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Talking With Voices II

A novel dialogical therapy (Talking With Voices) in comparison to treatment as usual in adults with distressing and persistent auditory hallucinations: a randomised controlled trial to investigate the efficacy of a treatment strategy targeted at trauma-related mechanisms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15897915
Enrollment
296
Registered
2023-07-13
Start date
2023-09-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis - hallucinations Mental and Behavioural Disorders

Interventions

The study will employ the treatment manual devised and refined during the Talking With Voices feasibility and acceptability trial (https://www.isrctn.com/ISRCTN45308981), which utilises individualised

Sponsors

Greater Manchester Mental Health NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 110 Years

Inclusion criteria

Inclusion criteria: The study population are adult users of mental health services with severe mental health problems (SMHP) who hear persistent, distressing voices. 1. Aged > = 16 years 2. Heard voices for at least a year 3. Scoring > = 1 on item 8 of the Psychotic Symptom Rating Scales–Auditory Hallucinations Subscale (PSYRATS-AH) 4. Able to provide written informed consent 5. Actively help-seeking in relation to distressing voices 6. In contact with mental health services for > = 6 months 7. Willing and able to communicate with their voices and relay what the voices say to a therapist 8. Hear voices that are sufficiently personified to engage in dialogical work

Exclusion criteria

Exclusion criteria: 1. At the immediate risk of harm to self or others 2. Currently receiving structured, individual psychological therapy 3. Non-English speaking 4. Primary diagnosis of alcohol/substance dependence or autism spectrum disorder 5. Moderate/severe learning disability 6. Organic cause for VH 7. Homeless/of no fixed abode

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 06/02/2025: Personal mental health recovery measured using the 15-item Questionnaire About the Process of Recovery (QPR) at 8 months (post-treatment). QPR data will also be collected at baseline and 8 months, and at 14 months (for approximately the first 207 participants). Previous primary outcome measure: Personal mental health recovery measured using the Questionnaire About the Process of Recovery (QPR) at 8 months (post-treatment). QPR data will also be collected at baseline, 8 months, and 14 months.

Secondary

MeasureTime frame
Current secondary outcome measures as of 06/02/2025: Secondary outcome measures are assessed at baseline and 8 months, and at 14 months (for approximately the first 207 participants) unless otherwise stated: 1. Voice hearing phenomenology and impact measured using the Psychotic Symptoms Rating Scale – Auditory Hallucinations Subscale 2. Attitudes and actions in relation to voices measured using the Voices Acceptance and Action Scale 3. The presence and impact of non-auditory hallucinations measured using the Psychotic Symptoms Rating Scale: Multimodal Hallucinations 4. Trauma-related symptoms measured using the PTSD Checklist for DSM-5 5. Daily frequency of dissociation across the domains of absorption, depersonalisation/derealisation, and dissociative amnesia, using The Revised Dissociative Experiences Scale 6. Connections between adverse life events and voices measured using the Trauma Voice Associations Questionnaire Mechanistic outcome measures assessed at baseline, 8 months, and 14 months: 1. Negative self-beliefs measured using the Brief Core Schema Scale 2. Dissociative symptoms measured using the depersonalisation/derealisation subscale of the Revised Dissociative Experiences Scale 3. Beliefs and emotional and behavioural reactions to voices measured using the Beliefs About Voices Questionnaire - Revised 4. Assertiveness in response to voices measured using the Approve–Voices Questionnaire Assessment of baseline characteristics: The incidence of clinically significant traumas measured using the Trauma and Life Events Checklist at baseline Previous secondary outcome measures: Secondary outcome measures are assessed at baseline, 8 months, and 14 months unless otherwise stated: 1. Voice hearing phenomenology and impact measured using the Psychotic Symptoms Rating Scale – Auditory Hallucinations Subscale 2. Attitudes and actions in relation to voices measured using the Voices Acceptance and Action Scale 3. The presence and impact of non-auditory hallucination

Countries

England, United Kingdom

Contacts

Public ContactEleanor;Verity Longden;Bell (nee Smith)

;

eleanor.longden@gmmh.nhs.uk;talkingwithvoices@gmmh.nhs.uk+44 (0)782 455 3926;+44 (0)7950263390

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 27, 2026