Coping, Suicidal Ideation, Thoughts of Self Harm
Conditions
Keywords
Virtual Hope Box
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
Interventions
BEHAVIORALEnhanced Treatment as Usual
Printed materials
BEHAVIORALVirtual Hope Box Smartphone App
Smartphone app
Sponsors
The Geneva Foundation
Portland VA Medical Center
National Center for Telehealth and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Hope Box Smartphone App Use of the smartphone app, Virtual Hope Box on their personal smartphone
Virtual Hope Box Smartphone App: Smartphone app | 58 |
| 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.
Enhanced Treatment as Usual: Printed materials | 60 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Virtual Hope Box Smartphone App | EnhancedTreatment As Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 10 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 50 Participants | 101 Participants |
| Age, Continuous | 46.5 years STANDARD_DEVIATION 13.8 | 48.7 years STANDARD_DEVIATION 14.3 | 47.6 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 50 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 10 Participants | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 44 Participants | 85 Participants |
| Region of Enrollment United States | 58 Participants | 60 Participants | 118 Participants |
| Sex: Female, Male Female | 22 Participants | 15 Participants | 37 Participants |
| Sex: Female, Male Male | 36 Participants | 45 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 58 | 1 / 60 |
| serious Total, serious adverse events | 0 / 58 | 0 / 60 |
Outcome results
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Hope Box Smartphone App | Beck Scale for Suicidal Ideation | 3.31 units on a scale | Standard Deviation 2.6 |
| EnhancedTreatment As Usual | Beck Scale for Suicidal Ideation | 3.58 units on a scale | Standard Deviation 2.83 |
Primary
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.
Time frame: 3 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Hope Box Smartphone App | Beck Scale for Suicidal Ideation | 3.41 units on a scale | Standard Deviation 2.64 |
| EnhancedTreatment As Usual | Beck Scale for Suicidal Ideation | 3.33 units on a scale | Standard Deviation 2.76 |
Primary
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.
Time frame: 6 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Hope Box Smartphone App | Beck Scale for Suicidal Ideation | 2.94 units on a scale | Standard Deviation 2.59 |
| EnhancedTreatment As Usual | Beck Scale for Suicidal Ideation | 3.02 units on a scale | Standard Deviation 2.82 |
Primary
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.
Time frame: 12 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Hope Box Smartphone App | Beck Scale for Suicidal Ideation | 3.16 units on a scale | Standard Deviation 2.7 |
| EnhancedTreatment As Usual | Beck Scale for Suicidal Ideation | 3.2 units on a scale | Standard Deviation 2.71 |