Suicidal IdeationVHB-RCTNCT01982773
Virtual Hope Box - Effectiveness of a Smartphone App for Coping With Suicidal Ideation
A study testing Virtual Hope Box Smartphone App and Enhanced Treatment as Usual in people with Suicidal Ideation and Thoughts of Self Harm, run by National Center for Telehealth and Technology at 2 sites in United States.
Trial summary
A hope box or self soothing kit is a therapeutic tool employed by clinicians with patients expressing suicidal ideation, significant distress, or otherwise at risk of suicidal or non-suicidal self harm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Thoughts of Self Harm, Coping
- What is being tested?
- Virtual Hope Box Smartphone App and Enhanced Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- US Service Veterans in active treatment by Portland VA mental health clinicians
- Patients expressing suicidal ideation, thoughts of suicidal self-harm, or determined to be at "high risk" for suicide by treating clinician or Suicide Prevention Team
- Patients owning and regularly using/carrying their own iPhone or Android phones
- Patients identified as clinically suitable by their clinicians for hope box utilization or enhanced treatment as usual (ETAU) as part of treatment
Who cannot join
- Moderate or severe dementia or significant cognitive disturbance as indicated by chart diagnosis of dementia or score of greater than or equal to 10 on the Short Blessed questionnaire during screening
- Patients considered terminally ill according to documentation in patient records
- Patients with designated guardians, who are unable to provide consent without the assistance of a legally authorized representative or guardian
- Patients admitted to inpatient unit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Portland VA Medical Center
Portland, Oregon, 97239
National Center for Telehealth and Technology
Tacoma, Washington, 98431
About this study
Official title: Effectiveness of a Virtual Hope Box Smartphone App in Enhancing Veterans' Coping With Suicidal Ideation: A Randomized Clinical Trial.
A hope box or self soothing kit is a therapeutic tool employed by clinicians with patients expressing suicidal ideation, significant distress, or otherwise at risk of suicidal or non-suicidal self harm. A "Virtual Hope Box" (VHB) takes the common hope box practice and uses smartphone features to enhance the experience. The rich multimedia features on a smartphone allow more varied options. Furthermore, these devices are already a common repository for user-generated and user-preferred media, which will allow for a highly personalized VHB that is highly portable and always available to a user in distress. We hypothesize that:
- Patients in the (VHB) intervention condition will demonstrate pre-post reductions in 1) severity of suicidal ideation 2) ability to cope with stressors and 3) increases in perceived reasons for living
- Patients in the intervention condition will demonstrate greater pre-post reductions in symptoms of suicidal ideation, ability to cope with stressors, and perceived reasons for living compared to patients in the (ETAU) control condition.
- Patients and clinicians will find VHB to be beneficial and its use readily integrated into practice.
Read the detailed description
Our overall objective in the proposed study is to assess the impact of a virtual hope-box (VHB) smartphone app on suicidal ideation in veterans undergoing clinical therapy who have recently had suicidal ideation or behavior. We propose to conduct this study in two phases:
Phase 1: Modifying the current VHB-β version of the app to accommodate feedback from pilot study participants. The result will be the VHB V1.0 to be tested in phase 2. This component of the study will be conducted by the T2 group located at Joint Base Lewis-McChord.
Phase 2: Implementing a randomized controlled trial comparing the VHB intervention with enhanced treatment as usual (ETAU) in clinical practice. This component of the study will be conducted at the Portland VA Medical Center.
This research project seeks to answer several essential questions:
- Can a smartphone app containing the essential components of a hope box and associated elements of CT/DBT (Dialectical Behavioral Therapy) reduce severity of suicidal ideation, and increase perceptions of reasons for living and ability to cope, in a clinical sample of veterans?
- Is a smartphone VHB app more effective in reducing severity of suicidal ideation, and increasing perceptions of reasons for living and ability to cope, compared to enhanced treatment as usual (ETAU)? In addition, we will gather important information about implementing and integrating VHB as a treatment component in mental health treatment
- Conditions
- Suicidal Ideation, Thoughts of Self Harm, Coping
- Being tested
- Virtual Hope Box Smartphone App, Enhanced Treatment as Usual
- Keywords
- Virtual Hope Box
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Hope Box Smartphone AppBehavioural
Also called VHB
Smartphone app
Enhanced Treatment as UsualBehavioural
Also called ETAU
Printed materials
| Study group | Role | What they receive |
|---|---|---|
| Virtual Hope Box Smartphone App | Experimental | Use of the smartphone app, Virtual Hope Box on their personal smartphone Receives: Behavioral: Virtual Hope Box Smartphone App |
| EnhancedTreatment As Usual | Active comparator | Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. Receives: Behavioral: Enhanced Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Scale for Suicidal Ideation
measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48. The higher the score indicated the greater risk for suicidal ideation.
