Trial Outcomes & Findings for Virtual Hope Box - Effectiveness of a Smartphone App for Coping With Suicidal Ideation (NCT NCT01982773)

NCT ID: NCT01982773

Last Updated: 2018-01-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

118 participants

Primary outcome timeframe

Baseline

Results posted on

2018-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Hope Box Smartphone App Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app	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
Overall Study STARTED	58	60
Overall Study COMPLETED	50	56
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Virtual Hope Box Smartphone App Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app	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
Overall Study Withdrawal by Subject	1	3
Overall Study Lost to Follow-up	7	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Hope Box Smartphone App n=58 Participants Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app	EnhancedTreatment As Usual n=60 Participants 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 n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	50 Participants n=7 Participants	101 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	46.5 years STANDARD_DEVIATION 13.8 • n=5 Participants	48.7 years STANDARD_DEVIATION 14.3 • n=7 Participants	47.6 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	45 Participants n=7 Participants	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	50 Participants n=7 Participants	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	44 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	58 Participants n=5 Participants	60 Participants n=7 Participants	118 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Virtual Hope Box Smartphone App n=58 Participants Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app	EnhancedTreatment As Usual n=59 Participants 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
Beck Scale for Suicidal Ideation	3.31 units on a scale Standard Deviation 2.6	3.58 units on a scale Standard Deviation 2.83

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Hope Box Smartphone App n=56 Participants Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app	EnhancedTreatment As Usual n=55 Participants 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
Beck Scale for Suicidal Ideation	3.41 units on a scale Standard Deviation 2.64	3.33 units on a scale Standard Deviation 2.76

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Hope Box Smartphone App n=51 Participants Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app	EnhancedTreatment As Usual n=55 Participants 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
Beck Scale for Suicidal Ideation	2.94 units on a scale Standard Deviation 2.59	3.02 units on a scale Standard Deviation 2.82

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Hope Box Smartphone App n=49 Participants Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app	EnhancedTreatment As Usual n=55 Participants 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
Beck Scale for Suicidal Ideation	3.16 units on a scale Standard Deviation 2.7	3.2 units on a scale Standard Deviation 2.71

Adverse Events

Virtual Hope Box Smartphone App

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

EnhancedTreatment As Usual

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Virtual Hope Box Smartphone App n=58 participants at risk Use of the smartphone app, Virtual Hope Box on their personal smartphone Virtual Hope Box Smartphone App: Smartphone app	EnhancedTreatment As Usual n=60 participants at risk 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
Psychiatric disorders enhanced suicidal ideation	1.7% 1/58 • Number of events 1 • From date of randomization until the date of completion, assessed up to 12 weeks	0.00% 0/60 • From date of randomization until the date of completion, assessed up to 12 weeks
Psychiatric disorders increased depression	0.00% 0/58 • From date of randomization until the date of completion, assessed up to 12 weeks	1.7% 1/60 • Number of events 1 • From date of randomization until the date of completion, assessed up to 12 weeks

Additional Information

Nigel E. Bush, PhD

National Center for Telehealth and Technology

Phone: 253-968-4153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place