Following a treatment conceptualization and development phase, an initial evaluation of the GRIP program has been promising. Our open trial data indicate that, among participants who attended at least 12 sessions of treatment (i.e., completers), GRIP was associated with improvements in almost all measured domains, especially social functioning, positive and general symptoms, and goal attainment. In contrast, early treatment termination (i.e., before 12 sessions) was associated with deterioration in almost all domains, particularly social functioning, negative and general symptoms, perceived social support, and attitudes toward medication. It should be noted that our study design precludes causal inferences about GRIP. In fact, completers and non-completers displayed several differences in their clinical presentations at the beginning of the study. Post hoc examination of our data revealed that non-completers reported less social support, more depressive and positive symptoms, and less social engagement than study completers at baseline. These baseline group differences may shed light on potential predictors of early treatment termination and/or the deterioration in clinical domains that was observed over the course of the study.
The overall sample demonstrated some deterioration with respect to perceived social support, which was an unexpected finding, given the focus on social support in GRIP. Nevertheless, these data are consistent with the phenomenology of first-episode psychosis, in which individuals often report an erosion of social support accompanying their initial experiences with severe mental illness (Norman et al. 2007
). In addition, the provision of treatment may have been associated with increased insight and awareness of reduced social networks (Mintz et al. 2004
). A decrease in perceived social support was greater among treatment non-completers, however, which is consistent with expectations and the aforementioned baseline group differences. That is, these individuals were more likely to resist therapeutic engagement and were more likely to be experiencing greater levels of general social dysfunction.
In addition to promising quantitative results, qualitative feedback on the GRIP program was generally favorable. Most participants, especially treatment completers, provided positive ratings of GRIP on feedback questionnaires. During interactions with study investigators, participants reported that they particularly appreciated the support provided by their therapists, an opportunity to process the experience of their illness, as well as the educational information provided in GRIP. One participant remarked, “It's the only time I get to converse about what's going on with my diagnosis and life.” Therapists also reported positive impressions of the treatment, with most stating that they would highly recommend GRIP to other clinicians working with first-episode clients.
The primary objective of a small open trial is to evaluate the feasibility and tolerability of a new intervention (Mueser and Drake 2005
; Rounsaville et al. 2001
). Our findings with respect to these variables are somewhat mixed. Therapists were able to successfully implement the GRIP protocol with clients and maintained satisfactory fidelity to the treatment manual, per feedback from weekly supervision meetings with DLP. (It should be noted that a formal fidelity manual was not yet available during the open trial, although one has since been developed and is being formally employed in subsequent evaluations of GRIP.) Further, the average dose of treatment in our study (i.e., 15 sessions) was slightly higher than that provided in other small-scale trials of individual CBT for early psychosis (e.g., 10−11 sessions; Haddock et al. 1999
; Jolley et al. 2003
). Overall treatment retention, however, was somewhat lower than expected, with only 67% of participants enrolled in the study completing treatment (not including the individual who attended one therapy session and subsequently withdrew from all treatment services); thus, 33% of participants terminated prematurely. While our retention rate is comparable to that of other studies of individual CBT for early psychosis (e.g., 60−80%; Jackson et al. 1998
; Lewis et al. 2002
; Power et al. 2003
), a dropout rate of 33% suggests the need for additional strategies to improve treatment retention. Indeed, studies of CBT for chronic psychotic disorders have demonstrated more favorable drop-out rates (e.g., 10−15%; Kuipers et al. 1997
; Pilling et al. 2002
A review of our data suggests two primary factors influencing early treatment discontinuation in our sample: logistical (e.g., difficulties with weekly time commitment, balancing several treatment providers) and clinical (e.g., active psychosis, poor insight and appreciation for relevance of treatment). Both therapist and client feedback were consistent in this regard. For example, in a post-treatment interview, one client remarked, “What kind of got to me a little bit was having [sessions] once a week...I would change it to once every two weeks.” Another client remarked that he “didn't feel like [his treatment] goals were being met.” Consistent with this, anecdotal reports by study therapists suggest that the presentation of more structured, didactic material early in treatment may have adversely impacted some clients' desire to remain in treatment. Indeed, this information is critical data to gather in the treatment development process, and has been invaluable in informing necessary modifications to our protocol. Further, our findings appear to reflect the general difficulties of engaging and retaining young people with early psychosis in treatment (EPPIC 2001
; Jackson et al. 2001a
; Judge et al. 2005
Based on lessons learned from our open trial, several modifications have been made to increase engagement and minimize treatment dropouts. For example, GRIP therapists are now “keyworkers” who also provide case management and serve as primary treatment contacts for all clients. This should streamline the treatment process for clients, who are often faced with the challenge of balancing multiple providers and services. In addition, GRIP is being offered in a more flexible format (e.g., option of weekly or biweekly sessions) and therapists are able to meet with clients in the community (e.g., in clients' homes). This assertive outreach approach is frequently used in case management with first-episode clients, and we have now incorporated this perspective into the delivery of GRIP. Further, given the robust support for family-based interventions in improving treatment adherence and clinical outcomes in psychotic disorders (Dixon et al. 2001
), efforts to include family members in the treatment of GRIP clients have been increased. Clients are strongly encouraged to identify an “indigenous supporter” at the onset of treatment, and therapists help to integrate these individuals in the overall care of the client through regular contacts which may include the provision of psychoeducation and support. Finally, in consultation with study therapists, we have begun to make additional modifications to the treatment manual in order to better address the needs of first-episode clients. For example, a module on the psychological impact of a first episode, along with concomitant issues of grief and loss, has been added to Phase One of the treatment.
Thus, preliminary results suggest that GRIP may be associated with clinical benefits, can assist clients in pursuing their personal goals, and is generally well-received by clients and therapists. However, the small sample size, as well as the uncontrolled study design of the open trial, significantly limit the conclusions that can be drawn at this time, and preclude any causal inferences about the efficacy of GRIP. These study limitations are being addressed in a randomized controlled trial (RCT) of GRIP supported by the National Institute of Mental Health, which is currently in progress at the OASIS Clinic. It is hoped that our efforts at modifying GRIP will be successful at keeping young clients engaged, and that the results of our RCT will add to a growing evidence base supporting the efficacy of psychosocial interventions in facilitating recovery in early psychosis.