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A pilot randomised controlled trial of guided self-help cognitive behaviour therapy for distressing voices

Guided self-help CBT intervention for voices Evaluated (GiVE): an external pilot randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77762753
Enrollment
30
Registered
2015-07-23
Start date
2015-09-01
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

The intervention being trialed is specifically for people who hear distress voices (also know as auditory hallucinations). This may be in the context of a psychosis or another mental health problem. Mental and Behavioural Disorders Auditory hallucinations

Interventions

The intervention in this trial is guided self-help using cognitive behavioural techniques. The intervention using the self-help book 'Overcoming Distressing Voices' by Hayward, Strauss and Kingdon (2

Sponsors

University of Sussex (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Currently distressed by hearing voices (as defined by scoring at least 3 on questions 5, 6 or 7 on the HPSVQ) 3. Experienced distressing voices for the preceding one year period 4. Be able to understand and communicate in English i.e. have the reading and writing ability of an 11 year old

Exclusion criteria

Exclusion criteria: Participants must not: 1. Have an organic illness 2. A current primary diagnosis of substance misuse 3. Be currently receiving or have confirmed plans to begin a psychological therapy for any mental health problem

Design outcomes

Primary

MeasureTime frame
Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) distress subscale. The HPSVQ is a self-report questionnaire. This outcome will be measured at baseline (before randomisation) and at 12 weeks (post therapy for those in the intervention group).

Secondary

MeasureTime frame
1. Visual Analogue Scales (VAS) measuring beliefs about personal control when voices are active, beliefs about the self, assertiveness, and ability to cope with voices. This measure will be used to track changes in what are hypothesised to be the mechanisms of change and to see if these correspond with the topics of the therapy sessions i.e. do beliefs about the self improve after the self module of therapy 2. The Hospital Anxiety and Depression Scale (HADS) . The changes in distress related to the voice hearing experience that is hypothesised may actually reflect a more global reduction in distress – therefore this measure will allow us to capture this. 3. Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). A measure of well-being will give us a more global assessment of how the participants believe their mental health currently is and if this has changed at all 4. Choice of Outcome In Cbt for psychosES (CHOICE) . It is important for this study to include a measure that reflects the outcomes that are important to patients; the CHOICE was developed in partnership with service users and therefore meets this criteria 5. The Brief Core Schema Scale (BCSS) self scale . One of the modules within the therapy focuses on beliefs about the self; this measure gives an assessment as to the degree of positive and negative beliefs the person has about themselves 6. Voice and You (VAY). One of the modules within the therapy looks at relationships, both socially and relationships with the voice; this measure gives an assessment of the nature of the relationship between the voice and hearer, and can measure any changes that might occur in relation to this 7. Beliefs about voices questionnaire- revised (BAVQ-R). One of the modules within the therapy targets beliefs about voices; the present measure is able to measure the degree to which these beliefs are positive or negative,

Countries

United Kingdom

Contacts

Public ContactCassie Hazell
ch283@sussex.ac.uk+44 (0)1273 678570

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026