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

Primary Purpose

Suicidal Ideation, Thoughts of Self Harm, Coping

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Hope Box Smartphone App
Enhanced Treatment as Usual
Sponsored by
National Center for Telehealth and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Suicidal Ideation focused on measuring Virtual Hope Box

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Portland VA Medical Center
  • National Center for Telehealth and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Hope Box Smartphone App

EnhancedTreatment As Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2013
Last Updated
July 5, 2017
Sponsor
National Center for Telehealth and Technology
Collaborators
The Geneva Foundation, Portland VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01982773
Brief Title
Virtual Hope Box - Effectiveness of a Smartphone App for Coping With Suicidal Ideation
Acronym
VHB-RCT
Official Title
Effectiveness of a Virtual Hope Box Smartphone App in Enhancing Veterans' Coping With Suicidal Ideation: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Telehealth and Technology
Collaborators
The Geneva Foundation, Portland VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Thoughts of Self Harm, Coping
Keywords
Virtual Hope Box

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Hope Box Smartphone App
Arm Type
Experimental
Arm Description
Use of the smartphone app, Virtual Hope Box on their personal smartphone
Arm Title
EnhancedTreatment As Usual
Arm Type
Active Comparator
Arm Description
Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Hope Box Smartphone App
Other Intervention Name(s)
VHB
Intervention Description
Smartphone app
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment as Usual
Other Intervention Name(s)
ETAU
Intervention Description
Printed materials
Primary Outcome Measure Information:
Title
Beck Scale for Suicidal Ideation
Description
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.
Time Frame
Baseline
Title
Beck Scale for Suicidal Ideation
Description
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.
Time Frame
3 week follow up
Title
Beck Scale for Suicidal Ideation
Description
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.
Time Frame
6 week follow up
Title
Beck Scale for Suicidal Ideation
Description
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.
Time Frame
12 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel E Bush, PhD
Organizational Affiliation
National Center for Telehealth and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven K Dobscha, MD
Organizational Affiliation
Portland VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
National Center for Telehealth and Technology
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Virtual Hope Box - Effectiveness of a Smartphone App for Coping With Suicidal Ideation

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