Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001499471
Ethics application status
Approved
Date submitted
25/10/2016
Date registered
28/10/2016
Date last updated
3/06/2021
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
3/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial measuring a new clinical psychology intervention on improving outcomes for people with schizophrenia and distressing voice hallucinations.
Scientific title
A single blind randomised controlled clinical trial testing the effectiveness of a clinical psychology intervention on improving the distress associated with auditory hallucinations in schizophrenia as measured by the Revised Beliefs About Voices Questionnaire.
Secondary ID [1] 290390 0
None
Universal Trial Number (UTN)
Trial acronym
VHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
schizophrenia 300711 0
Condition category
Condition code
Mental Health 300555 300555 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name and description of the investigational product – Clinical Psychology Intervention for Voice Hallucinations (CPV)

CPV is at least one 45 minute individual face to face session with a Clinical Psychologist on the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU), involving assessment and linking into community therapy with a clinical psychologist, during a 1 day admission on the SCGH MHU. The maximum time of a CPV is 1 hour 3 times week over a 12 month admission. How many sessions each participant attends is a collaborative decision between the participant, the clinical psychologist and the treating team based on the clinical needs of the patient and length of hospital stay. The clinical psychologist draws from the following three modules as required for each patient. The duration and number of sessions taken to complete each of the three modules is based on the individual needs of each participant and in collaboration with the clinical psychologist . The minimum duration would be 0 minutes during 1 assessment session of 45 minutes. The maximum would be 1 hour of each module per week for 12 months. This would be unusual. The first 3 modules are a description of how the clinical psychologist might spend the time with the patient on top of assessment and supporting the patient to obtain and negotiate a referral to a suitable clinical psychologist in the community.
Module 1 is called Coping with Voices and includes a discussion of the strengths and weaknesses of strategies already used; review of a strategy handout about healthy lifestyle techniques, keeping a balanced perspective, understanding your voices, distraction/interfering techniques and calming/soothing techniques; identification of up to 3 strategies willing to be tried after the group. Module 2 is called Coping with Voices and Self-esteem. It includes discussion of the definition of self esteem, how voice hallucination experience influences self-esteem, self-esteem enhancement, and acknowledgement of the participant's positive qualities. Module 3 is called Coping with Voices and Stigma. It includes discussion about participant and public attitudes to mental illness and psychotic spectrum disorders, experiences with stigma, education about common mental illness myths, coping strategies for discrimination and negative attitudes. Handouts from the first 3 modules are available to patients as appropriate
Adherence to the intervention is monitored by the SCGH MHU clinical psychologists who meet weekly for 1 hour of reflective practice. They will keep a record of the duration, number and date of sessions of an intervention for each patient on the Patient Information Form.
Intervention code [1] 296218 0
Treatment: Other
Comparator / control treatment
Treatment As Usual (TAU) occurs while the participant is on the SCGH MHU and post discharge during the length of the trial. It involves medication plus at least a 12 monthly medical check-up with a doctor and a minimum of one other treatment program attendance from the following list: Psychiatrist visit/visits other than the 12 month medical check-up doctor in treatment as usual; General practitioner visit/visits other than the 12 month medical check-up doctor in treatment as usual; Regular pickup of Webster medication packs at pharmacy; Hospital in the Home twice daily nurse visits for 2 weeks; Mental health nurse outreach support; Generic case manager outreach support; Supportive inpatient milieu as required; Inpatient or outpatient occupational therapy group program; Community rehabilitation program; Inpatient alcohol and drug program; Inpatient alcohol and drug brief information pack; Community alcohol and drug rehabilitation program; Nicotine addiction treatment; Drop in centre support; Sheltered work; Supported employment; Volunteer work; Education pathway with support; Education pathway without support; Family meetings; Other type of therapy; Non-government organisation outreach support; Non-government organisation social integration via recreational activities; Recreational group/s; Spiritual group; Regular exercise; Supported accommodation-Psychiatric hostel, group home, supported rental alone or shared, family home, aged care facility.
Control group
Active

Outcomes
Primary outcome [1] 299967 0
Revised Beliefs about Voices Questionnaire (BAVQ-R).
Timepoint [1] 299967 0
Baseline, post discharge, 1 ,3 and 6 months post discharge from the SCGH MHU
Secondary outcome [1] 328721 0
Psychotic Symptom Rating Scale (PSYRATS) hallucinations section
Timepoint [1] 328721 0
Baseline, post intervention,1, 3 and 6 months post discharge from the SCGH MHU
Secondary outcome [2] 328722 0
The Engagement in Community Therapy Questionnaire (ECTQ) will describe the type of community therapy engaged with and the number and dates of attendances.
Timepoint [2] 328722 0
In the past year at the pre-treatment baseline interview, and since last follow-up interview at discharge, 1, 3 and 6 months post discharge from the SCGH MHU.

Eligibility
Key inclusion criteria
Diagnosis of schizophrenia spectrum disorder defined by DSM-V; experiencing distressing voice hallucinations; has not previously received or is currently receiving CPV; voluntary or involuntary resident of SCGH Mental Health Unit Tanami ward; plans to reside in Australia for the duration of follow-ups; available for follow-up for at least 6 months; able to comply with requirements of the protocol; able and willing to understand and provide written informed consent; between 18 and 65 years of age.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Woman during the lactation period or pregnant; patient highly dependent on medical care; significant communication barrier.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size and power calculations:
Based on the paper by Leff et al. (2013), the corrected effect size is dCohen=0.438, 95% CI: -0.342 – 1.218. A power calculation was completed using G*Power, based on the paper by Faul et al. (2009),employing a power of 0.80, to detect a difference between the three groups with an alpha of 0.05, and an effect size of 0.438. Mixed Model Repeated Measures ANOVA requires 30 participants to maintain 0.80 power. In view of known attrition in longitudinal study designs, we make the conservative assumption that some 25% of participants may be lost to follow up after baseline contact, at 6 month follow-up we expect an additional 25% attrition. Therefore, 45 participants will be recruited to maintain appropriate study power.

