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

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ClinicalTrials.gov Identifier: NCT03198364
Recruitment Status : Enrolling by invitation
First Posted : June 26, 2017
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Colin Depp, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Suicide and Self-harm Behavioral: Safety and Recovery Therapy Behavioral: Mobile Augmentation Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI Accessing Community Care
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: START + Mobile Augmentation
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
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

Active Comparator: START
4 Sessions of In-Person Psychoeducation called Safety and Recovery Therapy (START)
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.




Primary Outcome Measures :
  1. Scale for Suicide Ideation [ Time Frame: Change in severity of suicide ideation over 24 weeks ]
    21 Item clinician rated scale


Secondary Outcome Measures :
  1. Columbia Suicide Severity Rating Scale - Interval Version [ Time Frame: Rate of suicidal behavior over 24 weeks ]
    Measure of the presence and severity of ideation and behavior over a defined interval



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. 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
  2. Diagnosis of DSM-V bipolar disorder, schizophrenia, or schizoaffective disorder as identified by the MINI International Neuropsychiatric Interview
  3. Plans to remain in San Diego region for at least 6 months,
  4. Capable of informed consent.

Exclusion Criteria:

  1. Not English speaking
  2. Cannot complete the assessment battery;
  3. Insufficient visual acuity/manual dexterity for navigating a touch screen;
  4. 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);
  5. Under conservatorship requiring proxy consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198364


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)

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Responsible Party: Colin Depp, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03198364     History of Changes
Other Study ID Numbers: 1R34MH113613-01 ( U.S. NIH Grant/Contract )
9370600 ( Other Grant/Funding Number: NIMH )
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Suicide
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Self-Injurious Behavior
Behavioral Symptoms