Making sense of voices

ISRCTN	ISRCTN54370851
DOI	https://doi.org/10.1186/ISRCTN54370851
Secondary identifying numbers	N/A

Submission date: 26/06/2015
Registration date: 08/07/2015
Last edited: 26/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Plain English summary under review

Contact information

Dr Craig Steel
Scientific

Department of Psychology
Whiteknights Campus
University of Reading
Reading
RG6 6AL
United Kingdom

Phone	0118 378 7550
Email	c.steel@reading.ac.uk

Dr Craig Steel
Public

Department of Psychology
Whiteknights Campus
University of Reading
Reading
RG6 6AL
United Kingdom

Phone	0118 378 7550
Email	c.steel@reading.ac.uk

Study information

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
Study setting(s)	Community
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Making sense of voices: a case series
Study objectives	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(s)	NRES South Central Berkshire B, ref: 15/SC/0013
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2015
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	15
Total final enrolment	15
Key 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
Key exclusion criteria	1. Unable to provide informed consent 2. Unable to communicate sufficiently in English 3. Of no fixed abode
Date of first enrolment	01/05/2015
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Berkshire Healthcare Foundation Trust

Fitzwilliam House
Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom

Sponsor information

Berkshire Healthcare Foundation Trust
Hospital/treatment centre

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

Phone	01344 415825
Email	stephen.zingwe@berkshire.nhs.uk
"ROR"	https://ror.org/03t542436

Funders

Funder type

University/education

University of Reading
Private sector organisation / Universities (academic only)

Alternative name(s): UoR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/01/2019	26/06/2020	Yes	No
HRA research summary			28/06/2023	No	No

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.