Measured: Baseline
Beck Scale for Suicidal Ideation
measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.
Measured: 3 week follow up
Beck Scale for Suicidal Ideation
measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.
Measured: 6 week follow up
Beck Scale for Suicidal Ideation
measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.
Measured: 12 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Telehealth and Technology
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation, Portland VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Nigel E Bush, PhD, Principal investigator, National Center for Telehealth and TechnologySteven K Dobscha, MD, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982773
- Sponsor's protocol ID
- 001-W81XWH-10-2-0178
- Other IDs
- 1334
- Acronym
- VHB-RCT
- Status last verified
- Jul 2017
- First submitted
- 6 Nov 2013
- Last updated
- 30 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bush NE, Reger MA, Luxton DD, Skopp NA, Kinn J, Smolenski D, Gahm GA. Suicides and suicide attempts in the U.S. Military, 2008-2010. Suicide Life Threat Behav. 2013 Jun;43(3):262-73. doi: 10.1111/sltb.12012. Epub 2013 Jan 17.
PubMed 23330611Chartrand MM, Frank DA, White LF, Shope TR. Effect of parents' wartime deployment on the behavior of young children in military families. Arch Pediatr Adolesc Med. 2008 Nov;162(11):1009-14. doi: 10.1001/archpedi.162.11.1009.
PubMed 18981347Luxton DD, Osenbach JE, Regar MA, et al. Department of Defense Suicide Event Report (DoDSER): Calendar Year 2011 Annual Report: National Center for Telehealth and Technology, Defense Centers of Excellence for Psychological Health & TBI (DCOE); 2011
Kemp J, Bossarte RM. Suicide Data Report, 2012: Department of Veterans Affairs, Mental Health Services, Suicide Prevention Program; 2012
National Violent Death Reporting System. Centers for Disease Control and Prevention http://www.cdc.gov/ViolencePrevention/NVDRS/index.html, 2009
Savitsky L, Illingworth M, DuLaney M. Civilian social work: serving the military and veteran populations. Soc Work. 2009 Oct;54(4):327-39. doi: 10.1093/sw/54.4.327.
PubMed 19780463Congressional testimony of hearing on veteran suicide prevention by panel of experts from the U.S. Department of Veterans Affairs before the U.S. House Veterans' Affairs Subcommittee on Health December 2.2011. U.S. House Veterans' Affairs Subcommittee on Health 2011
Borges G, Nock MK, Haro Abad JM, Hwang I, Sampson NA, Alonso J, Andrade LH, Angermeyer MC, Beautrais A, Bromet E, Bruffaerts R, de Girolamo G, Florescu S, Gureje O, Hu C, Karam EG, Kovess-Masfety V, Lee S, Levinson D, Medina-Mora ME, Ormel J, Posada-Villa J, Sagar R, Tomov T, Uda H, Williams DR, Kessler RC. Twelve-month prevalence of and risk factors for suicide attempts in the World Health Organization World Mental Health Surveys. J Clin Psychiatry. 2010 Dec;71(12):1617-28. doi: 10.4088/JCP.08m04967blu. Epub 2010 Aug 24.
PubMed 20816034Arsenault-Lapierre G, Kim C, Turecki G. Psychiatric diagnoses in 3275 suicides: a meta-analysis. BMC Psychiatry. 2004 Nov 4;4:37. doi: 10.1186/1471-244X-4-37.
PubMed 15527502Oquendo MA, Galfalvy H, Russo S, Ellis SP, Grunebaum MF, Burke A, Mann JJ. Prospective study of clinical predictors of suicidal acts after a major depressive episode in patients with major depressive disorder or bipolar disorder. Am J Psychiatry. 2004 Aug;161(8):1433-41. doi: 10.1176/appi.ajp.161.8.1433.
PubMed 15285970Hall RC, Platt DE, Hall RC. Suicide risk assessment: a review of risk factors for suicide in 100 patients who made severe suicide attempts. Evaluation of suicide risk in a time of managed care. Psychosomatics. 1999 Jan-Feb;40(1):18-27. doi: 10.1016/S0033-3182(99)71267-3.
PubMed 9989117Borges G, Angst J, Nock MK, Ruscio AM, Walters EE, Kessler RC. A risk index for 12-month suicide attempts in the National Comorbidity Survey Replication (NCS-R). Psychol Med. 2006 Dec;36(12):1747-57. doi: 10.1017/S0033291706008786. Epub 2006 Aug 29.
PubMed 16938149Holma KM, Melartin TK, Haukka J, Holma IA, Sokero TP, Isometsa ET. Incidence and predictors of suicide attempts in DSM-IV major depressive disorder: a five-year prospective study. Am J Psychiatry. 2010 Jul;167(7):801-8. doi: 10.1176/appi.ajp.2010.09050627. Epub 2010 May 17.
PubMed 20478879Allen JP, Cross G, Swanner J. Suicide in the Army: a review of current information. Mil Med. 2005 Jul;170(7):580-4. doi: 10.7205/milmed.170.7.580.
PubMed 16130637Blow FC, Bohnert AS, Ilgen MA, Ignacio R, McCarthy JF, Valenstein MM, Knox KL. Suicide mortality among patients treated by the Veterans Health Administration from 2000 to 2007. Am J Public Health. 2012 Mar;102 Suppl 1(Suppl 1):S98-104. doi: 10.2105/AJPH.2011.300441.
PubMed 22390612
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Virtual Hope Box Smartphone App in Enhancing Veterans' Coping With Suicidal Ideation: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01982773
- Acronym / sponsor ID
- VHB-RCT / 001-W81XWH-10-2-0178
- Conditions
- Suicidal Ideation, Thoughts of Self Harm, Coping
- Keywords
- Virtual Hope Box
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Center for Telehealth and TechnologyUS federal agency
- Collaborators
- The Geneva Foundation, Portland VA Medical Center
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 30 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A hope box or self soothing kit is a therapeutic tool employed by clinicians with patients expressing suicidal ideation, significant distress, or otherwise at risk of suicidal or non-suicidal self harm. A "Virtual Hope Box" (VHB) takes the common hope box practice and uses smartphone features to enhance the experience. The rich multimedia features on a smartphone allow more varied options. Furthermore, these devices are already a common repository for user-generated and user-preferred media, which will allow for a highly personalized VHB that is highly portable and always available to a user in distress. We hypothesize that:
- Patients in the (VHB) intervention condition will demonstrate pre-post reductions in 1) severity of suicidal ideation 2) ability to cope with stressors and 3) increases in perceived reasons for living
- Patients in the intervention condition will demonstrate greater pre-post reductions in symptoms of suicidal ideation, ability to cope with stressors, and perceived reasons for living compared to patients in the (ETAU) control condition.
- Patients and clinicians will find VHB to be beneficial and its use readily integrated into practice.
Detailed description
Our overall objective in the proposed study is to assess the impact of a virtual hope-box (VHB) smartphone app on suicidal ideation in veterans undergoing clinical therapy who have recently had suicidal ideation or behavior. We propose to conduct this study in two phases:
Phase 1: Modifying the current VHB-β version of the app to accommodate feedback from pilot study participants. The result will be the VHB V1.0 to be tested in phase 2. This component of the study will be conducted by the T2 group located at Joint Base Lewis-McChord.
Phase 2: Implementing a randomized controlled trial comparing the VHB intervention with enhanced treatment as usual (ETAU) in clinical practice. This component of the study will be conducted at the Portland VA Medical Center.
This research project seeks to answer several essential questions:
- Can a smartphone app containing the essential components of a hope box and associated elements of CT/DBT (Dialectical Behavioral Therapy) reduce severity of suicidal ideation, and increase perceptions of reasons for living and ability to cope, in a clinical sample of veterans?
- Is a smartphone VHB app more effective in reducing severity of suicidal ideation, and increasing perceptions of reasons for living and ability to cope, compared to enhanced treatment as usual (ETAU)? In addition, we will gather important information about implementing and integrating VHB as a treatment component in mental health treatment
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Hope Box Smartphone App | Experimental | Behavioral: Virtual Hope Box Smartphone AppUse of the smartphone app, Virtual Hope Box on their personal smartphone |
| EnhancedTreatment As Usual | Active comparator | Behavioral: Enhanced Treatment as UsualSubjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- US Service Veterans in active treatment by Portland VA mental health clinicians
- Patients expressing suicidal ideation, thoughts of suicidal self-harm, or determined to be at "high risk" for suicide by treating clinician or Suicide Prevention Team
- Patients owning and regularly using/carrying their own iPhone or Android phones
- Patients identified as clinically suitable by their clinicians for hope box utilization or enhanced treatment as usual (ETAU) as part of treatment
Key exclusion criteria (4 listed)
- Moderate or severe dementia or significant cognitive disturbance as indicated by chart diagnosis of dementia or score of greater than or equal to 10 on the Short Blessed questionnaire during screening
- Patients considered terminally ill according to documentation in patient records
- Patients with designated guardians, who are unable to provide consent without the assistance of a legally authorized representative or guardian
- Patients admitted to inpatient unit
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 |
|---|---|---|
| Virtual Hope Box Smartphone AppAlso: VHBSmartphone app | Behavioural | Virtual Hope Box Smartphone App |
| Enhanced Treatment as UsualAlso: ETAUPrinted materials | Behavioural | EnhancedTreatment As Usual |
Primary outcome
Beck Scale for Suicidal Ideation
Time frame: Baseline
measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48. The higher the score indicated the greater risk for suicidal ideation.
Beck Scale for Suicidal Ideation
Time frame: 3 week follow up
measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.
Beck Scale for Suicidal Ideation
Time frame: 6 week follow up
measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.
Beck Scale for Suicidal Ideation
Time frame: 12 week follow up
measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23330611Bush NE, Reger MA, Luxton DD, Skopp NA, Kinn J, Smolenski D, Gahm GA. Suicides and suicide attempts in the U.S. Military, 2008-2010. Suicide Life Threat Behav. 2013 Jun;43(3):262-73. doi: 10.1111/sltb.12012. Epub 2013 Jan 17.
- Background: PubMed 18981347Chartrand MM, Frank DA, White LF, Shope TR. Effect of parents' wartime deployment on the behavior of young children in military families. Arch Pediatr Adolesc Med. 2008 Nov;162(11):1009-14. doi: 10.1001/archpedi.162.11.1009.
- BackgroundLuxton DD, Osenbach JE, Regar MA, et al. Department of Defense Suicide Event Report (DoDSER): Calendar Year 2011 Annual Report: National Center for Telehealth and Technology, Defense Centers of Excellence for Psychological Health & TBI (DCOE); 2011
- BackgroundKemp J, Bossarte RM. Suicide Data Report, 2012: Department of Veterans Affairs, Mental Health Services, Suicide Prevention Program; 2012
- BackgroundNational Violent Death Reporting System. Centers for Disease Control and Prevention http://www.cdc.gov/ViolencePrevention/NVDRS/index.html, 2009
- Background: PubMed 19780463Savitsky L, Illingworth M, DuLaney M. Civilian social work: serving the military and veteran populations. Soc Work. 2009 Oct;54(4):327-39. doi: 10.1093/sw/54.4.327.
- BackgroundCongressional testimony of hearing on veteran suicide prevention by panel of experts from the U.S. Department of Veterans Affairs before the U.S. House Veterans' Affairs Subcommittee on Health December 2.2011. U.S. House Veterans' Affairs Subcommittee on Health 2011
- Background: PubMed 20816034Borges G, Nock MK, Haro Abad JM, Hwang I, Sampson NA, Alonso J, Andrade LH, Angermeyer MC, Beautrais A, Bromet E, Bruffaerts R, de Girolamo G, Florescu S, Gureje O, Hu C, Karam EG, Kovess-Masfety V, Lee S, Levinson D, Medina-Mora ME, Ormel J, Posada-Villa J, Sagar R, Tomov T, Uda H, Williams DR, Kessler RC. Twelve-month prevalence of and risk factors for suicide attempts in the World Health Organization World Mental Health Surveys. J Clin Psychiatry. 2010 Dec;71(12):1617-28. doi: 10.4088/JCP.08m04967blu. Epub 2010 Aug 24.
- Background: PubMed 15527502Arsenault-Lapierre G, Kim C, Turecki G. Psychiatric diagnoses in 3275 suicides: a meta-analysis. BMC Psychiatry. 2004 Nov 4;4:37. doi: 10.1186/1471-244X-4-37.
- Background: PubMed 15285970Oquendo MA, Galfalvy H, Russo S, Ellis SP, Grunebaum MF, Burke A, Mann JJ. Prospective study of clinical predictors of suicidal acts after a major depressive episode in patients with major depressive disorder or bipolar disorder. Am J Psychiatry. 2004 Aug;161(8):1433-41. doi: 10.1176/appi.ajp.161.8.1433.
- Background: PubMed 9989117Hall RC, Platt DE, Hall RC. Suicide risk assessment: a review of risk factors for suicide in 100 patients who made severe suicide attempts. Evaluation of suicide risk in a time of managed care. Psychosomatics. 1999 Jan-Feb;40(1):18-27. doi: 10.1016/S0033-3182(99)71267-3.
- Background: PubMed 16938149Borges G, Angst J, Nock MK, Ruscio AM, Walters EE, Kessler RC. A risk index for 12-month suicide attempts in the National Comorbidity Survey Replication (NCS-R). Psychol Med. 2006 Dec;36(12):1747-57. doi: 10.1017/S0033291706008786. Epub 2006 Aug 29.
- Individual participant dataSharing planned: No
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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.
Nigel E Bush, PhD principal investigator
National Center for Telehealth and Technology
Steven K Dobscha, MD principal investigator
Portland VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Hope Box Smartphone App and Enhanced Treatment as Usual in people with Suicidal Ideation and Thoughts of Self Harm, run by National Center for Telehealth and Technology at 2 sites 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 4 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 30 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Beck Scale for Suicidal Ideation (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT01982773, which also lists 27 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 30 Jan 2018.