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A clinical trial measuring a new clinical psychology intervention on improving outcomes for people with schizophrenia and distressing voice hallucinations.

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.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001499471
Acronym
VHT
Enrollment
36
Registered
2016-10-28
Start date
2017-05-26
Completion date
2020-03-25
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

North Metropolitan Health Service -Adult Mental Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Exclusion criteria

Woman during the lactation period or pregnant; patient highly dependent on medical care; significant communication barrier.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026