ISRCTN - ISRCTN44114663: Relating Therapy for voices: Evaluating a relationally-based therapy for people who hear distressing voices

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Hayward

ORCID ID

Contact details

Nevill View Hospital
Hove
BN3 7HZ
United Kingdom
mark.hayward@sussexpartnership.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14628

Study information

Scientific title

Relating Therapy for voices: A pilot randomised trial evaluating a relationally-based therapy for people who hear distressing voices

Acronym

R2V

Study hypothesis

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

NRES Committee South East Coast Surrey, 18/03/2013, ref: 12/LO/2045

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

04/06/2013

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 30

Participant 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

Recruitment start date

04/06/2013

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nevill View Hospital
Hove
BN3 7HZ
United Kingdom

Sponsor information

Organisation

Sussex Partnership NHS Foundation Trust (UK)

Sponsor type

Hospital/treatment centre

Website

http://www.sussexpartnership.nhs.uk/

Funders

Funder type