Relating Therapy for voices: Evaluating a relationally-based therapy for people who hear distressing voices
| ISRCTN | ISRCTN44114663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44114663 |
| Protocol serial number | 14628 |
| Sponsor | Sussex Partnership NHS Foundation Trust (UK) |
| Funder | British Academy - National Academy for the Humanities and Social Sciences (UK) Grant Codes: SG121682 |
- Submission date
- 17/06/2013
- Registration date
- 17/06/2013
- Last edited
- 05/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The experience of hearing voices is a defining feature of schizophrenia and is reported by 60% of service users. NHS guidance recommends that psychological therapy (Cognitive Behaviour Therapy for psychosis - CBTp) should be offered to all service users with a diagnosis of schizophrenia. However, the effect of CBTp specifically on voices is being questioned and a symptom-based approach may be warranted. An evolving body of literature is exploring the experience of hearing voices from interpersonal perspectives. Dr Hayward has developed and tested the feasibility of a therapy for distressing voices that is derived from this literature. This study aims to evaluate this relationally-based individual therapy for people hearing distressing voices.
Who can participate?
Male and female patients aged over 18 years who have been hearing treatment-resistant and distressing voices for at least one year.
What does the study involve?
The trial will compare outcomes for 15 service users receiving the therapy and their usual treatment with 15 service users receiving their usual treatment.
What are the possible benefits and risks of participating?
Not provided.
Where is the study run from?
Nevill View Hospital (UK).
When is the study starting and how long is it expected to run for?
The study will run from June 2013 to August 2014.
Who is funding the study?
The study is funded by the British Academy and Sussex Partnership NHS Foundation Trust.
Who is the main contact?
Dr Mark Hayward
mark.hayward@sussexpartnership.nhs.uk
Contact information
Scientific
Nevill View Hospital
Hove
BN3 7HZ
United Kingdom
| mark.hayward@sussexpartnership.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Relating Therapy for voices: A pilot randomised trial evaluating a relationally-based therapy for people who hear distressing voices |
| Study acronym | R2V |
| Study objectives | The primary aim of the study is to generate an effect size to inform the power calculation for a full randomised controlled trial (RCT). More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14628 Further reading: Hayward, M. (2003). Interpersonal relating and voice hearing: To what extent does relating to the voice reflect social relating? Psychology and Psychotherapy: Theory, Research and Practice, 76, 369-383. Hayward, M., Berry, K. & Ashton, A. (2011). Applying interpersonal theories to the understanding of and therapy for auditory hallucinations: A review of the literature and directions for further research. Clinical Psychology Review, 31, 1313-1323. Hayward, M., Denney, J., Vaughan, S. & Fowler, D. (2008). The Voice and You: Development and psychometric evaluation of a measure of relationships with voices. Clinical Psychology & Psychotherapy, 15, 45-52. Hayward, M., Overton, J., Dorey, T. & Denney, J. (2009). Relating Therapy for people who hear voices: a case series. Clinical Psychology & Psychotherapy, 16, 216-227. |
| Ethics approval(s) | NRES Committee South East Coast Surrey, 18/03/2013, ref: 12/LO/2045 |
| Health condition(s) or problem(s) studied | Topic: Mental Health Research Network; Subtopic: Schizophrenia, Psychosis; Disease: Schizophrenia, Psychosis |
| Intervention | Intervention = Relating Therapy offered in an individual format over a maximum of 16 sessions (+ treatment as usual) Control = treatment as usual Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Psychotic Symptoms Rating Scale (PSYRATS: Auditory hallucinations scale AHRS) - an 11-item rating scale designed to measure the severity of different dimensions of the voice hearing experience (Haddock et al, 1999). Items include frequency, duration, loudness, intensity of distress and controllability. Each item is measured by the rater on a 5-point scale ranging from 0-4. The items relating to intensity of distress and controllability of voices on the AHRS are the most often cited in the voice hearing literature and will be the focus of this study. |
| Key secondary outcome measure(s) |
1. CHOICE (Greenwood et al, 2009) - a 21 item self report questionnaire developed with service users to assess goals for CBT for psychosis that are relevant to recovery, e.g. self confidence, ways of dealing with unpleasant feelings and emotions, positive ways of relating to people, knowing I am not the only person who has unusual experiences, a positive purpose and direction in life. CHOICE has been found to be reliable and valid (Greenwood et al, 2009). |
| Completion date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Inclusion criteria will require that participants have been hearing treatment resistant and distressing voices for at least one year, irrespective of diagnosis. 2. Target Gender: Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | People will be excluded on the grounds of: 1. Organic illness 2. A primary diagnosis of substance misuse 3. Currently receiving psychological therapy for distressing voice |
| Date of first enrolment | 04/06/2013 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
BN3 7HZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2017 | Yes | No | |
| Protocol article | protocol | 16/08/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/10/2018: Publication reference added.