Clinical trials

Identifying predictors and understanding mechanisms of change will inform referral to psychotherapy, triage and right-siting by helping clinicians to understand how their patients are likely to benefit from clinical interventions. This study will be the first of its kind conducted in an Asian hospital setting to identify the predictors of response to individual, group and internet-delivered CBT for the treatment of depressed and anxious patients in the Institute of Mental Health (IMH), Singapore. With increasing challenges with hospital workload, there is an increasing emphasis on group and online interventions. Understanding of the factors that may predict outcome from these therapies can improve right-siting by identifying who will get better without therapy or who may not benefit from a given form of therapy and guide personalisation of care. An important biological predictor of outcome is likely to be genetic risk as it has been demonstrated that patients with greater melancholia and a family history may not be sufficiently treated with brief courses of therapy. Identifying psychological factors underlying psychological distress and determining the extent to which these factors are addressed by these interventions will help to improve and individualise existing psychotherapy and motivate new psychotherapeutic interventions.

The present study aims to pilot internet-delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) as a transdiagnostic emotion dysregulation intervention to prevent progression to depression in individuals with adverse childhood experiences (ACEs) and subsyndromal depression. The aims of the study are: (i) to examine the effectiveness of i-STAIR on emotion dysregulation, interpersonal skills, depressive and PTSD symptoms at post-intervention i.e. on completion of the intervention (8 weeks); (ii) to examine if gains were maintained at 3 month post- intervention follow-up.

The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.

Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation (iTBS) to treat negative symptoms in schizophrenia. In this study, we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms. We propose a pragmatic, open label and single arm clinical trial. Forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days. Participants will be followed up immediately, 1 month and 3 months after the end of treatment. Clinical assessment includes, BNSS, The Brief Negative Symptom Scale; SANS, Scale for the assessment of negative symptoms; SAPS, Scale for the assessment of positive symptoms; PANSS, Positive and Negative Symptoms Scale; MoCA, Montreal Cognitive Assessment scale; CDSS, Calgary Depression Scale for Schizophrenia: SDS, Sheehans' disability scale and EQ-5D. The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS, negative symptoms subscale immediately after the treatment. This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need.