Manualized Group Cognitive-behavioral Therapy for Social Anxiety in First Episode Psychosis: A Randomized Controlled Trial

Preamble

Social anxiety is highly prevalent in people with schizophrenia and related psychotic disorders, and represents a major obstacle to a positive functional outcome. The investigators have recently developed a psychosocial intervention for social anxiety that is specifically tailored to people with psychosis. An adapted Cognitive-Behavioural Therapy (CBT) intervention for psychosis must target the stigma attached to the illness, the possible presence of poor social skills, delusional and persecutory ideas, potential limited reading abilities, and associated cognitive deficits that are the hallmark of schizophrenia and related psychoses. Our preliminary data from an uncontrolled evaluation of our new intervention in first episode psychosis revealed a significant positive impact of this 13-week group intervention for manifestations of social anxiety. Following these promising results, the investigators now propose to conduct a multi-center randomized controlled trial to test the efficacy of this intervention relative to an active control condition consisting of a cognitive remediation group. Their primary goal is to show the efficacy of this intervention on symptoms of social anxiety as determined by self-report measures and clinician-rated measures. Their secondary goal is to examine the impact of such an intervention on clinical and functional outcomes. The highly impairing nature of social anxiety in psychosis is well established and the proposed trial will ultimately show that treating this aspect of the condition is possible and will result in improved functioning.

From 2010 to 2012, the investigators have offered their CBT intervention for social anxiety to several groups of patients at the Douglas Institute and now, more recently, at the McGill University Health Centre (MUHC). The investigators have employed an uncontrolled design recommended to evaluate the feasibility and potential benefits of a pilot psychosocial intervention. In their feasibility study, they offered this intervention to five groups of clients who were part of the Prevention and Early Intervention Program for Psychosis (PEPP-Montreal) and to two groups of clients with longer standing illness, from the Psychosis Program at the Douglas Institute and from the MUHC, respectively. All participants were referred by their treating team (e.g. psychiatrist, nurse, case manager, etc.) and were screened by our research team to evaluate the presence of significant social anxiety. They assessed the effects of this intervention using four scales: Social Interaction Anxiety Scale (SIAS), the Social Phobia Inventory (SPIN) and the Brief Social Phobia Scale (BSPS), Structured Clinical Diagnosis (SCID-I) for Diagnostic and Statistical Manual (DSM-IV).

Focusing on their work in FEP at our program PEPP-Montreal, 25 out of 29 participants who were recruited for the feasibility study met diagnostic criteria for social phobia, whereas 4 represented 'borderline' cases that were clearly reporting significant difficulties with social interactions and active avoidance of social situations. From the 29 clients who started the group intervention, 3 did not complete it (completion defined as attending more than 50% of the sessions). The overall attendance rate of completers of the weekly 13-week program was excellent, with an average of 11 sessions attended per participant (ranging from 9-13), confirming that the intervention was well tolerated by the participants. For the 26 patients who completed the intervention, a significant reduction in social anxiety was observed on all three measures (SPIN, SIAS, BSPS) at the end of the 13-week treatment. We observed effect sizes of 1.04 on the SIAS, 0.93 on the SPIN, and 0.95 on the BSPS, after correcting for within-subject dependence among means for the total sample of participants who completed the intervention. These effect sizes are quite large and represent a strong justification to pursue a larger-scale investigation of this novel intervention. Critically, from the 24 participants with a SCID-I based diagnosis of social phobia prior to the treatment, only two still met diagnostic criteria at the end of the study. Moreover, the investigators administered the Internalized Stigma of Mental Illness (ISMI) scale and observed a significant reduction in stigma following this intervention (p<.01), suggesting that our intervention does indeed target stigma in an efficient way.

Having established the potential benefits of our new psychosocial intervention for social anxiety, the investigators devised a control condition to reproduce some of the aspects of our group intervention without the active ingredients of group CBT. An active control condition that could control for spontaneous changes in symptoms of social anxiety, the effect of being in a trial, and therapeutic commitment was chosen. In the selection of an active control condition, it is essential that this intervention does not target social anxiety while still controlling for the non-specific effects described above. As discussed by Everitt, a control intervention that does not target the symptoms of interest should potentially lead to a greater effect size between the experimental treatment and the control condition, and as such requires a smaller sample. Several researchers have attested to the appropriateness of cognitive remediation therapy (CRT) as a control condition for CBT intervention: two recent large multi-center trials involving a group CBT intervention to improve patients' insight into their illness or to improve negative symptoms have used CRT as their active control condition. CRT targetting cognitive performance can be offered in a group format and thus represents a very promising control condition for the proposed study.