Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI
Primary Purpose
Schizophrenia, Bipolar Disorder, Suicide and Self-harm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety and Recovery Therapy
Mobile Augmentation
Sponsored by
About this trial
This is an interventional health services research trial for Schizophrenia
Eligibility Criteria
All subjects are recruited from San Diego area "walk-in" behavioral health evaluation services and must be referred by a triage clinician at such facilities. The study is unable to accept referrals from other sources. In addition, the following criteria apply:
Inclusion Criteria:
- Subjects must have present suicidal ideation CSSR-S> 2 ("Active thoughts of killing oneself") in past 1 month and/or a suicide attempt in the prior 3 months as identified by the Columbia Suicide Severity Rating Scale
- Diagnosis of DSM-V bipolar disorder, schizophrenia, or schizoaffective disorder as identified by the MINI International Neuropsychiatric Interview
- Plans to remain in San Diego region for at least 6 months,
- Capable of informed consent.
Exclusion Criteria:
- Not English speaking
- Cannot complete the assessment battery;
- Insufficient visual acuity/manual dexterity for navigating a touch screen;
- Current intoxication or substance use requiring immediate detoxification or outpatient plan directed at substance abuse services (versus mental health services which are separate in San Diego county);
- Under conservatorship requiring proxy consent.
Sites / Locations
- University of California, San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
START + Mobile Augmentation
START
Arm Description
4 Sessions of In-Person Psychoeducation called Safety and Recovery Therapy (START) with 12 weeks of augmentation by use of automated software to prompt users to engage in personalized adaptive coping
4 Sessions of In-Person Psychoeducation called Safety and Recovery Therapy (START)
Outcomes
Primary Outcome Measures
Scale for Suicide Ideation
21 Item clinician rated scale
Secondary Outcome Measures
Columbia Suicide Severity Rating Scale - Interval Version
Measure of the presence and severity of ideation and behavior over a defined interval
Full Information
NCT ID
NCT03198364
First Posted
June 20, 2017
Last Updated
September 3, 2021
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03198364
Brief Title
Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI
Official Title
Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI Accessing Community Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Suicide and Self-harm
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
START + Mobile Augmentation
Arm Type
Experimental
Arm Description
4 Sessions of In-Person Psychoeducation called Safety and Recovery Therapy (START) with 12 weeks of augmentation by use of automated software to prompt users to engage in personalized adaptive coping
Arm Title
START
Arm Type
Active Comparator
Arm Description
4 Sessions of In-Person Psychoeducation called Safety and Recovery Therapy (START)
Intervention Type
Behavioral
Intervention Name(s)
Safety and Recovery Therapy
Intervention Description
4 session individualized psychoeducation tailored to people with bipolar disorder or schizophrenia targeting coping skills for suicidal thoughts and their determinants.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Augmentation
Intervention Description
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
Primary Outcome Measure Information:
Title
Scale for Suicide Ideation
Description
21 Item clinician rated scale
Time Frame
Change in severity of suicide ideation over 24 weeks
Secondary Outcome Measure Information:
Title
Columbia Suicide Severity Rating Scale - Interval Version
Description
Measure of the presence and severity of ideation and behavior over a defined interval
Time Frame
Rate of suicidal behavior over 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
All subjects are recruited from San Diego area "walk-in" behavioral health evaluation services and must be referred by a triage clinician at such facilities. The study is unable to accept referrals from other sources. In addition, the following criteria apply:
Inclusion Criteria:
Subjects must have present suicidal ideation CSSR-S> 2 ("Active thoughts of killing oneself") in past 1 month and/or a suicide attempt in the prior 3 months as identified by the Columbia Suicide Severity Rating Scale
Diagnosis of DSM-V bipolar disorder, schizophrenia, or schizoaffective disorder as identified by the MINI International Neuropsychiatric Interview
Plans to remain in San Diego region for at least 6 months,
Capable of informed consent.
Exclusion Criteria:
Not English speaking
Cannot complete the assessment battery;
Insufficient visual acuity/manual dexterity for navigating a touch screen;
Current intoxication or substance use requiring immediate detoxification or outpatient plan directed at substance abuse services (versus mental health services which are separate in San Diego county);
Under conservatorship requiring proxy consent.
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33555265
Citation
Depp C, Ehret B, Villa J, Perivoliotis D, Granholm E. A Brief Mobile-Augmented Suicide Prevention Intervention for People With Psychotic Disorders in Transition From Acute to Ongoing Care: Protocol for a Pilot Trial. JMIR Res Protoc. 2021 Feb 8;10(2):e14378. doi: 10.2196/14378.
Results Reference
derived
Learn more about this trial
Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI
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