Discussion
psychiatric, impaired metacognition, SPD
PATHOLOGY, SECONDARY, REMISSION
Our pilot, parallel, double-blinded RCT suggested how the proposed experimental intervention (i.e. ESTS) may be as effective as a combination of CBT and psychopharmacological treatment. At the initial assessment there were no differences between the two conditions across any of the variables investigated, and at 1-month follow-up we found no attrition. Both the interventions were possibly safe and feasible, showing a significant reduction of psychopathology and a high rate of completion and remission from SPD diagnosis.The changes across time in the primary outcome (PID-5-BF) are seemingly indicative of non-inferiority of our specifically developed intervention—namely, ESTS—in respect to control group. Although the measure used (i.e. PID-5-BF) is a screening and not a diagnostic tool, the initial and final mean scores are consistent with scores above and below the mean of the normative sample, respectively. Therefore the pre-post changes may be indicative of a clinically significant reduction of personality pathology in both groups (EG and CG). Moreover, a more fine-grained analysis showed how, at certain phases (tSimilarly, two other measures included in the study as secondary outcomes (general symptomatology and metacognition) suggested a possible superiority of the experimental treatment, even if this is in contrast with the non-significance of the differences in remission from diagnosis (see Fig. Rates of remission from diagnosis and drop-outs. These results may be consistent either with a variance caused by the low sample size and other biases or with a greater effectiveness of the experimental treatment. It is possible that a destigmatizing approach to conceptualization, based on an evolutionary model focused on the metacognitive functioning together with the use of experiential techniques aimed at increasing compassion and reactivating the capacity to soothe one’s own suffering may explain this result. Indeed, these two components are distinctive of the early phases of ESTS and potentially different with respect to a good psychiatric management (i.e. CBT and mandatory medication management). CBT’s focus on categorical diagnosis and the use of medication such as antipsychotics may have been perceived as more stigmatizing and so fueling the threat system of the clients. By assuming a possible vicious cycle between reduced ability to experience compassion and self-soothe, and impaired metacognition in those diagnosed with SPD [The present study has several limitations, two of which must be carefully considered, including: A small sample size and possible therapist effect bias. First, the number of randomized patients did not allow for generalizing the results across the whole reference population of persons diagnosed with SPD. The registered sample size calculation was consistent with the pilot and exploratory nature of the RCT. We collected promising evidence (e.g. a larger increase of metacognition and larger reduction of general symptomatology in the EG) to confirm subsequently. Second, we opted for recruiting only two therapists, and this limited number may have resulted in a reduced quality of the study, such that reported outcomes may be more indicative of therapists’ competencies than interventions effectiveness. On the other hand, if we would have opted for recruiting more therapists, the variance in their competences and skills would have probably represented another significant bias and limitation of the study: EG is a novel treatment that requires diversified skills and few therapists have experience in treating SPD regardless of the approach used. A cost–benefit assessment prompted us to reduce a source of variance by defining tight inclusion criteria to choose the two therapists closest to an ideal training curriculum that does not exist yet. Future studies should confirm our preliminary results in a larger sample and through a more rigorous RCT. More specifically, it would be pivotal to recruit several therapists to randomize and allocate between two specific curricula in order to be trained in the two treatment conditions.We would consider at least three other limitations. The primary outcome was assessed through a measure (i.e. PID-5-BF) that has several advantages for the patients, including its brevity and simplicity, however at the same time scholars have raised criticisms concerning its reliability [