Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Plain English summary under review

Trial website

Contact information



Primary contact

Dr Craig Steel


Contact details

Department of Psychology
Whiteknights Campus
University of Reading
United Kingdom
0118 378 7550



Additional contact

Dr Craig Steel


Contact details

Department of Psychology
Whiteknights Campus
University of Reading
United Kingdom
0118 378 7550

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Making sense of voices: a case series


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


Secondary study design

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Hearing voices


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



Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Unable to provide informed consent
2. Unable to communicate sufficiently in English
3. Of no fixed abode

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Berkshire Healthcare Foundation Trust
Fitzwilliam House Skimped Hill Lane
RG12 1BQ
United Kingdom

Sponsor information


Berkshire Healthcare Foundation Trust

Sponsor details

Berkshire Healthcare NHS Foundation Trust
Fitzwilliam House
Skimped Hill Lane
RG12 1BQ
United Kingdom
01344 415825

Sponsor type

Hospital/treatment centre



Funder type


Funder name

University of Reading

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)


United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2019 results in (added 26/06/2020)

Publication citations

Additional files

Editorial Notes

26/06/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added.