The Feeling Heard study - evaluating a novel intervention pathway for patients distressed by hearing voices
| ISRCTN | ISRCTN16003237 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16003237 |
| IRAS number | 303466 |
| Secondary identifying numbers | CPMS 51307, IRAS 303466 |
- Submission date
- 21/02/2022
- Registration date
- 04/03/2022
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Cognitive Behaviour Therapy (CBT) has been the psychological intervention recommended for the ‘positive symptoms’ of psychosis (delusions and voice hearing) for the past two decades. However, CBT has experienced two barriers to progress during this time. Firstly, CBT has only been able to generate small-medium amounts of benefit (relative to control groups) for patients, and adaptations have been unable to break through the barrier. A recent response to this barrier has been to target CBT at one psychotic symptom at a time (the ‘single-symptom approach’) and results have been encouraging with enhanced benefits being reported. Secondly, there has been limited access to CBT with only a minority of patients being offered treatment. The reasons for limited access include a lack of resources as CBT is typically delivered by highly trained therapists who are in short supply. Our response to this barrier has been to evaluate CBT for distressing voices when offered by briefly trained therapists, with preliminary findings offering encouragement. Having made progress regarding both patient benefit from CBT and increased access to CBT, we now wish to combine these approaches to maximise access and benefits. Additionally, we want to offer patients greater choice over the length and content of CBT.
The long-term aim of this research is to increase access to effective psychological interventions for psychosis patients who are distressed by hearing voices.
The specific aim of the proposed study is to explore the feasibility and acceptability of offering choices within a pathway of brief and targeted interventions, delivered by a wider workforce of therapists.
Who can participate?
Adults over 18 years, with a diagnosis of psychosis and experiencing voice hearing.
What does the study involve?
Participants will have a baseline assessment and a pathway of interventions offered over a maximum of 20 sessions with monthly assessments.
What are the possible benefits and risks of participating?
Possible benefits - Participants will help us to learn if CBT interventions for distressing voices are more beneficial when delivered in a sequential manner. This will help mental health services to make decisions about the interventions that should be provided for people who hear distressing voices.
Possible risks - Talking about voice hearing experiences can be helpful, though it can also sometimes feel difficult or distressing. The therapists will be trained in helping people with distressing voices and will participants to cope with any temporary increases in distress, should this occur.
Where is the study run from?
Sussex Partnership NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2021 to August 2023
Who is funding the study?
Economic and Social Research Council (UK)
Who is the main contact?
Prof Mark Hayward, mark.hayward@spft.nhs.uk
Contact information
Scientific
Research & Development Department
Sussex Education Centre
Millview
Nevill Avenue
Hove
BN3 7HZ
United Kingdom
 ORCID ID |
0000-0001-6567-7723 |
|---|---|
| Phone | +44 300 304 0088 |
| mark.hayward@spft.nhs.uk |
Study information
| Study design | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | 41206 PIS v2 03Jan2022.pdf |
| Scientific title | Targeting distress reduction for patients experiencing distressing voices: A case series evaluating a novel intervention pathway (the Feeling Heard study) |
| Study acronym | Feeling Heard |
| Study hypothesis | The long-term aim of this research is to increase access to effective psychological interventions for psychosis patients who are distressed by hearing voices. The specific aim of the proposed study is to explore the feasibility and acceptability of offering choices within a pathway of brief and targeted interventions, delivered by a wider workforce of therapists. |
| Ethics approval(s) | Approved 11/01/2022, North West - Preston REC (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 2071048016; preston.rec@hra.nhs.uk), ref: 21/NW/0331 |
| Condition | Psychosis - voices |
| Intervention | ASSESSMENT PROCESS Assessments will be completed by participants, as follows: - baseline assessment - monthly assessments during treatment (maximum of 6) - post-treatment assessment All assessments will be conducted by a researcher either face-to-face or remotely. ASSESSMENT MEASURES Our measures of feasibility for this study are as follows: • the number of patients referred • the number of referred patients found to be eligible • the number of consenting participants who complete an intervention(s) and offer full data sets Clinical measures of outcome will be as follows: • Hamilton Program for Voices Questionnaire (HPSVQ) (Van Lieshout & Goldberg, 2007) • Voice Impact Scale (VIS) (Strauss et al., 2021) • Choice of Outcome In Cbt for psychosES (CHOICE) (Greenwood et al., 2009) Clinical measures