagnosis at baseline. A range of self-report questionnaires will be administered at baseline, post-treatment and 3 month follow-up. The primary outcome is feasibility as indicated by the achievement of recruitment goals, retention and adherence, intervention fidelity and the absence of serious adverse events. Secondary outcomes include acceptability and the intervention's impact on self-stigma, wellness, symptomatology, treatment-seeking attitudes and other related constructs. A youth advisory group is informing all stages of the study process. ETHICS AND DISSEMINATION: The Research Ethics Board for Centre for Addiction and Mental Health (#062/2024) has approved this study protocol. Ethics is also approved at London Health Sciences Centre (Western Health Sciences Research Ethics Board (HSREB) #125812). Results will be published in international peer-reviewed journals and presented at relevant conferences. Summaries will be provided to the funders of the study, as well as to lay audiences, including study participants. TRIAL REGISTRATION NUMBER: NCT06672562.
