A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder.

Deep brain stimulation (DBS) has been proposed for severe, chronic, treatment-refractory obsessive-compulsive disorder (OCD) patients. Although serious adverse events can occur, only a few studies report on the safety profile of DBS for psychiatric disorders. In a prospective, open-label, interventional multi-center study, we examined the safety and efficacy of electrical stimulation in 30 patients with DBS electrodes bilaterally implanted in the anterior limb of the internal capsule. Safety, efficacy, and functionality assessments were performed at 3, 6, and 12 months post implant. An independent Clinical Events Committee classified and coded all adverse events (AEs) according to EN ISO14155:2011. All patients experienced AEs (195 in total), with the majority of these being mild (52% of all AEs) or moderate (37%). Median time to resolution was 22 days for all AEs and the etiology with the highest AE incidence was 'programming/stimulation' (in 26 patients), followed by 'New illness, injury, condition' (13 patients) and 'pre-existing condition, worsening or exacerbation' (11 patients). Sixteen patients reported a total of 36 serious AEs (eight of them in one single patient), mainly transient anxiety and affective symptoms worsening (20 SAEs). Regarding efficacy measures, Y-BOCS reduction was 42% at 12 months and the responder rate was 60%. Improvements in GAF, CGI, and EuroQol-5D index scores were also observed. In sum, although some severe AEs occurred, most AEs were mild or moderate, transient and related to programming/stimulation and tended to resolve by adjustment of stimulation. In a severely treatment-resistant population, this open-label study supports that the potential benefits outweigh the potential risks of DBS.

Exploring the Relationship Between the Acceptability of an Internet-Based Intervention for Depression in Primary Care and Clinical Outcomes: Secondary Analysis of a Randomized Controlled Trial.

Background: Depression is one of the most prevalent psychological disorders worldwide. Although psychotherapy for depression is effective, there are barriers to its implementation in primary care in Spain. The use of the Internet has been shown to be a feasible solution. However, the acceptability of Internet-based interventions has not been studied sufficiently. Objective: To assess the acceptability of an Internet-based intervention (IBI) for depression in primary care, and explore the relationship between expectations and satisfaction and the improvement in the clinical variables in primary care patients receiving this intervention. Furthermore, it offers data about the effects of some sociodemographic characteristics on these acceptability variables and analyzes whether the expectations are related to finalizing the intervention. Methods: Data were based on depressive patients who were participants in a randomized controlled trial. In the present study, we present the data from all the participants in the Internet intervention groups (N = 198). All the participants filled out the expectation and satisfaction scales (six-item scales regarding treatment logic, satisfaction, recommending, usefulness for other disorders, usefulness for the patient, and unpleasantness), the Beck Depression Inventory-II, and the secondary outcome measures: depression and anxiety impairment, and positive and negative affect. Results: Results showed that participants' expectations and satisfaction with the program were both high and differences in expectations and satisfaction depended on some sociodemographic variables (age: older people have higher expectations; sex: women have greater satisfaction). A positive relationship between these variables and intervention efficacy was found: expectations related to "usefulness for the patient" were a statistically related predictor to the results on the BDI-II (Beta = 0.364), and the perception of how logical the treatment is (Beta = 0.528) was associated with change in the clinical variable. Furthermore, the higher the expectations, the higher the improvements exhibited by the patients in all measures evaluated during the ten intervention modules. High expectations were also directly related to finalizing the intervention. Conclusions: This is the first study in Spain to address this issue in the field of IBIs for depression in primary care. The IBI showed high acceptance related to the intervention's efficacy and completion. Research on IBI acceptability could help to implement the treatment offered. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01611818.