of mechanisms will be as follows: • The Brief Core Schema Scale (BCSS; Fowler et al., 2006) • Beliefs about voices questionnaire - revised (BAVQ-R) (Chadwick et al., 2000) • Approve-Voices (Hayward et al., 2020) • Approve-Social • Five-Facet Mindfulness Questionnaire – 15 (FFMQ-15) (Gu et al., 2016) INTERVENTION PROCESS Following the baseline assessment, all participants will receive the GiVE intervention delivered by a briefly trained therapist. Following the completion of the GiVE intervention, an expert consultation will be offered by the CI and will facilitate the selection of the next step within the intervention pathway (either leave the pathway or Relating Therapy or Person Based Cognitive Therapy). If selected, the second intervention will be delivered by a highly trained therapists. The intervention pathway will be offered over a maximum of 20 sessions, thereby adhering to recommendations within NiCE (2014) guidance for CBT to be offered to psychosis patients over a minimum of 16 sessions. GiVE intervention GiVE is an 8-session intervention that follows a workbook (Hazell et al., 2018) which is based upon the Overcoming Distressing Voices self-help book (Hayward et al., 2018). Participants will be given a copy of both the workbook and the self-help book at the commencement of intervention and asked to engage in some level of self-help (homework); this will take the form of reading chapters from the self-help book between sessions and engaging with the suggested activities within the workbook. Participants in the GiVE intervention will also have the opportunity to access the ‘CHOICES’ mobile phone application. After an introductory session on coping, the intervention will cover three core modules: (1) beliefs about the self, (2) beliefs about voices and (3) relationships. Modules (1) and (2) draw upon psychoeducation and cognitive behavioural strategies to help participants to re-evaluate their negative or unhelpful beliefs related to the self and voices. Module (3) additionally involves work on how to relate to others and voices more assertively. The GiVE intervention has generated between-groups effects sizes in the medium range (relative to treatment-asusual) for voice-related distress when delivered by by briefly trained therapists (Hayward et al., 2021). Relating Therapy Relating Therapy (RT) is a 16-session intervention which supports patients to respond assertively within difficult relationships with voices and other people. Therapy is conducted over three phases of: - Phase 1: socialization to RT and its implications for the interrelating between the hearer and the voice/other people. Consideration of the typical ways of responding to negative relating. Introduction of the possibility of relating differently to voices/other people. - Phase 2: exploration of themes within the relational history of the hearer and their experience of relationships with voices, and interpersonal relating within the family and social environment (identifying any prominent themes, such as abuse, disempowerment, or rivalry). Development of connections across all forms of relating. - Phase 3: exploration and development of assertive approaches to relating to voices/other people. Selection of a relationship to be the focus of treatment. Exploration of a current conversation within chosen relationship, responses within this conversation, identifying responses as passive, aggressive, or assertive and the generation of assertive responses. Experiential role-plays are used extensively within this phase to explore and practice relating in an assertive manner. RT has generated between-groups effect sizes in the large range (relative to treatment-as-usual) for voice-related distress when delivered by Clinical Psychologists (Hayward et al., 2017). As the participant would have been introduced to RT within the ‘relationships’ module of the GiVE intervention, RT within this study will be offered over a shorter course of 12 sessions. Person Based Cognitive Therapy Person Based Cognitive Therapy (PBCT) is a 12-session group intervention which draws upon cognitive behavioural strategies and mindfulness principles to facilitate acceptance of distressing voices and the re-evaluation of beliefs about self and voices. All sessions begin with mindfulness practice and discussion. Mindfulness practice in PBCT is brief (10 min) with frequent guidance that includes reference to voice hearing experiences and combines focussed attention on body and breath with open awareness. Sessions 1–3 socratically draw out participants' voice hearing experiences (onset, impact, meaning, distress and coping) and frame them using the ABC cognitive model. Sessions 4–6 explore personal control, socratically weakening voice omnipotence and enhancing autonomy. Sessions 7–12 add focus on identifying and decentring from negative schemata, and building positive schematic beliefs (including using experiential two chairwork) alongside recognition that the self is complex and changing. Participants are encouraged to practice mindfulness daily at home, using a supplied 10 min recording. PBCT has generated between-groups effect sizes in the medium range (relative to treatment-as-usual) for voice related distress when delivered