The effect of mindfulness based intervention in cognitive functions and psychological well-being applied as an early intervention in schizophrenia and high risk mental state

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Participants will be randomly allocated (a simple randomized sampling will be used) to the trial or control group by independent researchers using a stratified block randomization procedure with a computer‐generated allocation sequence. Health experts who will implement the MBIs will be blind to this procedure and they will not carry out the assessment. Control group: Participants will receive standard care for this illness (TAU), in other words, pharmacology and psychosocial intervention under clinical guidelines (e.g. social skills workshop). Intervention group: Participants will be provided with the mindfulness‐based intervention (MBI), plus treatment as usual, divided into 24 patients diagnosed with a first episode of schizophrenia and 24 patients in a high‐risk mental state (groups do not include both profiles). This means that both groups will be submitted to 8 sessions of mindfulness workshops adapted for patients with psychosis. The proposed duration for each session is one hour and a half. The frequency is once a week. The intervention will take place at each participating clinical centre and it will be led by a mindfulness instructor specifically trained for this target audience. Follow up for all participants involves assessment, application of neuropsychological tests and self‐reporting questionnaires one week and three months after completing the workshop. Additionally, four weeks after completing the workshop participants will be submitted to semi structured interviews at each participating clinical centre. CONDITION: Schizophrenia and high risk mental state ; Mental and Behavioural Disorders ; Schizophrenia and high risk mental state PRIMARY OUTCOME: Cognitive function is assessed using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) at baseline, 1 week and 3 months post‐intervention SECONDARY OUTCOME: 1. Psychological well‐being is measured through the Ryff's Psychological Well‐Being Scales (PWB) at baseline, 1 week and 3 months post‐intervention; 2. Self‐esteem is measured through the Rosenberg Self‐esteem Scale at baseline, 1 week and 3 months; 3. Mindfulness is measured through the Five Facet Mindfulness Questionnaire (FFMQ) at baseline, 1 week and 3 months post‐intervention; 4. Affect is measured through the Positive and Negative Affect Schedule (PANAS) at baseline, 1 week and 3 months post‐intervention; 5. Worry is measured through the Penn State Worry Questionnaire (PSWQ‐11) at baseline, 1 week and 3 months post‐intervention; 6. General symptomatology is measured through the Depression, Anxiety and Stress Scale (DASS‐21) at baseline, 1 week and 3 months post‐intervention; 7. Subjective experience is measured through a semi structured interview at four weeks after completing the intervention INCLUSION CRITERIA: 1. Patients diagnosed with a first episode of schizophrenia or in high‐risk of psychosis, as applicable 2. Aged between 15 and 35 years 3. Clinical stability defined by medical and psychometric criteria (e.g. PAANS)
Epistemonikos ID: b02a7b6300bff7f5aeca009d0fd686428dcfc02a
First added on: Aug 24, 2024