Data Analysis:
Mixed models repeat measure ANOVAs will be conducted using SPSS v21. The dependent variables are total scores on the PSYRATS hallucinations section, BAVQ-R. The within-subjects factor is ‘time’ with measurements taken at pre-test, 1 month, 3 months, 6 months. The between-subjects factor is ‘intervention’, specifically, the two different treatments conditions 1) CPV + TAU and 2) TAU. Descriptive statistics for each group will also be reported.

References:
1.. Leff J, Williams G, Huchvale MA, Arbuthnot M, Leff AP. Computer-assisted therapy for medication-resistant auditory hallucinations: proof of concept study. The British Journal of Psychiatry 2013; 202: 428-433.
2. Faul F,Erdfelder E, Buchner A, Lang A-G. Statistical power and analyses using G* Power 3.1: Tests for correlation and regression analyses. Behaviour Research Methods 2009. 41: 1149-1160.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
19/12/2016
Actual
26/05/2017
Date of last participant enrolment
Anticipated
26/05/2021
Actual
25/03/2020
Date of last data collection
Anticipated
26/11/2021
Actual
26/09/2020
Sample size
Target
45
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6866 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 14536 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 294787 0
Government body
Name [1] 294787 0
North Metropolitan Health - Mental Health
Country [1] 294787 0
Australia
Primary sponsor type
Government body
Name
North Metropolitan Health Service -Adult Mental Health
Address
Private Bag 1PO
Claremont
Western Australia
6910
Country
Australia
Secondary sponsor category [1] 293631 0
None
Name [1] 293631 0
Address [1] 293631 0
Country [1] 293631 0
Other collaborator category [1] 279276 0
University
Name [1] 279276 0
University of Western Australia, School of Psychiatry
Address [1] 279276 0
Sir Charles Gairdner Hospital
D Block
Verdun Street
Nedlands
Western Australia
6009
Country [1] 279276 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296192 0
North Metropolitan Health Service - Mental Health Human Research Ethics Committee
Ethics committee address [1] 296192 0
Gascoyne House
Graylands campus
Locked Bag No 1
PO Claremont
Western Australia
6910
Ethics committee country [1] 296192 0
Australia
Date submitted for ethics approval [1] 296192 0
16/06/2016
Approval date [1] 296192 0
05/08/2016
Ethics approval number [1] 296192 0
01_2016

Summary
Brief summary
The trial aims to Demonstrate a Clinical Psychology Intervention for Voice Hallucinations (CPV) plus Treatment As Usual (TAU) is significantly superior to TAU in improving engagement with community therapy, by patient choice, in patients with distressing voice hallucinations and schizophrenia spectrum disorder at the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU). A secondary aim is to see if the distress associated with the voice hallucinations and the frequency and intensity of voice hallucinations will decrease with improved engagement in community therapy.

There are observed barriers to engagement with community therapy. The higher cost and effectiveness of CPV in overcoming these barriers, compared to the current standard TAU, needs justification by a comparative clinical trial.

The Participant group will be voluntary and involuntary residents of the SCGH MHU Tanami ward with schizophrenia spectrum disorder and distressing voice hallucinations who meet eligibility criteria.

The clinical trial design is a randomised single blind clinical trial comparing 2 treatments groups: CPV + TAU and TAU.

The outcomes measured will be change in: 1) Engagement in community therapy post discharge measured by the Engagement in Community Therapy Questionnaire (ECTQ). 2) Change in Patient’s distress associated with the voice hallucinations measured by the revised Beliefs About Voices questionnaire (BAVQ-R). 3) Frequency and intensity of voice hallucinations measured by the Psychotic Symptom Rating Scale (PSYRATS) hallucinations section. Measures will be collected at baseline, post discharge 1, 3 and 6 months post discharge by a blinded research officer.

The expected outcomes are that engagement in external community therapy will be significantly better in CPV + TAU than TAU at 1, 3, 6 months. Significant reductions in the total PSYRATS auditory hallucination score and abnormal beliefs about the voice hallucinations in the BAVQ-R score are expected at 6 months in the CPV + TAU group compared to the TAU group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69934 0
Dr Ann Solar
Address 69934 0
Sir Charles Gairdner Hospital Mental Health Unit
Verdun street
Nedlands
Western Australia
6009
Country 69934 0
Australia
Phone 69934 0
+61 8 63831000
Fax 69934 0
Email 69934 0
[email protected]
Contact person for public queries
Name 69935 0
Dr Ann Solar
Address 69935 0
Sir Charles Gairdner Hospital Mental Health Unit
Verdun street
Nedlands
Western Australia
6009
Country 69935 0
Australia
Phone 69935 0
+61 8 63831000
Fax 69935 0
Email 69935 0
[email protected]
Contact person for scientific queries
Name 69936 0
Dr Ann Solar
Address 69936 0
Sir Charles Gairdner Hospital Mental Health Unit
Verdun street
Nedlands
Western Australia
6009
Country 69936 0
Australia
Phone 69936 0
+61 8 63831000
Fax 69936 0
Email 69936 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.