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

NCT03198364 | Completed DMC

• 2 other identifiers: 1R34MH113613-019370600
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Bipolar Disorder; Suicide and Self-harm

Outcome Measures

Primary Outcomes (1)

• Scale for Suicide Ideation

  21 Item clinician rated scale

  Change in severity of suicide ideation over 24 weeks

Secondary Outcomes (1)

• Columbia Suicide Severity Rating Scale - Interval Version

  Rate of suicidal behavior over 24 weeks

Study Arms (2)

START + Mobile Augmentation

EXPERIMENTAL

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

Behavioral: Safety and Recovery Therapy; Behavioral: Mobile Augmentation

START

ACTIVE COMPARATOR

4 Sessions of In-Person Psychoeducation called Safety and Recovery Therapy (START)

Behavioral: Safety and Recovery Therapy

Interventions

Safety and Recovery Therapy BEHAVIORAL

4 session individualized psychoeducation tailored to people with bipolar disorder or schizophrenia targeting coping skills for suicidal thoughts and their determinants.

START; START + Mobile Augmentation

Mobile Augmentation BEHAVIORAL

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

START + Mobile Augmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

Related Publications (3)

• Parrish EM, Quynh A, Scott V, Chalker SA, Chang C, Kamarsu S, Twamley EW, Depp CA. Suicide Safety Plan Self-knowledge in Serious Mental Illness: Psychiatric Symptom Correlates and Effects of Brief Intervention. Community Ment Health J. 2023 Nov;59(8):1639-1646. doi: 10.1007/s10597-023-01155-5. Epub 2023 Jun 20.

  PMID: 37340170 DERIVED

• Depp CA, Parrish EM, Chalker SA, Ehret BC, Kamarsu S, Perivoliotis D, Granholm E. Pilot feasibility trial of a brief mobile-augmented suicide prevention intervention for serious mental illness. Psychiatr Rehabil J. 2023 Mar;46(1):74-82. doi: 10.1037/prj0000547.

  PMID: 36809018 DERIVED

• 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.

  PMID: 33555265 DERIVED

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Suicide; Self-Injurious Behavior

Interventions

Safety

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 26, 2017
• Study Start: March 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)