A cognitive-behavioral treatment for suicide prevention among adults with schizophrenia spectrum disorders in community mental health: Study protocol for a pilot feasibility and acceptability randomized clinical trial.

ABSTRACT

BACKGROUND: Suicide is among the leading causes of death for adults with schizophrenia spectrum disorders (SSDs), and there is a paucity of evidence-based suicide prevention-focused interventions tailored for this vulnerable population. Cognitive-Behavioral Suicide Prevention for psychosis (CBSPp) is a promising intervention developed in the UK that required modifications for delivery in community mental health (CMH) settings in the United States of American. This pilot trial evaluates the feasibility, acceptability, and preliminary effectiveness of our modified CBSPp intervention in comparison to services as usual (SAU) within a CMH setting in a Midwestern state of the USA. METHODS: This is a single-site randomized pilot trial with a planned enrollment of 60 adults meeting criteria for both SSD and SI/A. Eligible participants will be randomized 11 to either 10 sessions of CBSPp or SAU. Clinical and cognitive assessments will be conducted within a 4-waive design at baseline (prior to randomization and treatment) and approximately 1 month (mid-treatment), 3 months (post-treatment), and 5 months (follow-up) after baseline assessment. Qualitative interviews will also be conducted at post-treatment. The primary objective is to determine whether CBSPp is feasible and acceptable, involving examinations of recruitment rate, treatment engagement and adherence, retention and completion rates, and experiences in the CBSPp treatment and overall study. The secondary objective is to preliminarily evaluate whether modified CBSPp is associated with reductions in clinical (suicide ideation, suicide attempt, symptoms of psychosis, depression, and emergency/hospital service, hopelessness, defeat, and entrapment) and cognitive (information processing biases, appraisals, and schemas) outcomes in comparison to SAU from baseline to post-treatment assessment. DISCUSSION: This randomized pilot trial will provide clinically relevant information about whether CBSPp can improve SI/A, depression, and psychosis among adults with SSDs. Testing this modified cognitive-behavioral suicide prevention-focused intervention has the potential for a large public health impact by increasing the intervention's utility and usability in CMH where many individuals with SSDs receive care, and ultimately working towards reductions in premature suicide death. TRIAL REGISTRATION ClinicalTrials.gov NCT#05345184. Registered on April 12, 2022.