Neurofeedback as a Treatment for Impulsivity in a Forensic Psychiatric Population With Substance Use Disorder: Study Protocol of a Randomized Controlled Trial Combined With an N-of-1 Clinical Trial

BACKGROUND: Impulsivity and substance use disorder (SUD) are strongly interconnected, with persons scoring high on impulsivity being more vulnerable to develop substance abuse, facing more challenges for successful treatment, and being more prone to engage in criminal behavior. Studies have shown that impulsivity and craving for substances are strongly correlated. Neurofeedback is an effective treatment to reduce impulsive behavior. This study intends to determine to what extent a neurofeedback-intervention that is aimed at reducing impulsivity can also reduce levels of craving in forensic patients with SUD and comorbid Axis I and/or II diagnoses. OBJECTIVE: The main objective of this study is to investigate to what extent a reduction in impulsivity by a sensorimotor rhythm (SMR)-neurofeedback intervention will lead to a reduction in craving in a population of forensic psychiatric patients with a diagnosis of SUD. METHODS: Participants will be male SUD patients with various comorbidities residing in an inpatient forensic treatment facility approached through treatment supervisors for participation. Participants have tested positive for drug use in the past 24 months. The study consists of 2 parts: a randomized controlled trial (RCT) and a n-of-1 clinical series. In the RCT, 50 patients will be randomly assigned to an intervention (n=25) or a control (n=25) condition. Patients in the intervention group will receive 20 SMR neurofeedback sessions aimed at reducing impulsivity; participants in the control group receive treatment-as-usual (TAU). Additionally, 4 in depth n-of-1 clinical trials will be conducted where effects of an SMR neurofeedback intervention will be compared to effects of sham neurofeedback. RESULTS: Results of this study are expected by the end of 2017. CONCLUSIONS: This protocol describes the design of a study testing the effects of an impulsivity-based neurofeedback protocol among forensic patients with SUD and various comorbidities. We expect a significant reduction in impulsive behavior, level of craving, and actual drug-use for participants receiving the SMR neurofeedback protocol. The n-of-1 approach might help to explain effects possibly found in the RCT study since it allows for a more direct focus on treatment effects by following participants more closely and thereby being able to directly attribute behavioral and neurophysiological change to the SMR neurofeedback protocol employed. CLINICALTRIAL: Dutch National Trial Register NTR5386; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5386 (Archived by WebCite at http://www.webcitation.org/6nXLQuoLl)