Reducing The Duration Of Untreated Psychosis & Its Impact In The U.S.: The STEP-ED Study

The following is a summary of Srihari VH, Tek C, Pollard J, et al. Reducing the duration of untreated psychosis and its impact in the U.S.: the STEP-ED study. BMC Psychiatry. 2014;14(1):335, which was developed independently of the article authors. This summary describes the rationale and methodology of the STEP-ED study. No study results are presented in this paper.

• Even with routine care, outcomes for patients with first-episode psychosis are poor, with less than one-fifth of patients fully recovering and less than one-third achieving minimal age-appropriate employment or education.
• Early intervention is thought to improve outcomes for patients with first-episode psychosis.
  • Early intervention can be conceptualized as interlocking strategies: early detection (ED), which attempts to shorten the duration of untreated psychosis (DUP) by shorting the time between psychotic symptom onset and the provision of effective treatment, and comprehensive intervention in the 2–5 years following diagnosis.
• As part of a comprehensive intervention, teams referred to as first-episode services (FES) integrate empirically supported therapies and adapt their delivery to younger patients and their caregivers.
• Evidence exists to suggest benefits of ED in reducing DUP and increasing the impact of existing FES.
  • The Norwegian TIPS study, which is the largest reported assessment of ED to date, was a comparative study that compared public and targeted education campaigns in conjunction with rapid availability of FES (assessment group) to a comparable FES group that did not have an ED program (comparison group).
  • The TIPS study reported a shortened DUP in the assessment group, which was associated with decreased positive and negative symptoms and suicidality at presentation, and which appeared to result in improved long-term recovery compared to the comparison group.
  • These findings suggest a causal effect of DUP in affecting outcomes in first-episode psychosis.
• Direct implementation of a TIPS approach in the U.S. healthcare setting may be difficult owing to differences in treatment delivery and in the overall healthcare environment between the two countries, suggesting the necessity of empirical evaluation of this approach within the U.S.

• This study will assess the effectiveness of a new ED campaign in the U.S. to determine whether the use of ED in combination with FES can reduce DUP and improve outcomes compared to existing FES approaches.

Regarding study aims

• The primary aim of the study is to assess whether ED can reduce DUP in the U.S. compared to usual detection.
• The secondary aim of the study is to assess whether a reduction in DUP can affect the outcomes achieved by existing FES programs.

Regarding study groups

• Two groups will be included in this quasi-experimental study: the assessment group will consist of a currently existing FES program (Specialized Treatment Early in Psychosis [STEP]) from New Haven, CT, which will incorporate an ED program (thus becoming the STEP-ED program) and the comparison group will be the PREP program from Boston, MA, a FES program without an ED component that instead utilizes usual detection efforts (i.e., use of prodrome clinics and customary referral sources).
• Measurement of DUP will be undertaken within one major community mental health center within the STEP-ED catchment area by regularly reviewing clinical records to determine the prognostic profile and DUP of patients who were not successfully referred to STEP for treatment initiation.

Regarding the STEP-ED program

• The STEP-ED program seeks to decrease sources of delay contributing to DUP.
• Through input from stakeholders, the STEP-ED program will include a public education campaign (PEC) and outreach to and detailing of professionals (e.g., police/jail diversion, religious centers, educational-based clinics and counseling services, healthcare centers, emergency services) and all major treatment centers, and will incorporate performance improvement tactics (referred to as Rapid Access to STEP [RAS]) with the aim of reducing the time between referral and admission to STEP.
• The initial year of the study period will roll out public education and professional outreach and detailing campaigns.
  • The PEC campaign will target individuals with early psychosis who have not made contact for medical care of their condition, as well as their caregivers and close contacts.
    • The campaign, which will be channeled through traditional and social media, will include messaging regarding the identification of the signs/symptoms of psychosis, how to access professional evaluation and effective care through STEP, and the importance of early treatment.
  • The professional outreach and detailing (POD) campaign will initially utilize interpersonal approaches (e.g., face-to-face meetings, workshops) and resource materials, followed by detailing of any referral sources identified through the initial interpersonal approaches.
• In years 2–4 of the study, following completion of the PEC and POD campaigns, RAS tactics will be implemented and will include various performance improvement measures that have the potential to decrease the time between referral and entry into the STEP program (e.g., structured telephone screening; target timelines for milestones; problem-solving support).

Regarding study population

• STEP-ED will be conducted in areas of New Haven, CT and PREP will be conducted in areas of Boston, MA.
• Over the past 5 years, the STEP-ED and PREP programs have reported comparable participant demographic and prognostic profiles.
• Participants in either program will be 16–35 years of age, living within the area of interest, and have had a first-episode of psychosis within the past 3 years.
• Exclusion criteria will include established diagnosis of affective psychosis or psychosis secondary to substance use or medical illness, inability to communicate in English, a legal mandate to begin treatment, inability to reliably determine DUP, and unstable serious medical illness.
• A flexible method was used to determine the required sample size and power, and utilized historical data on the effect of PREP and STEP on DUP.
  • Target sample sizes are 66 participants at PREP and 133 at STEP-ED in the pre-campaign period (Year 1) and 66 and 102, respectively, during the post-campaign period (Year 2–4).

Regarding outcome measures

• Onset of DUP will be defined using the threshold criteria for positive or disorganized symptoms of psychosis in the Symptom Onset Scale (SOS).
• Offset of DUP will be defined as ending on the date of initiation of antipsychotic medication for the treatment of psychosis.
• The impact of ED on DUP will be measured using an adaptation of the Pathways to Care Interview, which gathers information from patients, caregivers, and medical records regarding the source, motivation, sequence, and timing of help-seeking behavior; the response offered by their first contacts for help; and the sequence and duration of later contacts until entry into the FAS.
• The impact of DUP reduction on 1-year outcomes will be derived from the Global Functioning Social and Role Scales, which assess the proportion of patients who are at least in part-time school or work; findings will be compared to Bureau of Labor Statistics definitions of vocational activity.
• Psychiatric diagnoses at baseline and at 1 year will be based on the Structured Clinical Interview for DSM-IV (SCID), and the Structured Interview for Prodromal Syndromes (SIPS) will assess risk for psychosis at baseline.
• Symptoms will be assessed using the Positive and Negative Symptom Scale (PANSS) and the Calgary Depression Scale.
• Behavioral outcomes will be determined using the Modified Overt Aggression Scale (MOAS), Columbia Suicide Severity Scale (C-SSRS), the Alcohol Use and Drug Use Scales, a Habits Inventory, and the SCID.

• This study will assess the effects of the integration of an ED program adapted to the U.S. healthcare pathway into an existing FES program on 1-year outcomes in patients with first-episode psychosis.
• As described by the authors, the unique attributes of this study include its leveraging of existing collaborations in the implementation of ED in a specific geographic area; the use of social marketing to improve access to mental healthcare; and the deliberate use of an interventionist approach (i.e., the targeting of presumed sources of DUP) to assess this intervention in the context of U.S. healthcare pathways.
• This study will assess the implementation of STEP-ED, an early detection (ED) campaign being adapted to US healthcare pathways with the intention of attempting to improve understanding of these pathways and their potential impact on early outcomes in first-episode psychosis.
• By assessing the added value of early detection (ED) to an existing first-episode services (FES) program for patients with psychosis in a controlled manner, effective means of hastening access to established and effective services may be identified.

This summation has been developed independently of the authors. The following disclosures were reported in the original article: “The authors declare that they have no competing interests.”