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Virtual Hope Box - Effectiveness of a Smartphone App for Coping With Suicidal Ideation (VHB-RCT)

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ClinicalTrials.gov Identifier: NCT01982773
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborators:
The Geneva Foundation
Portland VA Medical Center
Information provided by (Responsible Party):
National Center for Telehealth and Technology

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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Thoughts of Self Harm Coping Behavioral: Virtual Hope Box Smartphone App Behavioral: Enhanced Treatment as Usual Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Virtual Hope Box Smartphone App in Enhancing Veterans' Coping With Suicidal Ideation: A Randomized Clinical Trial.
Study Start Date : March 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Virtual Hope Box Smartphone App
Use of the smartphone app, Virtual Hope Box on their personal smartphone
Behavioral: Virtual Hope Box Smartphone App
Smartphone app
Other Name: VHB

Active Comparator: 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.
Behavioral: Enhanced Treatment as Usual
Printed materials
Other Name: ETAU




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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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

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

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): NCT01982773


Locations
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United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239
United States, Washington
National Center for Telehealth and Technology
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
National Center for Telehealth and Technology
The Geneva Foundation
Portland VA Medical Center
Investigators
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Principal Investigator: Nigel E Bush, PhD National Center for Telehealth and Technology
Principal Investigator: Steven K Dobscha, MD Portland VA Medical Center

Publications:
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
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
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
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.
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.
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

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Responsible Party: National Center for Telehealth and Technology
ClinicalTrials.gov Identifier: NCT01982773     History of Changes
Other Study ID Numbers: 001-W81XWH-10-2-0178
1334 ( Other Grant/Funding Number: Geneva Foundation )
First Posted: November 13, 2013    Key Record Dates
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Center for Telehealth and Technology:
Virtual Hope Box

Additional relevant MeSH terms:
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Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms