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

July 5, 2017 updated by: National Center for Telehealth and Technology

Effectiveness of a Virtual Hope Box Smartphone App in Enhancing Veterans' Coping With Suicidal Ideation: A Randomized Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center
    • Washington
      • Tacoma, Washington, United States, 98431
        • National Center for Telehealth and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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 week follow up
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.
6 week follow up
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.
12 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Telehealth and Technology

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (ESTIMATE)

November 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2018

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-W81XWH-10-2-0178
  • 1334 (Geneva Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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