Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000497303
Ethics application status
Approved
Date submitted
30/03/2017
Date registered
6/04/2017
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the viability and efficacy of integrating the BeyondNow suicide prevention smartphone app into a telephone support service for callers who are experiencing suicidal thoughts.
Scientific title
A study to evaluate the viability and efficacy of integrating the BeyondNow suicide prevention smartphone app into a telephone support service for callers who are experiencing suicidal thoughts.
Secondary ID [1] 291454 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation and behaviours 302500 0
Condition category
Condition code
Mental Health 302056 302056 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Callers to a telephone support service, who present with mild to moderate suicidal ideation, will be given the option of creating a personalised safety plan using the 'BeyondNow' smartphone app. Support service counsellors will guide callers through the app installation process over the phone. The counsellors will then spend 10 - 15 minutes assisting callers to develop a safety plan and teaching them how to use the app during the initial phone call. The BeyondNow app provides users with the ability to develop a structured, and personally useful list of coping and help-seeking strategies which can be used to help cope with suicidal ideation during times of distress or crisis. The app allows users to document personalised warning signs of an impending crisis, ways to keep their environment safe, reasons for living, coping and distraction strategies, socialisation strategies, social contacts and professional support services. Callers who consent to participate in the research study, agree to use the BeyondNow app at their discretion for 6-weeks following contact with the telephone support service. Naturalistic use of the app will be monitored. All telephone support service counsellors hold a tertiary degree in a relevant dscipline, or are registered nurses that have a minimum of ten-years experience in mental health nursing. Counsellors also have at least three months relevant counselling experience, have knowledge of depression, anxiety and associated issues, and have received training from the researchers on safety planning and use of the BeyondNow app.
Intervention code [1] 297510 0
Behaviour
Intervention code [2] 297511 0
Prevention
Intervention code [3] 297512 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301476 0
Telephone support service counsellor opinions regarding the integration of the BeyondNow app into support service call. Counsellor opinions will be gathered via a brief (1-minute) survey following each call using a survey designed specifically for this study. A qualitative interview designed specifically for this study will be used to gather counsellors' overall impressions at the end of the trial.
Timepoint [1] 301476 0
The brief (1-minute) survey will be completed following each call in which the BeyondNow was offered to a caller. The qualitative interview will be conducted at the end of trial, following cessation of recruitment.
Primary outcome [2] 301663 0
Telephone support service caller opinions regarding the integration of BeyondNow app into phone support service call. Caller opinions will be gathered via qualitative interview designed specifically for this study.
Timepoint [2] 301663 0
Measured at baseline assessment by researchers, which will occur within three days of contact with the telephone support service.
Primary outcome [3] 301664 0
Participant self-report ratings of confidence in coping with suicidal ideation (Suicide Related Coping Scale).
Timepoint [3] 301664 0
Baseline and 6-weeks.
Secondary outcome [1] 332788 0
Participant self-report ratings of suicidal ideation (Columbia Suicide Severity Rating Scale - Brief version),
Timepoint [1] 332788 0
Baseline, 2-weeks, 4-weeks, and 6-weeks.
Secondary outcome [2] 333353 0
App usage - measured via electronic app usage data,


Timepoint [2] 333353 0
Captured daily from baseline to end of intervention (6-weeks).
Secondary outcome [3] 333480 0
Hopelessness - Measured using Beck Hopelessness Scale (4-item)
Timepoint [3] 333480 0
Baseline and 6-weeks.
Secondary outcome [4] 333481 0
Perceived burdensomeness: Measured using Interpersonal Needs Questionnaire (10-item).
Timepoint [4] 333481 0
Baseline and 6 weeks.
Secondary outcome [5] 333482 0
Thwarted belongingness: Measured using Interpersonal Needs Questionnaire (10-item).
Timepoint [5] 333482 0
Baseline and 6 weeks.
Secondary outcome [6] 333483 0
Emotional and Physical pain: Measured using a 4-item rating scale designed specifically for this study.
Timepoint [6] 333483 0
Baseline, 2-weeks, 4-weeks, and 6 weeks.

Eligibility
Key inclusion criteria
Mild to moderate suicidal ideation in past 2-weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals deemed to be at immediate risk of suicide such that safety planning is contraindicated.
Individuals who do not posses a compatible smartphone.
Intellectual disability.
Presence of marked psychotic symptoms.
Impairment limiting app usage (e.g. Language, sight)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative analysis for app user / counsellor opinion.
Random effects regression models for change in outcome variables (Confidence in coping with suicidal thoughts; Suicidal ideation) from baseline to end of trial.
Moderation analysis for app use (dose effect) on change in outcome variables from baseline to end of trial.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
17/04/2017
Actual
16/05/2017
Date of last participant enrolment
Anticipated
2/10/2017
Actual
12/07/2017
Date of last data collection
Anticipated
18/12/2017
Actual
Sample size
Target
40
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295924 0
Charities/Societies/Foundations
Name [1] 295924 0
The Movember Foundation
Country [1] 295924 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 294795 0
None
Name [1] 294795 0
Address [1] 294795 0
Country [1] 294795 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297201 0
Monash Univeristy Human Research Ethics Committee
Ethics committee address [1] 297201 0
Monash Research Office
26 Sports Walk
Monash University
Wellington Road
Clayton
VIC, 3168
Ethics committee country [1] 297201 0
Australia
Date submitted for ethics approval [1] 297201 0
23/11/2016
Approval date [1] 297201 0
06/01/2017
Ethics approval number [1] 297201 0
2017-1510-8486

Summary
Brief summary
Smartphone apps are an effective way to provide health services to the community. The current study will investigate the viability and efficacy of integrating the BeyondNow suicide prevention smartphone app into a telephone support service for callers who are experiencing suicidal thoughts. Participants will install and set up their safety plan using the BeyondNow app with a telephone support service counsellor. The app will remain installed on participants' phones for the subsequent 6-weeks. Opinions on the integration of the BeyondNow app into the telephone support service will be collected. How the participants use their apps, as well as measures related to suicide (suicide coping, hopelessness, perceived burdensomeness, and emotional and physical pain) will also be collected over the 6-week trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73326 0
Dr Glenn Melvin
Address 73326 0
Monash University Centre for Developmental Psychiatry & Psychology
Building #1
270 Ferntree Gully Road
Notting Hill
VIC 3168
Country 73326 0
Australia
Phone 73326 0
+613 9902 4562
Fax 73326 0
Email 73326 0
[email protected]
Contact person for public queries
Name 73327 0
Dr Daniel Gresham
Address 73327 0
Monash University Centre for Developmental Psychiatry & Psychology
Building #1
270 Ferntree Gully Road
Notting Hill
VIC 3168
Country 73327 0
Australia
Phone 73327 0
+613 9905 0163
Fax 73327 0
Email 73327 0
[email protected]
Contact person for scientific queries
Name 73328 0
Dr Glenn Melvin
Address 73328 0
Monash University Centre for Developmental Psychiatry & Psychology
Building #1
270 Ferntree Gully Road
Notting Hill
VIC 3168
Country 73328 0
Australia
Phone 73328 0
+613 9902 4562
Fax 73328 0
Email 73328 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.