Relating Therapy for voices: Evaluating a relationally-based therapy for people who hear distressing voices
| ISRCTN | ISRCTN44114663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44114663 |
| Secondary identifying numbers | 14628 |
- 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
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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. Assessment data at Time 0 (baseline) will be collected pre-randomisation by a research assistant. Assessments at Times 1 (post-therapy) and 2 (3-month follow-up) will be collected by a research assistant who is blind to allocation. |
| Secondary outcome measures | 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). 2. Voice and You (VAY) - the VAY is a 28-item measure of interrelating between the hearer and their predominant voice (Hayward et al, 2008). Relating is measured across four scales; two concerning the hearer's perception of the relating of the voice - voice dominance and voice intrusiveness; and two concerning the relating of the hearer - hearer distance and hearer dependence. Each item is measured on a four-point scale (0-3) generating the following range of scores for each scale: Voice Dominance 0-21; Voice Intrusiveness 0-15; Hearer Distance 0-21; and Hearer Dependence 0-27. The VAY has good internal consistency (α > .80 for all scales) and acceptable test-retest reliability (r > .7 for all scales). 3. Persons Relating to Others Questionnaire (PROQ3) - the PROQ3 is a 40 item questionnaire that assesses relating across eight scales which correspond to the relating positions within Birtchnell's Interpersonal Octogan . Response options are `Nearly always true', `Quite often true', `Sometimes true' and `Rarely true', which carry a score of 3, 2, 1 or 0. Thus each scale has a score range of 0 -15, and there is a maximum total score of 120 (Birtchnell et al, in press). 4. Hospital anxiety and depression scale (HADS) the HADS is a 16 item measure of symptoms of anxiety and depression that has well established psychometric properties (Zigmund & Snaith,1983). Assessment data at Time 0 (baseline) will be collected pre-randomisation by a research assistant. Assessments at Times 1 (post-therapy) and 2 (3-month follow-up) will be collected by a research assistant who is blind to allocation. |
| Overall study start date | 04/06/2013 |
| Completion date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 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
- England
- United Kingdom
Study participating centre
BN3 7HZ
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Tanya Telling, R&D Manager
Sussex Education Centre
Nevill View Hospital
Hove
BN3 7HZ
England
United Kingdom
| Phone | +44 (0)127 326 5909 |
|---|---|
| tanya.telling@sussexpartnership.nhs.uk | |
| Website | http://www.sussexpartnership.nhs.uk/ |
"ROR" |
https://ror.org/05fmrjg27 |
Funders
Funder type
Other
No information available
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 | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/08/2014 | Yes | No | |
| Results article | results | 01/05/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/10/2018: Publication reference added.
