Online hearing voices peer support groups

ISRCTN	ISRCTN11873550
DOI	https://doi.org/10.1186/ISRCTN11873550
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	321293
Protocol serial number	NHS002041, IRAS 321293
Sponsor	University of Manchester
Funder	University of Manchester

Submission date: 24/01/2023
Registration date: 06/03/2023
Last edited: 06/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Hearing voices that nobody else can hear (auditory hallucinations) can be a distressing and isolating experience. Previous research has shown that meeting others with similar experiences can help people feel less isolated, cope better with their voice hearing experiences, and experience more hope for the future. While there are many peer support groups for voice hearers that meet face-to-face, many people cannot access these groups. The purpose of this study is to see if it is possible to run a peer support group for voice hearers online and if so, to start to explore how and why these groups may be beneficial. It is the hope that if these groups prove to be effective, they can be rolled out on a more wide-spread basis within the NHS.

Who can participate?
Six to ten adults who live in the UK and currently hear voices will be recruited to take part in the online hearing voices group. In order to participate, participants will need to have consistent access to the internet and the ability to use videoconferencing platforms (e.g. Zoom, MS Teams).

What does the study involve?
Participants will be recruited from secondary NHS mental health services, third-party mental health organisations, and the wider community. All study procedures will be completed online. Participants will be asked to join interviews and group meetings from a private, quiet location that is convenient to them. Participants will take part in a 1-to-1 interview and complete questionnaires about their voice hearing experiences before the online peer support group starts. The group will be facilitated by a peer facilitator with lived experience of voice hearing and a clinical psychologist from the NHS. The group will then meet once a week for 90 minutes for 6 months. In the group, participants can talk about their voices, explore how their voices make them feel, what their voices may be connected to, and learn new ways of understanding and coping with voices. At weeks 4 and 12, participants will be asked to complete a survey about their experiences in the group so far. At the end of the 6 months, participants will complete another interview, asking about their experiences within the group, and complete the same questionnaires.

What are the possible benefits and risks of participating?
It is hoped that participants will find partaking in the online peer support group beneficial, however this cannot be guaranteed. Data collected from research participants will be used to refine this intervention and hopefully enable it to become more widespread for other voice hearers in the future.

Given the sensitive nature of the research topic, it is possible that participants may become distressed during research interviews or during the online peer support group. In such an instance, participants will be reassured that they do not need to talk about anything more than they are comfortable with. Participants will also have the opportunity to talk to either the peer facilitator or clinical psychologist 1-on-1 should they become distressed during the group.

Disagreement is common and expected part of groups and it is possible that disagreement between group members may arise. Conflict will be addressed as openly and transparently as possible within the group.

Where is the study run from?
University of Manchester (UK)

When is the study starting and how long is it expected to run for?
July 2022 to July 2024

Who is funding the study?
University of Manchester (UK)

Who is the main contact?
Alison Branitsky, alison.branitsky@postgrad.manchester.ac.uk

Contact information

Ms Alison Branitsky
Public

Faculty of Biology, Medicine and Health, School of Health Sciences
Division of Psychology and Mental Health
2.43 Zochonis Building
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0002-7049-489X
Phone	+44 (0)7936813441
Email	alison.branitsky@postgrad.manchester.ac.uk

Dr Filippo Varese
Principal investigator

Faculty of Biology, Medicine and Health, School of Health Sciences
Division of Psychology and Mental Health
2.43 Zochonis Building
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0001-7244-598X
Phone	None provided
Email	Filippo.varese@manchester.ac.uk

