NCT03198364

Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI

Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI Accessing Community Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Schizophrenia and bipolar disorder are associated with high risk for suicide, yet there are few brief interventions that directly target suicide prevention in this large population. The goal of this intervention development study is to evaluate the feasibility, acceptability, and preliminary effectiveness of a brief intervention called SafeTy and Recovery Therapy (START) that is augmented with content delivered on mobile devices outside of the clinic setting. The intervention will evaluated in a community urgent care center context as people initiate outpatient care, and, if effective, could be deployed in a wide network of such centers.

Detailed description

This intervention development research project evaluates the feasibility, acceptability, and preliminary impact of a brief cognitive behavioral intervention, tailored to SMI, that is delivered during the gap period between urgent care evaluation and follow-up outpatient care. SafeTy and Recovery Therapy (START) is a 4-session cognitive behavioral intervention augmented by mobile technology, which delivers automated and personalized reinforcement of adaptive coping behavior outside of the clinic setting. START builds from collaborative development alongside a community psychiatric service organization, and our preliminary data in the SMI population that supports the feasibility, acceptability, and impact of brief, mobile augmented cognitive behavioral intervention. In a 3-year developmental study, our deployment focused approach will first refine intervention procedures, safety and care continuity protocols, and fit with the deployment setting with a series of collaborative contacts with community providers, project staff, advisors, and patient advocates. We will next conduct a pilot randomized controlled trial with 70 patients diagnosed with either bipolar disorder or schizophrenia rapidly referred by community triage providers to receive START in the walk-in clinic setting. Patients are enrolled who have SMI diagnoses and current active suicidal ideation and/or a suicide attempt in the prior 3 months. Participants are randomized to one of two active conditions: START + Mobile augmentation or START alone. We will evaluate feasibility, acceptability, and enhancement of rates of outpatient treatment engagement and crisis service use in comparison to the sample population. We will also examine pragmatic mechanisms, which include outpatient treatment engagement and coping self-efficacy, on change in suicidal ideation severity and crisis service use along with the preliminary impact of mobile augmentation.

Conditions

• Schizophrenia
• Bipolar Disorder
• Suicide and Self-harm

Interventions

Type	Name	Description
BEHAVIORAL	Safety and Recovery Therapy	4 session individualized psychoeducation tailored to people with bipolar disorder or schizophrenia targeting coping skills for suicidal thoughts and their determinants.
BEHAVIORAL	Mobile Augmentation	Though a smartphone device, participants receive 12 weeks of personalized prompts derived from content produced in individual START sessions to increase transfer of skills to day to day life

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2017-06-26
• Last updated: 2021-09-05

Locations

1 site across 1 country: United States