by Clinical Psychologists (Chadwick et al., 2016). A group intervention is not ideal for a pathway of interventions, as participants may be kept waiting for other participants to be ready to commence the group. Consequently, PBCT will be offered individually over 12 sessions within this study. Therapy sessions will be conducted either face-to-face (at a mental health centre) or remotely (by phone or videocall) in order to respect both patient choice and any restrictions imposed due to the COVID-19 pandemic. All participants will be encouraged to engage in and continue with existing treatments throughout the duration of the study. TRAINING AND SUPERVISION OF THERAPISTS All intervention sessions will be delivered by therapists from SVC. The briefly trained therapists have been previously trained in the delivery of the GiVE intervention by the CI. They will receive weekly supervision from the CI during the study. The highly trained therapists (including the CI) have extensive experience of delivering all the study interventions. They will offer each other weekly peer supervision during the study |
| Intervention type | Behavioural |
| Primary outcome measure | Voice-related distress will be measured using the Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) at baseline, monthly during interventions and post-intervention |
| Secondary outcome measures | 1. The impact of voices will be measured by the Voice Impact Scale (VIS) at baseline, monthly during interventions and post-intervention 2. Recovery will be measured by the Choice of Outcome in CBT for Psychoses (CHOICE) at baseline, monthly during interventions and post-intervention 3. Negative Core Schema will be measured by the Brief Core Schema Scale (BCSS) at baseline, monthly during interventions and post-intervention 4. Beliefs about voices will be measured by the Beliefs About Voices Questionnaire-Revised (BAVQ-R) at baseline, monthly during interventions and post-intervention 5. Relating to voices will be measured by the Approve-Voices measure at baseline, monthly during interventions and post-intervention 6. Relating to other people will be measured by the Approve-Social measure at baseline, monthly during interventions and post-intervention 7. Mindfulness will be measured by the Five-Facet Mindfulness Questionnaire (FFMQ-15) at baseline, monthly during interventions and post-intervention |
| Overall study start date | 01/10/2021 |
| Overall study end date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 14; UK Sample Size: 14 |
| Total final enrolment | 14 |
| Participant inclusion criteria | 1. 18 years or older 2. Under the care of secondary care adult services within SPFT 3. Have a clinician-reported diagnosis of psychosis 4. Are experiencing current voice hearing; this will be operationalized by participants having a score of at least 1 on item 1 (How frequently did you hear a voice or voices?) on the Hamilton Program for Schizophrenic Voices Questionnaire (HPSVQ; Van Lieshout & Goldberg, 2007) - indicating that the participant has experienced at least one episode of voice hearing in the past week 5. Distressed by hearing voices; this will be operationalized by participants scoring at least 8 out of 16 on the ‘negative impact’ scale of the HPSVQ 6. Willing and able to provide written/verbal, informed consent. |
| Participant exclusion criteria | 1. Established organic cause for distressing voices (e.g., brain disease or injury) 2. Primary diagnosis of substance misuse 3. Non-English speaking to the degree that the participant is unable to fully understand and answer assessment questions or give informed consent |
| Recruitment start date | 01/02/2022 |
| Recruitment end date | 04/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Arundel Road
Worthing
BN13 3EP
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Hq
Swandean
Arundel Road
Worthing
BN13 3EP
England
United Kingdom
| Phone | +44 3003040088 |
|---|---|
| researchgovernance@sussexpartnership.nhs.uk | |
| Website | http://www.sussexpartnership.nhs.uk/ |
"ROR" |
https://ror.org/05fmrjg27 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- ESRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Submission for publication in a peer reviewed academic journal, dissemination to participants and patient organizations, and presentations at patient events and at local, national and international conferences. |
| IPD sharing plan | An anonymised dataset will be deposited within the University of Sussex Research Repository to facilitate open access for other researchers. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 03/01/2022 | 04/03/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 30/05/2024 | 04/06/2024 | Yes | No |
Additional files
Editorial Notes
04/06/2024: Publication reference added.
09/08/2023: The contact confirmed the record is up to date.
18/04/2023: The following changes have been made:
1. The recruitment end date has been changed from 28/02/2023 to 04/11/2022.
2. The overall trial end date has been changed from 30/09/2023 to 31/08/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 01/06/2023 to 31/01/2024.
4. The final enrolment number has been added.
21/02/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
