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Trial registered on ANZCTR


Registration number
ACTRN12617000348358
Ethics application status
Approved
Date submitted
4/03/2017
Date registered
7/03/2017
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Date results information initially provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a novel smartphone-assisted coping focused intervention for people who experience distressing voices (SAVVy)
Scientific title
Evaluating a novel smartphone-assisted coping focused intervention for people who experience distressing voices (SAVVy)
Secondary ID [1] 290317 0
None
Universal Trial Number (UTN)
Trial acronym
SAVVy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Voices 300580 0
Auditory hallucinations 300581 0
Psychotic Disorders 300582 0
Mental Disorders 300583 0
Condition category
Condition code
Mental Health 300432 300432 0 0
Psychosis and personality disorders
Mental Health 300433 300433 0 0
Schizophrenia
Mental Health 300434 300434 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychological intervention focusing on improving self-management of distressing voice hearing experiences (‘auditory hallucinations’). The intervention will involve receiving four, one hour, individual (one-to-one) sessions with a trained therapist spaced 7-14 days apart. The first session will involve psychoeducation regarding voice hearing experiences and exploration of the participant’s own experiences, discussing factors which influence their voices day-to-day, and training in how to use the smartphone app. Between the first and second session, participants will answer multiple questionnaires via a smartphone app which records momentary voice hearing experiences and related variables such as mood and various responses to the voices (‘ecological momentary assessment’). Data recorded by the smartphone will then be analysed by the research team to identify potential within-person variables which influence fluctuations in the participant’s voices. This is then presented as feedback to participants in the second session (if such variables are detected by the data), which is then discussed in context of a basic functional model of antecedents and responses to voices. From this, coping strategies which may be helpful given this model are identified collaboratively. These coping strategies are then coded in to the app such that the smartphone sends reminders to participants of these strategies in daily life (‘ecological momentary intervention’). Session 3 and 4 involve reviewing these coping strategies and discussing feedback from the app regarding their use and helpfulness. The smartphone app automatically records when the participant uses the app in order to monitor adherence and engagement. The treatment group will receive the intervention alongside their usual treatment by their regular mental health providers (treatment-as-usual, TAU) which will continue without restriction from involvement in the trial. This will be delivered in the 2-month period immediately following randomisation. The intervention sessions will be conducted at a specialist clinic for people who experience persisting voices. A therapy manual specifically designed for this study will be followed by all therapists and fidelity to this protocol will be assessed using measures following each session.
Intervention code [1] 296129 0
Behaviour
Intervention code [2] 297407 0
Treatment: Other
Intervention code [3] 297408 0
Treatment: Devices
Comparator / control treatment
The comparison condition will involve receipt of the person’s usual treatment by their regular mental health provider (TAU) alone, without restriction from involvement in the trial. TAU will typically involve prescription of antipsychotic medication, plus meetings with mental health workers and possible attendance at rehabilitative and recovery-oriented mental health service programs. Participants are allowed to continue receiving other psychological treatment during the study. Use of mental health services (including psychological treatment and antipsychotic medication prescribing) will be tracked in both conditions and chlorpromazine-equivalent dosages controlled for in analyses if needed.
Control group
Active

Outcomes
Primary outcome [1] 299871 0
Feasibility: level of engagement with intervention sessions rated by the therapist following each session; number of times the EMI coping strategy reminders are viewed; response rates to EMA items; fidelity to intervention protocol rated by the therapist following each session; study recruitment and retention rates
Timepoint [1] 299871 0
Recorded throughout the intervention (all treatment group only, except for study recruitment and retention rates)
Primary outcome [2] 299872 0
Acceptability of different components of SAVVy intervention (one-to-one sessions, smarpthone app, feedback): quantitative acceptability measure designed specifically for this study; qualitative interview designed specifically for this study
Timepoint [2] 299872 0
Following completion of the intervention - treatment group only
Primary outcome [3] 300914 0
Psychotic Symptom Rating Scales - Auditory Hallucinations (PSYRATS-AH) - Total Score
Timepoint [3] 300914 0
Baseline, 8 weeks following baseline
Secondary outcome [1] 328351 0
Subjective Experience of Psychosis Scale (SEPS) – Negative Impact Subscale
Timepoint [1] 328351 0
Baseline, 8 weeks following baseline
Secondary outcome [2] 328352 0
Depression, Anxiety Stress Scale-21 (DASS-21)
Timepoint [2] 328352 0
Baseline, 8 weeks following baseline

Eligibility
Key inclusion criteria
1. Over the age of 18
2. Sufficient conversational English for meaningful participation in the study
3. Current persisting auditory verbal hallucinations defined by, over the week preceding the baseline assessment, hearing a hallucinated voice or voices on at least four different occasions, AND/OR on one or more occasion and lasting for at least an hour (score of 3 or more on PSYRATS-AH item 2)
4. Experiencing distress due to the voices (score of 1 or more on PSYRATS-AH item 8)
5. Experiencing auditory verbal hallucinations for at least 6 months
6. Willing to use the smartphone app during the trial
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide informed consent
2. Intellectual disability (Wechsler Test of Adult Reading estimated IQ < 70)
3. Voices occur solely in the context of substance use
4. Initiation of a new antipsychotic medication within the previous eight weeks
5. Too distressed or agitated to take part in the study
6. Current risk of harm to self or others that requires active crisis management

