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Increasing access to CBT for psychosis patients

Not Applicable
Completed
Conditions
Schizophrenia or other psychosis
Mental and Behavioural Disorders
Registration Number
ISRCTN16166070
Lead Sponsor
Sussex Partnership NHS Foundation Trust
Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32238176 protocol (added 03/04/2020) 2021 Results article in https://doi.org/10.1192/bjo.2021.983 (added 14/09/2021)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
79
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

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<br> 1. Distress associated with hearing voices measured using a subscale of the Psychotic Symptoms Rating Scale – Auditory Hallucinations (PSYRATS-AH) at T0, T1, T2<br> 2. The negative impact of voices measured using a subscale of the Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) at -t1, T1, T2<br><br> Timepoint(s): Screening/Eligibility (-t1), Baseline: T0, 16 week follow up: T1, 28 week follow up: T2<br>
Secondary Outcome Measures
NameTimeMethod
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