Weight gain in patients taking antipsychotic medication for schizophrenia or schizoaffective disorder Signs and Symptoms
Conditions
Interventions
Participants will be allocated to either one of the two intervention conditions or the control condition in a randomised order. Randomisation will be performed by by a researcher from the department w
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years 2. On a stable dose of antipsychotic medication for at least 6 weeks prior to the study enrolment 3. DSM-V diagnosis of schizophrenia or schizoaffective disorder
Exclusion criteria
Exclusion criteria: 1. Significant/unstable medical or psychiatric disorder other than schizophrenia or schizoaffective disorder (e.g. substance dependence) 2. For those taking antidepressant medication - not being on a stable dose for 6 weeks prior to study enrolment 3. Allergies to any of the foods presented in the study 4. Cannot understand verbal English or written information in English 5. History of epileptic seizures, stroke or brain injury 6. Any implanted metal devices in the head 7. Frequent or severe headaches or dizziness 8. Pregnant 9. A tDCS safety questionnaire will also be administered and if considered not safe to deliver tDCS, individuals will subsequently be excluded on this basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim is to assess the feasibility of using ABM training combined with tDCS in people with schizophrenia and to acquire data to inform the development of a large-scale randomised sham-controlled trial (RCT) of this intervention for weight management in this patient group. The specific outcome measures include: 1. Recruitment assessed using recruitment records from the beginning to the end of the recruitment period 2. Attendance assessed using attendance records from the beginning to the recruitment till the end of the trial 3. Acceptability to service users assessed using VAS scores after each treatment session | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary aim is to investigate the effects of five sessions of ABM training combined with tDCS on food craving, impulsivity, cognition, positive and negative symptoms in service users with schizophrenia. The specific outcome measures include: 1. Food craving assessed using Food Craving Questionnaire - State (FCQ-S) along with Visual Analogue Scales (VAS) at baseline and post-treatment sessions, and Food Cravings Questionnaire - Trait - Reduced (FCQ-T-r) at baseline, post-treatment and follow-up sessions 2. Disordered eating behaviour assessed using Eating Disorder Examination (EDE-Q) at baseline and post-treatment sessions 3. Impulsiveness assessed using Barrett Impulsiveness Scale (BIS-11) at baseline and post-treatment sessions 4. Depression, anxiety and stress assessed using Depression, Anxiety and Stress Scale (DASS-21) at baseline, post-treatment and follow-up sessions 5. Positive and negative symptoms of schizophrenia assessed using Positive and Negative Syndrome Scale (PANSS-6) at baseline and post-treatment sessions 6. Cognition assessed using Montreal Cognitive Assessment (MoCA) at baseline and post-treatment sessions 7. Approach bias towards high-calorie food items assessed using Food Approach-Avoidance Task (F-AAT) and Stimulus Response Compatibility Task (SRC) at baseline and post-treatment sessions | — |
Countries
England, United Kingdom
Contacts
Public ContactDina Monssen
Outcome results
None listed