Look Before You Leap: Representativeness of Those Completing Self-Reports in Early Psychosis Research

Abstract

A randomized controlled trial (RCT) was conducted to compare the efficacy of early intervention (EI) for psychosis extended for 5 years with 2 years of EI followed by 3 years of regular care (details in prior publications). As secondary hypotheses, we postulated that the extended EI group (n 1⁄4 110) would have higher levels of alliance with their treatment providers than the control group (n 1⁄4 110) and that differences in medication adherence and retention in treatment between the two groups would be predicted by working alliance. Alliance was to be measured every 6 months after randomization (i.e., Months 30, 36, 42, 48, 54, and 60) with the Working Alliance Inventory (WAI), a self-report instrument. The average working alliance in the extended EI and regular care groups was 63.53 (SD 1⁄4 12.24, range: 24 to 84, N 1⁄4 85) and 59.35 (SD 1⁄4 12.30, range: 30 to 82, N 1⁄4 46), respectively, t(129) 1⁄4 1.862, P 1⁄4 0.065. The minimum score on the WAI is 12 and the maximum 84, indicating that in both arms, individuals reported moderate to high levels of alliance. Our results should not be interpreted as indicative of a true lack of difference in therapeutic alliance between persons receiving extended EI and regular care, given that individuals in the EI group were significantly likelier to have filled out the WAI at least once during follow-up than those receiving regular care (83% vs.44%, respectively; w 1⁄4 36.129, P < 0.001). We therefore chose not to conduct any additional analyses of the impact of alliance on group differences in medication adherence and retention. Willingness to fill out self-reports may in itself serve as an indicator of alliance/engagement with mental health systems/teams. Earlier, we reported that individuals receiving extended EI were likelier to remain engaged in their followup and have more contacts with their doctors and other treatment providers. That they were also likelier to complete the WAI may be an additional indicator of better “engagement” in the EI group. Assessments were conducted in both arms by the same research assistant. Nonetheless, some factors may have facilitated completion of measures in the EI group. Selfreports and structured interviews to assess symptoms were completed during in-person appointments with the research assistant who was in the same institution as the EI program, albeit in a separate pavilion. When individuals could not come in person, the research assistant completed the structured symptom interviews on the telephone. Self-reports, however, could not be done telephonically. This may have contributed to a higher rate of completion of symptom assessments (our primary outcome). If individuals consented, self-report measures were mailed to them, but very few mailed measures were returned. In the context of an RCT, it was important for the research assistant to be blind to treatment condition. This impeded us from adopting methods that prior research including in psychosis suggests may have facilitated completion of self-reports, for example, asking people to complete selfreports during their clinical appointments, so that completed measures could inform treatment decision-making in real time. Because a sizable number of individuals did not ever fill out the WAI, we examined the differences between individuals who completed the WAI during at least one of the six time points (n1⁄4 139) versus those who never completed it at any time point (n 1⁄4 81), irrespective of treatment condition. Although 139 individuals filled out the measure, 8 left out individual items, resulting in a total of 131 individuals for whom average WAI could be calculated. There was no significant difference between those who completed the WAI