Schizophrenia or other psychosis Mental and Behavioural Disorders
Conditions
Interventions
Current intervention as of 10/01/2020:
The study will recruit up to 90 people with psychosis who will be randomly allocated into one of three groups:
1. 30 participants
Sponsors
Sussex Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/01/2020: Participants must: 1. Be aged 16 years or older 2. Be in contact with Secondary Care Mental Health Services (under the care of a Consultant Psychiatrist) 3. Be currently experiencing voice hearing; 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) - indicating that the participant has experienced at least one episode of voice hearing in the past week 4. Be distressed by hearing voices; operationalized by participants scoring at least 8 out of 16 on the ‘negative impact’ scale of the HPSVQ 5. Meet DSM-5 Research criteria for Schizophrenia Spectrum or Other Psychotic Disorders (assessed by the Structured Clinical Interview for DSM-5 disorders, SCID-5) 6. Be willing and able to provide written, informed consent Previous inclusion criteria: Participants must: 1. Be 18 years or older 2. Be in contact with Secondary Care Mental Health Services (under the care of a Consultant Psychiatrist) 3. Be currently experiencing voice hearing; 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) - indicating that the participant has experienced at least one episode of voice hearing in the past week 4. Be distressed by hearing voices; operationalized by participants scoring at least 8 out of 16 on the ‘negative impact’ scale of the HPSVQ 5. Meet DSM-5 Research criteria for Schizophrenia Spectrum or Other Psychotic Disorders (assessed by the Structured Clinical Interview for DSM-5 disorders, SCID-5) 6. Be willing and able to provide written, informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 10/01/2020: Participants must not: 1. Have an established organic cause for distressing voices (e.g. brain disease or injury) 2. Have a primary diagnosis of substance misuse 3. Have completed a full course (minimum of 16 hours) of CBT for psychotic symptoms during the past year 4. Be currently participating, or be confirmed to participate in another interventional study in which they are receiving an intervention which utilizes psychological therapy 5. Be non-English speaking to the degree that the participant is unable to fully understand and answer assessment questions or give informed consent 6. Have severe learning disability (mild to moderate will not be excluded) assessed using the TOPF-UK 7. Be at immediate and serious risk to self or other (assessed at the point of referral/eligibility review) 8. Be detained in hospital under a section of the Mental Health Act Previous exclusion criteria: Participants must not: 1. Have an established organic cause for distressing voices (e.g. brain disease or injury) 2. Have a primary diagnosis of substance misuse 3. Have completed a full course (minimum of 16 hours) of CBT for psychotic symptoms during the past year 4. Be currently participating, or be confirmed to participate in another interventional study in which they are receiving an intervention which utilizes psychological therapy 5. Be non-English speaking to the degree that the participant is unable to fully understand and answer assessment questions or give informed consent 6. Have severe learning disability (mild to moderate will not be excluded) assessed using the TOPF-UK 7. Be at immediate and serious risk to self or other (assessed at the point of referral/eligibility review)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Distress associated with hearing voices measured using a subscale of the Psychotic Symptoms Rating Scale – Auditory Hallucinations (PSYRATS-AH) at T0, T1, T2 2. The negative impact of voices measured using a subscale of the Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) at -t1, T1, T2 Timepoint(s): Screening/Eligibility (-t1), Baseline: T0, 16 week follow up: T1, 28 week follow up: T2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Screening measures: 1. Symptoms and experiences assessed using Structured Clinical Interview for DSM-5 Disorders (SCID-5) at -t1 2. Intellectual functioning assessed using Test of Premorbid Functioning – UK (TOPF-UK) at -t1 Clinical measures: 3. Impact of voice-hearing experiences, assessed using the Voice Impact Scale (VIS) at T0, T1, T2 4. Emotional distress assessed using the Hospital Anxiety and Depression Scale (HADS) at T0, T1, T2 5. Outcomes that are important to patients assessed using Choice of Outcome In Cbt for psychosES (CHOICE) at T0, T1, T2 6. Beliefs about the self, assessed using the Brief Core Schema Scale (BCSS) - self scale at T0, T1, T2 7. Relationship between the voice and hearer, assessed using Voice and You (VAY) at T0, T1, T2 8. Social relationships assessed using Persons relating to others questionnaire (PROQ3) at T0, T1, T2 9. Beliefs about voices assessed using Beliefs about voices questionnaire - revised (BAVQ-R) at T0, T1, T2 10. Paranoid delusions assessed using Paranoid Thoughts Scale at T0, T1, T2 11. Therapeutic relationship assessed using Scale to Assess Therapeutic Relationships (in community mental health care) (STAR) at T1 12. Participants’ expectancy about the effectiveness of the therapeutic intervention, assessed using Therapy Credibility and Expectancy Questionnaire at Session 1 of therapy intervention (GiVE and SC arms of the trial) Non-clinical measures: 13. Demographics information assessed using survey at T0 14. Completion of 'homework' tasks assessed using a diary between sessions Social functioning measures: 15. Ability to engage in meaningful activity, assessed using Work and Social Adjustment Scale (WSAS) at T0, T1, T2 | — |
Countries
England, United Kingdom
Outcome results
None listed