Active Assistance for Psychological Therapy 2.0 (Actissist 2.0)
- Conditions
- PsychosisMental and Behavioural Disorders
- Registration Number
- ISRCTN76986679
- Lead Sponsor
- The University of Manchester
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33362612/ app refinement results (added 29/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 172
Current inclusion criteria as of 20/03/2018:
1. Meet ICD-10 criteria for a schizophrenia-spectrum diagnosis (ICD codes F20, F22, F23, F25, F28, F29) as confirmed by the treating clinician or Early Intervention for Psychosis Service entry criteria, operationally defined using the Positive and Negative Syndrome Scale (PANSS) and/or the psychosis transition criteria of the Comprehensive Assessment of At-Risk Mental States
2. In contact with mental health services
3. Within 5 years from onset of first psychotic episode, deemed by the treating clinician
4. Meet a criterion level of positive symptoms severity, indicated by a score of >3 (symptom present) on any PANSS positive item and a score of >3 (symptom present) on any PANSS negative or PANSS general items
5. English speaking
6. Aged 16 years or older
7. Capacity and willingness to provide informed consent
8. Not currently participating in another trial
Previous inclusion criteria:
1. Early psychosis (within 5 years of initial episode), deemed by the treating clinician
2. In current contact with either an early intervention service or a secondary mental health service
3. PANSS total score 65 or more
4. English speaking
5. Aged 16 years or older
6. Capacity to provide informed consent
7. Not currently participating in another trial
Current inclusion criteria as of 20/03/2018:
1. Anyone with psychosis not in contact with a NHS mental health service
2. Anyone less than 16 years old at the point of recruitment
3. Anyone not capable of giving informed consent
4. Non-English proficient
5. Score <3 on all PANSS positive, negative and general items
Previous inclusion criteria:
1. Anyone with psychosis not in contact with a NHS mental health service
2. Anyone less than 16 years old at the point of recruitment
3. Anyone not capable of giving informed consent
4. Non-English proficient
5. Score <65 on PANSS total
6. Current participation in another trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Psychotic symptoms are measured using the Positive and Negative Syndrome Scale (PANSS) at baseline, 12 weeks post randomisation and 24 weeks post randomisation<br><br> Updated 23/04/2018: The primary outcome will be determined at the 12-week (post-randomisation) follow-up timepoint<br>
- Secondary Outcome Measures
Name Time Method