Ms Alison Branitsky
Scientific

Faculty of Biology, Medicine and Health, School of Health Sciences
Division of Psychology and Mental Health
2.43 Zochonis Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)7936813441
Email	alison.branitsky@postgrad.manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Online non-randomized interventional trial
Secondary study design	Non randomised study
Participant information sheet	43099_PIS_v1.0_11Jan2023.pdf
Scientific title	Online hearing voices peer support groups: a feasibility and acceptability study
Study objectives	An online hearing voices peer support group for adults who hear voices will be feasible and acceptable
Ethics approval(s)	Approved 21/03/2023, West Midlands – Black Country Research Ethics Committee (Meeting held by video-conference via Zoom; +44 (0)207 104 8010, (0)207 104 8141; blackcountry.rec@hra.nhs.uk), ref: 23/WM/0045
Health condition(s) or problem(s) studied	Hearing voices (auditory verbal hallucinations)
Intervention	All participants enrolled in this study will participate in an online peer support group for voice hearers. The intervention is built on the principles of the Hearing Voices Network, which positions voice hearing as a meaningful and understandable psychological experience which is worth exploring. While peer support groups exist for voice hearers in the community, to date, no study has looked at the feasibility of running these types of groups online via videoconference. The peer support group will run for 6 months (26 sessions) and will meet weekly for 90 minutes over a videoconferencing platform (e.g., Zoom, MS Teams). The group will be facilitated by a peer facilitator with lived experience in voice hearing and a clinical psychologist. Group meeting details will be issued to all participants before the first group, and will remain the same for the entirety of the study. In the tradition of the Hearing Voices Network, the groups will remain largely unstructured, with participants encouraged to share whatever feels most relevant and important to them. However, within the group, there will be particular emphasis on exploring the phenomenology of voices, potential origins and understandings of voices, and developing new ways of coping with and relating to voices. Feasibility parameters (e.g., attendance) will be collected during each group meeting.
Intervention type	Behavioural
Primary outcome measure(s)	As this is a feasibility trial, a single primary outcome measure is not meaningful. However, key feasibility outcomes will be collected which will inform a definitive trial: 1. Referral and recruitment rates measured using study records at the end of the recruitment period in June 2023 2. Group attendance and outcome measure completeness rates measured using study records at the end of the study period in December 2023 3. Acceptability of the intervention assessed via drop-out rates and reason for withdrawal measured using study records at the end of the study period in 2023
Key secondary outcome measure(s)	1. Acceptability of the intervention and potential mechanisms of efficacy measured using qualitative interviews at baseline and end-of-study 2. Evaluations of social comparison measured using the Social Comparison Scale at baseline and end-of-treatment 3. Feelings of social connectedness and support measured using the Social Connectedness Scale-Revised (SCS-R) at baseline and end-of-study 4. Loneliness and social isolation measured using the UCLA Loneliness Scale at baseline and end-of-study 5. Personal beliefs about the self as a voice hearer measured using the Personal Beliefs about Experiences Questionnaire (PBEQ) at baseline and end-of-study 6. Assertive relating to voices and other people measured using the Approve-Voices and Approve-Social Questionnaires at baseline and end-of-study 7. The emotional impact of voice hearing measured using the Voice Impact Scale (VIS) at baseline and end-of-study 8. Acceptance of voices measured using the Voice Acceptance or Action Scale (VAAS-12) at baseline and end-of-study 9. Sense of personal recovery measured using the Questionnaire about the Process of Recovery-15 (QPR-15) at baseline and end-of-study 10. Feelings of cohesiveness within the group measured using the Group Cohesiveness Scale (GCS) at 4-weeks, 12-weeks, and end-of-study 11. Therapeutic factors within the group measured using the Therapeutic Factors Inventory-Short Form (TFI-S) at 4-weeks, 12-weeks and end-of-study
Completion date	28/07/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	10
Total final enrolment	9
Key inclusion criteria	1. Aged 18 years and over 2. Currently residing in the UK 3. Heard voices for at least 6 months 4. Able to provide informed consent 5. Willingness to engage in group support 6. Consistent access to the internet and ability to use videoconferencing platforms
Key exclusion criteria	1. At immediate risk of harm to self or others 2. Non-English speaking as assessment measures are only validated in English and in order for the support group to function, participants need to be able to communicate with one another
Date of first enrolment	04/04/2023
Date of final enrolment	05/10/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Greater Manchester Mental Health NHS Foundation Trust

Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Alison Branitsky (alison.branitsky@postgrad.manchester.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		04/02/2025	06/03/2025	Yes	No
HRA research summary			20/09/2023	No	No
Participant information sheet	version 1.0	11/01/2023	31/01/2023	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.0	11/01/2023	31/01/2023	No	No
Protocol file	version 2.0	17/01/2024	26/02/2024	No	No
Statistical Analysis Plan	version 1	29/03/2023	29/03/2023	No	No

Additional files

43099_PIS_v1.0_11Jan2023.pdf: Participant information sheet
43099_Protocol_v1.0_11Jan2023.pdf: Protocol file
ISRCTN11873550 SAP V1 29MAR2023.pdf: Statistical Analysis Plan
ISRCTN11873550_Protocol_V2.0_17Jan2024.pdf: Protocol file

Editorial Notes

06/03/2025: Publication reference added.
26/02/2024: Protocol (not peer reviewed) version 2.0 added.
18/10/2023: The recruitment end date was changed from 31/10/2023 to 05/10/2023. Total final enrolment added.
20/09/2023: A link to the HRA research summary was added.
18/09/2023: The recruitment end date was changed from 18/09/2023 to 31/10/2023.
16/08/2023: The recruitment end date was changed from 31/08/2023 to 18/09/2023.
22/06/2023: The recruitment end date was changed from 15/06/2023 to 31/08/2023.
02/05/2023: The sponsor contact details have been updated.
05/04/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 24/04/2023 to 04/04/2023.
2. The overall end date was changed from 28/02/2024 to 28/07/2024.
3. The plain English summary was updated to reflect these changes.
29/03/2023: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The ethics approval was added.
3. The recruitment start date was changed from 01/04/2023 to 24/04/2023.
15/03/2023: The recruitment start date was changed from 28/02/2023 to 01/04/2023.
31/01/2023: Trial's existence confirmed by the University of Manchester (UK).