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

Sponsor
National Center for Telehealth and Technology (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01982773
Collaborator
The Geneva Foundation (Other), Portland VA Medical Center (U.S. Fed)
118
Enrollment
2
Locations
2
Arms
25
Duration (Months)
59
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

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:

  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
  • Behavioral: Virtual Hope Box Smartphone App
  • Behavioral: Enhanced Treatment as Usual
 N/A

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

Study Design

Study Type:
Interventional
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 :
Mar 1, 2014
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

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 Names:
  • 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 Names:
  • ETAU

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Beck Scale for Suicidal Ideation [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Portland VA Medical Center Portland Oregon United States 97239
    2 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

    • Principal Investigator: Nigel E Bush, PhD, National Center for Telehealth and Technology
    • Principal Investigator: Steven K Dobscha, MD, Portland VA Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Center for Telehealth and Technology
    ClinicalTrials.gov Identifier:
    NCT01982773
    Other Study ID Numbers:
    • 001-W81XWH-10-2-0178
    • 1334
    First Posted:
    Nov 13, 2013
    Last Update Posted:
    Jan 30, 2018
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by National Center for Telehealth and Technology
    Virtual Hope Box
    Additional relevant MeSH terms:
    Suicidal Ideation
    Self-Injurious Behavior

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Arm/Group Description Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. Enhanced Treatment as Usual: Printed materials
    Period Title: Overall Study
    STARTED 58 60
    COMPLETED 50 56
    NOT COMPLETED 8 4

    Baseline Characteristics

    Arm/Group Title Virtual Hope Box Smartphone App EnhancedTreatment As Usual Total
    Arm/Group Description Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. Enhanced Treatment as Usual: Printed materials Total of all reporting groups
    Overall Participants 58 60 118
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    51
    87.9%
    50
    83.3%
    101
    85.6%
    >=65 years
    7
    12.1%
    10
    16.7%
    17
    14.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.5
    (13.8)
    48.7
    (14.3)
    47.6
    (14.0)
    Sex: Female, Male (Count of Participants)
    Female
    22
    37.9%
    15
    25%
    37
    31.4%
    Male
    36
    62.1%
    45
    75%
    81
    68.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    6.9%
    5
    8.3%
    9
    7.6%
    Not Hispanic or Latino
    47
    81%
    50
    83.3%
    97
    82.2%
    Unknown or Not Reported
    7
    12.1%
    5
    8.3%
    12
    10.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    3.4%
    1
    1.7%
    3
    2.5%
    Asian
    2
    3.4%
    3
    5%
    5
    4.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    3.4%
    2
    3.3%
    4
    3.4%
    White
    41
    70.7%
    44
    73.3%
    85
    72%
    More than one race
    11
    19%
    10
    16.7%
    21
    17.8%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    58
    100%
    60
    100%
    118
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Arm/Group Description Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. Enhanced Treatment as Usual: Printed materials
    Measure Participants 58 59
    Mean (Standard Deviation) [units on a scale]
    3.31
    (2.6)
    3.58
    (2.83)
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Arm/Group Description Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. Enhanced Treatment as Usual: Printed materials
    Measure Participants 56 55
    Mean (Standard Deviation) [units on a scale]
    3.41
    (2.64)
    3.33
    (2.76)
    3. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Arm/Group Description Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. Enhanced Treatment as Usual: Printed materials
    Measure Participants 51 55
    Mean (Standard Deviation) [units on a scale]
    2.94
    (2.59)
    3.02
    (2.82)
    4. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Arm/Group Description Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. Enhanced Treatment as Usual: Printed materials
    Measure Participants 49 55
    Mean (Standard Deviation) [units on a scale]
    3.16
    (2.7)
    3.2
    (2.71)

    Adverse Events

    Time Frame From date of randomization until the date of completion, assessed up to 12 weeks
    Adverse Event Reporting Description
    Arm/Group Title Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Arm/Group Description Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app Subjects will be issued printed materials guiding them in coping with suicidal thoughts, which include information about coping strategies and emergency contact information. Enhanced Treatment as Usual: Printed materials
    All Cause Mortality
    Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/58 (0%) 0/60 (0%)
    Other (Not Including Serious) Adverse Events
    Virtual Hope Box Smartphone App EnhancedTreatment As Usual
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/58 (1.7%) 1/60 (1.7%)
    Psychiatric disorders
    enhanced suicidal ideation 1/58 (1.7%) 1 0/60 (0%) 0
    increased depression 0/58 (0%) 0 1/60 (1.7%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Nigel E. Bush, PhD
    Organization National Center for Telehealth and Technology
    Phone 253-968-4153
    Email nigel.e.bush.civ@mail.mil
    Responsible Party:
    National Center for Telehealth and Technology
    ClinicalTrials.gov Identifier:
    NCT01982773
    Other Study ID Numbers:
    • 001-W81XWH-10-2-0178
    • 1334
    First Posted:
    Nov 13, 2013
    Last Update Posted:
    Jan 30, 2018
    Last Verified:
    Jul 1, 2017