Contact information
Type
Scientific
Primary contact
Dr Craig Steel
ORCID ID
Contact details
Department of Psychology
Whiteknights Campus
University of Reading
Reading
RG6 6AL
United Kingdom
0118 378 7550
c.steel@reading.ac.uk
Type
Public
Additional contact
Dr Craig Steel
ORCID ID
Contact details
Department of Psychology
Whiteknights Campus
University of Reading
Reading
RG6 6AL
United Kingdom
0118 378 7550
c.steel@reading.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Making sense of voices: a case series
Acronym
Study hypothesis
The main hypothesis to be tested is whether the Making Sense of Voices intervention will reduce the level of distress associated with the experience of hearing voices.
Ethics approval
NRES South Central Berkshire B, ref: 15/SC/0013
Study design
The study design is a multiple baseline case series design with a randomised duration of waitlist.
Primary study design
Interventional
Secondary study design
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Hearing voices
Intervention
1. Phase 1: Assessment and construct:
The Maastricht Hearing Voices Interview: This is a clinical interview. For most voice hearers, the interview is part of an intervention as the conversation challenges cognitive avoidance of the topic.
The construct: The construct relates voices to the personal history of the voice hearing individual. Voice hearers acquire insight in the assumed original mechanisms of their voices. The individuals who represent the voices and the problems that the voices represent are identified. Making a construct is comparable with constructing a functional analysis as is done in behavioral therapy.
2. Phase 2: Intervention:
The intervention is aimed at reducing distress, and improving the quality of the relationship between voice hearer and her/his voices. Often voice hearers experience an unequal relationship with their voices, where the voices dominate in a negative way and are responsible for disturbing daily functioning.
To improve the relationship with the voices 3 types of methods are used:
2.1. Homework assignments: to communicate with the voices at a set time during each day.
2.2. Role play: to exercise how to communicate with the voices in the session
2.3. Talking with the voices: the therapist communicates indirectly or directly with the voices.
The communication with the voices is guided by the assumption that voice hearing is traumatic in origin and that the voices are signals to protect certain vulnerabilities. Many voice hearers experience their voices as attacking self esteem and self-efficacy; by this intervention the communication is bent towards voices as ‘allies’, from a destructive towards a constructive relationship.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Hallucination Change Scale (HCS). Each participant generates a narrative description of their auditory hallucinations (AH) scored for the 24-hour time period just prior to initiation of the trial, which was scored as a 10. The Hallucination Change Scale (HCS) is scored in subsequent assessments by requesting the patient to generate a new narrative description of AHs. Follow-up severity scores ranged from 0, corresponding to no hallucinations, to a maximum score of 20, corresponding to hallucinations twice as severe as baseline.
Secondary outcome measures
1. Voice hearing:
1.1. Psychotic Symptoms Rating Scale (PSYRATS (AH)): 11 items completed on the basis of a clinical interview, and enables analysis in relation to voice distress specifically as well as a wider range of voice characteristics
1.2. Positive and Negative Symptom Scale (PANNS): A widely used clinical interview assessing a wide range of symptoms associated with a diagnosis of a psychotic disorder
1.3. Beliefs about Voices Scale (BAVQ-R). A 35-item self-report measure of the appraisals made in relation to a voice hearing experience
1.4. The Voice and You Rating Scale (VAY). A 28-item self-report measure assessing the relationship an individual has with their voices
1.5. The DAIMON Scale. A 28-item self-report measure assessing how an individual relates to a voice hearing experience
2. Anxiety and Depression:
2.1. Generalised Anxiety Disorder (GAD7). A 7-item self-report anxiety measure
2.2. Physical Health Questionnaire (GAD9). A 9-item self-report measure of depression
3. Dissociation:
3.1. Dissociative Experience Scale (DES). 28-item self-report measure
4. Wellbeing
4.1. Warwick Edinburgh Mental Wellbeing Scale (WEMWB) - 14 item self-report measure
4.2. Self Compassion Scale (SCS) – a 12 item self-report measure
Overall trial start date
01/05/2015
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Participants will be eligible if they:
1. Report currently distressing voices as determined by a rating of 2 or above on the ‘Intensity of Distress’ item on the PSYRATS scale
2. Has had recorded contact and treatment from mental health services at the point of recruitment
3. Aged 18-65
4. No significant history of organic, or drug/alcohol factors implicated in the aetiology of psychotic symptoms
5. English speaking
6. Provides informed patient consent
7. Not receiving care from a learning disability service
8. Has a fixed abode. Having a fixed abode is operationalised as having a current address (including B&B or open access hostel) and evidence (e.g. from key worker) indicating that the person is more likely than not to have a reliable address throughout the 2 years. Although the exclusion of those with no fixed abode may limit the sample, this is a necessary restriction to avoid inevitable sample attrition from this group
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
1. Unable to provide informed consent
2. Unable to communicate sufficiently in English
3. Of no fixed abode
Recruitment start date
01/05/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Berkshire Healthcare Foundation Trust
Fitzwilliam House
Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom
Sponsor information
Organisation
Berkshire Healthcare Foundation Trust
Sponsor details
Berkshire Healthcare NHS Foundation Trust
Fitzwilliam House
Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom
01344 415825
stephen.zingwe@berkshire.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University of Reading
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary