Virtual Hope Box - Effectiveness of a Smartphone App for Coping With Suicidal Ideation

NCT ID: NCT01982773

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-04-30

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. 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. 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. 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:

1. 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?

2. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Hope Box Smartphone App

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

Group Type: EXPERIMENTAL

Virtual Hope Box Smartphone App

Intervention Type: BEHAVIORAL

Smartphone app

EnhancedTreatment As Usual

Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.

Group Type: ACTIVE_COMPARATOR

Enhanced Treatment as Usual

Intervention Type: BEHAVIORAL

Printed materials

Interventions

Virtual Hope Box Smartphone App

Smartphone app

Intervention Type: BEHAVIORAL

Enhanced Treatment as Usual

Printed materials

Intervention Type: BEHAVIORAL

Other Intervention Names

VHB; ETAU

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Geneva Foundation

OTHER

Sponsor Role: collaborator

Portland VA Medical Center

FED

Sponsor Role: collaborator

National Center for Telehealth and Technology

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nigel E Bush, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Telehealth and Technology

Steven K Dobscha, MD

Role: PRINCIPAL_INVESTIGATOR

Portland VA Medical Center

Locations

Portland VA Medical Center

Portland, Oregon, United States

National Center for Telehealth and Technology

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23330611 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18981347 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 19780463 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 20816034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15527502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15285970 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9989117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16938149 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20478879 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16130637 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22390612 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 18664887 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20051309 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8185865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19929120 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16287694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16135629 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19014300 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 16143727 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16953733 (View on PubMed)

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.

Reference Type: 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

Reference Type: BACKGROUND

Other Identifiers

1334

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

001-W81XWH-10-2-0178

Identifier Type: -

Identifier Source: org_study_id