Investigation of attention training for people with psychosis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: STUDY DESIGN The study will be a single (rater) blind randomised feasibility study with two conditions; Attention Training Technique (ATT) plus treatment as usual (TAU) vs. TAU alone for people with psychosis. The trial will randomly allocate participants who meet criteria to a 12‐week package of either condition. Assessors blind and independent to treatment group will conduct assessments at baseline, post‐treatment (3 months) and follow‐up (6 and 12 months). The main trial will include a nested qualitative study that will identify key themes associated with the acceptability of ATT for people with psychosis and experiences of being involved in the trial as well as staff views. SAMPLE SIZE A sample size of 60 is considered adequate for obtaining reliable sample size estimates to facilitate the main aims of a feasibility study. Based on requiring 60 participants across conditions a target recruitment of 76 (38 per condition) over the recruitment period would allow a dropout rate of 20% although this is likely to be lower. RECRUITMENT Recruiting to target will rely on case‐finding through services. The trial will be run from the Psychosis Research Unit (PRU) at Greater Manchester Mental Health NHS Foundation Trust where the CI is based. Potential participants will be identified via care‐coordinators and relevant mental health staff in community mental health teams (CMHT). CMHT’s will be made aware of the study via regular liaison from researchers. Participants may also identify themselves as suitable for the study via the Greater Manchester FAIR (Free Access to Involvement in Research) system or by contact numbers provided on press releases and posters. RANDOMISATION Following written consent and assessment, eligible participants will be randomised within 2 working days of eligibility being confirmed. Randomisation will be undertaken using Sealed Envelope software (https://www.sealedenvelope.com/). Randomisation (at the individual level) will be independent and c CONDITION: Specialty: Mental Health, Primary sub‐specialty: Psychosis ‐ schizophrenia; UKCRC code/ Disease: Mental health/ Schizophrenia, schizotypal and delusional disorders ; Mental and Behavioural Disorders ; Schizophrenia PRIMARY OUTCOME: 1. Recruitment as measured by number of referrals and number consenting and randomised; Timepoint: Baseline; 2. Retention as measured by percentage follow‐up and questionnaire response rates; Timepoint(s):; 6 weeks, 12 weeks, 6 and 12 months assessment points INCLUSION CRITERIA: 1. In contact with community mental health services 2. Meets ICD‐10 criteria for Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic disorder not due to a substance or other or known physiological condition. 3. Score four+ on PANSS delusions/hallucinations items 5+ on suspiciousness/grandiosity 4. Help seeking 5. Willing and able to provide written informed consent 6. Aged 16 or above SECONDARY OUTCOME: 1. Attendance at intervention sessions, adherence to between session work as measured by number attended and between session tasks completed; Timepoint(s): 12 weeks; 2. Qualitative interview exploring the personal experiences of involvement in the trial (including both arms) using the topic guide; Timepoint(s): 12 weeks +; 3. Mental health symptoms – psychosis as measured by Positive and Negative Syndrome Scale (PANSS); anxiety & depression as measured by the Hospital Anxiety and Depression Scale (HADS); drug and alcohol use as measured by the Alcohol Use Disorders Identifical Tool (AUDIT) and Drug Use Disorders Identification Tool (DUDIT); Timepoint(s): 6 weeks, 12 weeks, 6 and 12 months assessment points; 4. Metacognitive beliefs and processes as measured by Metacognitions Questionnaire (MCQ‐30), Cognitive Attentional Syndrome Scale (CAS) Attentional Control Scale (ACS); Timepoint(s): 6 weeks, 12 weeks, 6 and 12 months assessment points; 5. Recovery as measured by the Questionnaire about Process of Recovery (QPR), functioning as measured by the Global Assessment of Functioning (GAF) and quality of life as measured by the World Health Organisation Quality of Life measure (WHOQOL); Timepoint(s): 6 weeks, 12 weeks, 6 and 12 months assessment points
Epistemonikos ID: 70c81aea34e2af504dc73216f984659ff39bcf6b
First added on: Aug 24, 2024