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation made independently of the research team via email
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised minimisation allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6827 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 14489 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 294711 0
Charities/Societies/Foundations
Name [1] 294711 0
Barbara Dicker Brain Sciences Foundation
Address [1] 294711 0
John St, Hawthorn VIC 3122
Country [1] 294711 0
Australia
Funding source category [2] 295829 0
Government body
Name [2] 295829 0
Australian Government Research Training Program Scholarship
Address [2] 295829 0
50 Marcus Clarke St, Canberra ACT 2601
Country [2] 295829 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John St, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 294677 0
None
Name [1] 294677 0
Address [1] 294677 0
Country [1] 294677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296133 0
Alfred HREC
Ethics committee address [1] 296133 0
Office of Research and Governance, The Alfred. Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 296133 0
Australia
Date submitted for ethics approval [1] 296133 0
31/08/2016
Approval date [1] 296133 0
12/10/2016
Ethics approval number [1] 296133 0
440/16

Summary
Brief summary
Hearing voices are a phenomenon experienced in a number of mental disorders, especially schizophrenia, mood disorders and trauma-related disorders. Voice hearing can be persistent for many, resulting in a potentially distressing and disabling experience. Existing psychological treatments are effective for some, but costly to deliver, and require specialist expertise that is not widely available. New interventions have been called for that are simpler and more targeted, and which empower people to self-manage their own experiences. Such interventions may be enhanced by recent developments in e-mental health, particularly the use of smartphone technology. These technologies can increase accessibility, reduce costs, and promote autonomous recovery.

An important development in e-mental health is the use of ecological momentary assessment (EMA) and intervention (EMI) in the context of treatment. EMA utilises mobile devices to collect multiple recordings of momentary experiences through self-monitoring in the context of the person’s daily life. This can provide individualised feedback on how symptoms evolve in real time in relation to the person’s environment, psychological processes, and how the person responds to them. EMI extends the use of smartphones to delivery of reminders and symptom self-management instructions during daily life.

The aim of this work is to develop and evaluate a new intervention which unifies the unique monitoring capabilities of EMA with the momentary intervention capabilities of EMI in a coping-focused intervention for distressing voices (SAVVy: Smartphone-Assisted coping focused interVention for Voices). The second aim is to investigate variables which influence fluctuations in voice hearing experiences in daily life using EMA, in addition to increasing understanding of the nature and use of coping strategies in the daily life of voice hearers.

The design of the current study is a randomised controlled trial (RCT) comparing a group of participants who will complete the SAVVy intervention whilst receiving regular treatment (17 participants), with a group only receiving regular treatment (17 participants). The intervention will involve receiving four, one-to-one sessions with a therapist whilst completing smartphone-based EMA and EMI between sessions. Information gathered during initial EMA monitoring of voice hearing experiences will be provided as feedback to participants during therapy and will inform the choice of specific coping strategies for self-managing the voices. The coping strategies will then be sent to participant via EMI reminders from the smartphone app between remaining sessions.

Assessments will be taken before the intervention and 8 weeks following randomisation (post assessment blinded). The primary focus of this trial is to establish feasibility and acceptability of the intervention, and a preliminary indication of efficacy.
Trial website
www.savvyresearchtrial.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69646 0
A/Prof Neil Thomas
Address 69646 0
ATC921, Brain and Psychological Sciences Research Centre (H99), Swinburne University of Technology, John Street, Hawthorn VIC 3211
Country 69646 0
Australia
Phone 69646 0
+61 3 9214 8742
Fax 69646 0
Email 69646 0
neilthomas@swin.edu.au
Contact person for public queries
Name 69647 0
Ms Imogen Bell
Address 69647 0
BA504, Brain and Psychological Sciences Research Centre, Swinburne University of Technology, John Street, Hawthorn VIC 3211
Country 69647 0
Australia
Phone 69647 0
+61 3 9214 5372
Fax 69647 0
Email 69647 0
ibell@swin.edu.au
Contact person for scientific queries
Name 69648 0
Ms Imogen Bell
Address 69648 0
BA504, Brain and Psychological Sciences Research Centre, Swinburne University of Technology, John Street, Hawthorn VIC 3211
Country 69648 0
Australia
Phone 69648 0
+61 3 9214 5372
Fax 69648 0
Email 69648 0
ibell@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data shared will be determined on a case-by-case basis by the Principal Investigator.
When will data be available (start and end dates)?
Following the publication of the trial outcomes, which is to be determined.
Available to whom?
This will be determined on a case-by-case basis by the Principal Investigator.
Available for what types of analyses?
This will be determined on a case-by-case basis by the Principal Investigator.
How or where can data be obtained?
This will be determined on a case-by-case basis by the Principal Investigator.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 818 0
Study protocol
Citation [1] 818 0
Link [1] 818 0
Email [1] 818 0
Other [1] 818 0
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2607-6
Attachment [1] 818 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary