ECLIPSE Study 9: Building resilience and recovery through enhancing cognition and quality

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Current Interventions (as of 15/01/2018): Consenting patients will be randomised in blocks of 15 stratified by research site at week 0, week 14/15 and week 28/30, with randomisation in proportions 4:4:3:4 (group CRT/independent CRT/ intensive CRT/ treatment‐as‐usual). Alternative randomisation allocations will be used in the scenario where 15 participants cannot be recruited within the 12‐week recruitment period, down to a minimum of 11 participants. This flexibility will allow more efficient use of time and resources (e.g. in case of unexpected participant’s withdrawal). All CRT interventions (intensive/group/independent) will be carried out using computerised cognitive remediation (CIRCUITS Programme). There will be three regimes with different associated hours of therapist contact but all with 42 treatment hours. Intensive CRT group: All participants are offered 10.5 weeks of twice weekly individual therapy. The sessions last for around 60‐180 minutes and are in 3 parts: 1. 20‐60 minutes of CRT with a therapist 2. 20‐60 minutes of in vivo transfer work (i.e. putting CRT strategies into real life) with a therapist 3. 20‐60 minutes of independent CRT, set up by the therapist on site, and done off‐site in the patient’s own time Each patient receives up to 42 hours of CRT (21 with therapist, 21 independently) and 21 hours of in vivo transfer work (with a therapist). Group CRT group: All participants attend 14 weeks of three times weekly group therapy (up to 42 hours of CRT in total). The groups have closed membership and include 4 participants per group with one therapist leading the sessions. Each session lasts for 1 hour, with attendance for at least 20 minutes considered have completed a session. Group sessions begin and end with group activities, relating to goal‐setting and metacognition. During the rest of the session, patients work independently on CIRCuiTS tasks (at the same time) with the therapist offering help and support to individuals on an as‐needed CONDITION: Specialty: Mental Health, Primary sub‐specialty: Psychosis ‐ schizophrenia ; Mental and Behavioural Disorders ; Non‐affective psychosis PRIMARY OUTCOME: Achievement of goals is measured using the Goal Attainment Scale at baseline, post‐CRT and at 6 months follow up SECONDARY OUTCOME: 1. Total number of hours of structured activity per week is measured using The Time Use Survey at baseline, post‐CRT and at 6 months follow up; 2. Costs of health and social care use measured using The Client Service Receipt Inventory at baseline, post‐CRT and at 6 months follow up; 3. Quality‐adjusted life years (QALYs) measured using the EQ‐5D at baseline, post‐CRT and at 6 months follow up; 4. Self‐esteem measured using the Rosenberg Self Esteem Scale at baseline, post‐CRT and at 6 months follow up INCLUSION CRITERIA: Current participant inclusion criteria (as of 15/01/2018) 1. Attending an Early Intervention Service for at least three months 2. Aged between 16 and 45 3. Research diagnosis of non‐­affective psychosis, i.e. schizophrenia, schizo­affective or schizophreniform disorder 4. Ability to give informed consent Previous participant inclusion criteria 1. Attending an Early Intervention Service for at least six months 2. Aged between 16 and 35 3. Research diagnosis of non‐­affective psychosis, i.e. schizophrenia, schizo­affective or schizophreniform disorder 4. Ability to give informed consent
Epistemonikos ID: a252f6c4828f43a2fc451c25da813c0570467dec
First added on: Aug 24, 2024