SchizophreniaNCT03198364
Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI
A study testing Safety and Recovery Therapy and Mobile Augmentation in people with Schizophrenia and Bipolar Disorder, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Suicide and Self-harm
- What is being tested?
- Safety and Recovery Therapy and Mobile Augmentation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92037
About this study
Official title: Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI Accessing Community Care
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.
Read the 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
- Being tested
- Safety and Recovery Therapy, Mobile Augmentation
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety and Recovery TherapyBehavioural
4 session individualized psychoeducation tailored to people with bipolar disorder or schizophrenia targeting coping skills for suicidal thoughts and their determinants.
Mobile AugmentationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Safety and Recovery Therapy; Behavioral: Mobile Augmentation |
| START | Active comparator | 4 Sessions of In-Person Psychoeducation called Safety and Recovery Therapy (START) Receives: Behavioral: Safety and Recovery Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Suicide Ideation
21 Item clinician rated scale
Measured: Change in severity of suicide ideation over 24 weeks
Secondary outcomes (1)
Columbia Suicide Severity Rating Scale - Interval Version
Measure of the presence and severity of ideation and behavior over a defined interval
Measured: Rate of suicidal behavior over 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Mar 2018
- Primary completion31 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Colin Depp, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198364
- Sponsor's protocol ID
- 1R34MH113613-01
- Other IDs
- 9370600
- Status last verified
- Sep 2021
- First submitted
- 20 Jun 2017
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37340170Depp 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.
PubMed 36809018Depp 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.
PubMed 33555265
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI Accessing Community Care
- ClinicalTrials.gov ID
- NCT03198364
- Acronym / sponsor ID
- 1R34MH113613-01
- Conditions
- Schizophrenia, Bipolar Disorder, Suicide and Self-harm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| START + Mobile Augmentation | Experimental | Behavioral: Safety and Recovery Therapy, Behavioral: Mobile Augmentation4 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 |
| START | Active comparator | Behavioral: Safety and Recovery Therapy4 Sessions of In-Person Psychoeducation called Safety and Recovery Therapy (START) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety and Recovery Therapy4 session individualized psychoeducation tailored to people with bipolar disorder or schizophrenia targeting coping skills for suicidal thoughts and their determinants. | Behavioural | START, START + Mobile Augmentation |
| Mobile AugmentationThough 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 | Behavioural | START + Mobile Augmentation |
Primary outcome
Scale for Suicide Ideation
Time frame: Change in severity of suicide ideation over 24 weeks
21 Item clinician rated scale
1 secondary outcome
Columbia Suicide Severity Rating Scale - Interval Version
Time frame: Rate of suicidal behavior over 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 37340170Parrish 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.
- Derived from this study: PubMed 36809018Depp 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.
- Derived from this study: PubMed 33555265Depp 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.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Patients With Schizophrenia-like Disorders
RecruitingPhase 2
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia
Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety and Recovery Therapy and Mobile Augmentation in people with Schizophrenia and Bipolar Disorder, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Suicide Ideation (time frame: Change in severity of suicide ideation over 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198364, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.