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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

27/10/2021

Date data sharing statement initially provided

19/12/2018

Date results provided

27/10/2021

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]

None

Universal Trial Number (UTN)

Trial acronym

SAVVy

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hearing Voices

Auditory hallucinations

Psychotic Disorders

Mental Disorders

Condition category

Condition code

Mental Health

Psychosis and personality disorders

Mental Health

Schizophrenia

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

Recorded throughout the intervention (all treatment group only, except for study recruitment and retention rates)

Primary outcome [2]

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]

Following completion of the intervention - treatment group only

Primary outcome [3]

Psychotic Symptom Rating Scales - Auditory Hallucinations (PSYRATS-AH) - Total Score

Timepoint [3]

Baseline, 8 weeks following baseline

Secondary outcome [1]

Subjective Experience of Psychosis Scale (SEPS) – Negative Impact Subscale

Timepoint [1]

Baseline, 8 weeks following baseline

Secondary outcome [2]

Depression, Anxiety Stress Scale-21 (DASS-21)

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/03/2017

Actual

16/03/2017

Date of last participant enrolment

Anticipated

15/03/2018

Actual

31/01/2018

Date of last data collection

Anticipated

15/05/2018

Actual

11/04/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Alfred Psychiatry Research Centre - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Barbara Dicker Brain Sciences Foundation

Address [1]

John St, Hawthorn VIC 3122

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Australian Government Research Training Program Scholarship

Address [2]

50 Marcus Clarke St, Canberra ACT 2601

Country [2]

Australia

Primary sponsor type

University

Name

Swinburne University of Technology

Address

John St, Hawthorn VIC 3122

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred HREC

Ethics committee address [1]

Office of Research and Governance, The Alfred. Commercial Road, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/08/2016

Approval date [1]

12/10/2016

Ethics approval number [1]

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

A/Prof Neil Thomas

Address

ATC921, Brain and Psychological Sciences Research Centre (H99), Swinburne University of Technology, John Street, Hawthorn VIC 3211

Country

Australia

Phone

+61 3 9214 8742

Fax

[email protected]

Contact person for public queries

Name

Imogen Bell

Address

BA504, Brain and Psychological Sciences Research Centre, Swinburne University of Technology, John Street, Hawthorn VIC 3211

Country

Australia

Phone

+61 3 9214 5372

Fax

[email protected]

Contact person for scientific queries

Name

Imogen Bell

Address

BA504, Brain and Psychological Sciences Research Centre, Swinburne University of Technology, John Street, Hawthorn VIC 3211

Country

Australia

Phone

+61 3 9214 5372

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• This will be determined on a case-by-case basis by the Principal Investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?

• Data shared will be determined on a case-by-case basis by the Principal Investigator.

What types of analyses could be done with individual participant data?

• This will be determined on a case-by-case basis by the Principal Investigator.

When can requests for individual participant data be made (start and end dates)?

From:
Following the publication of the trial outcomes, which is to be determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• This will be determined on a case-by-case basis by the Principal Investigator.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
818	Study protocol				https://trialsjournal.biomedcentral.com/articles/1... [More Details]

Results publications and other study-related documents

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No additional documents have been identified.

Trial Review

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