NCT01982773

Brief 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. 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:

  1. 1.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
  2. 2.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.
  3. 3.Patients and clinicians will find VHB to be beneficial and its use readily integrated into practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

November 6, 2013

Results QC Date

January 9, 2017

Last Update Submit

July 5, 2017

Conditions

Keywords

Virtual Hope Box

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    12 week follow up

Study Arms (2)

Virtual Hope Box Smartphone App

EXPERIMENTAL

Use of the smartphone app, Virtual Hope Box on their personal smartphone

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.

Behavioral: Enhanced Treatment as Usual

Interventions

Smartphone app

Also known as: VHB
Virtual Hope Box Smartphone App

Printed materials

Also known as: ETAU
EnhancedTreatment As Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

National Center for Telehealth and Technology

Tacoma, Washington, 98431, United States

Location

Related Publications (27)

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    PMID: 23330611BACKGROUND
  • Chartrand 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.

    PMID: 18981347BACKGROUND
  • Luxton 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

    BACKGROUND
  • Kemp J, Bossarte RM. Suicide Data Report, 2012: Department of Veterans Affairs, Mental Health Services, Suicide Prevention Program; 2012

    BACKGROUND
  • National Violent Death Reporting System. Centers for Disease Control and Prevention http://www.cdc.gov/ViolencePrevention/NVDRS/index.html, 2009

    BACKGROUND
  • 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.

    PMID: 19780463BACKGROUND
  • Congressional 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
  • 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.

    PMID: 20816034BACKGROUND
  • Arsenault-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.

    PMID: 15527502BACKGROUND
  • Oquendo 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.

    PMID: 15285970BACKGROUND
  • Hall 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.

    PMID: 9989117BACKGROUND
  • Borges 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.

    PMID: 16938149BACKGROUND
  • Holma 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.

    PMID: 20478879BACKGROUND
  • Allen 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.

    PMID: 16130637BACKGROUND
  • Blow 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.

    PMID: 22390612BACKGROUND
  • Oldham J. PTSD and Suicide. J Psychiatr Pract. 2008 Jul;14(4):195. doi: 10.1097/01.pra.0000327308.50787.45. No abstract available.

    PMID: 18664887BACKGROUND
  • Selby EA, Anestis MD, Bender TW, Ribeiro JD, Nock MK, Rudd MD, Bryan CJ, Lim IC, Baker MT, Gutierrez PM, Joiner TE Jr. Overcoming the fear of lethal injury: evaluating suicidal behavior in the military through the lens of the Interpersonal-Psychological Theory of Suicide. Clin Psychol Rev. 2010 Apr;30(3):298-307. doi: 10.1016/j.cpr.2009.12.004. Epub 2009 Dec 13.

    PMID: 20051309BACKGROUND
  • Fontana A, Rosenheck R. Traumatic war stressors and psychiatric symptoms among World War II, Korean, and Vietnam War veterans. Psychol Aging. 1994 Mar;9(1):27-33. doi: 10.1037//0882-7974.9.1.27.

    PMID: 8185865BACKGROUND
  • Brenner LA, Homaifar BY, Adler LE, Wolfman JH, Kemp J. Suicidality and veterans with a history of traumatic brain injury: precipitants events, protective factors, and prevention strategies. Rehabil Psychol. 2009 Nov;54(4):390-397. doi: 10.1037/a0017802.

    PMID: 19929120BACKGROUND
  • Bodner E, Ben-Artzi E, Kaplan Z. Soldiers who kill themselves: the contribution of dispositional and situational factors. Arch Suicide Res. 2006;10(1):29-43. doi: 10.1080/13811110500318299.

    PMID: 16287694BACKGROUND
  • Mahon MJ, Tobin JP, Cusack DA, Kelleher C, Malone KM. Suicide among regular-duty military personnel: a retrospective case-control study of occupation-specific risk factors for workplace suicide. Am J Psychiatry. 2005 Sep;162(9):1688-96. doi: 10.1176/appi.ajp.162.9.1688.

    PMID: 16135629BACKGROUND
  • Linehan MM. Suicide intervention research: a field in desperate need of development. Suicide Life Threat Behav. 2008 Oct;38(5):483-5. doi: 10.1521/suli.2008.38.5.483. No abstract available.

    PMID: 19014300BACKGROUND
  • Rudd MD, Joiner TE, Jobes DA, King CA. The outpatient treatment of suicidality: An integration of science and recognition of its limitations. Professional Psychology: Research and Practice. 1999; 437-446.

    BACKGROUND
  • Beck AT. The current state of cognitive therapy: a 40-year retrospective. Arch Gen Psychiatry. 2005 Sep;62(9):953-9. doi: 10.1001/archpsyc.62.9.953.

    PMID: 16143727BACKGROUND
  • Linehan MM, Comtois KA, Brown MZ, Heard HL, Wagner A. Suicide Attempt Self-Injury Interview (SASII): development, reliability, and validity of a scale to assess suicide attempts and intentional self-injury. Psychol Assess. 2006 Sep;18(3):303-12. doi: 10.1037/1040-3590.18.3.303.

    PMID: 16953733BACKGROUND
  • O'Neil ME, Peterson K, Low A, et al. Suicide Prevention Interventions and Referral/Follow Up Services: A Systematic Review. Portland, OR: Evidence-based Synthesis Program (ESP) Center Portland VA Medical Center; March 2012 2012.

    BACKGROUND
  • Driscoll KA, Cukrowicz DC, Reardon ML, Joiner TE. Simple treatment for complex problems: A flexible cognitive behavior analysis system approach to psychotherapy Mahwah, New Jersey: Lawrence Erlbaum Associates, Inc.; 2004

    BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Results Point of Contact

Title
Nigel E. Bush, PhD
Organization
National Center for Telehealth and Technology

Study Officials

  • Nigel E Bush, PhD

    National Center for Telehealth and Technology

    PRINCIPAL INVESTIGATOR
  • Steven K Dobscha, MD

    Portland VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 30, 2018

Results First Posted

January 30, 2018

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations