The Street Smart Group: A Feasibility Trial of a Group Intervention Targeting Anxiety Processes in Paranoia
Condition: Paranoia; Schizophrenia-spectrum Diagnosis
MeSH terms: Schizophrenia; Paranoid Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate a novel group psychological intervention targeting anxiety
      triggered by urban environments for people with paranoia.
    

Detailed description: 
      People with a schizophrenia spectrum diagnosis often experience distressing worries or
      beliefs about other people intending to cause them harm (also known as paranoia). Paranoid
      beliefs are associated with significant distress and disruption to the person's life. This
      results in high use of services and costs to mental health providers.

      The National Institute of Clinical Excellence recommends that cognitive behavioural therapy
      for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The
      latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp,
      making it a cost effective intervention.

      Although improved outcomes have been obtained by therapies, CBTp has only small to moderate
      effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is
      intensive, expensive and takes up to a year. CBTp is therefore not widely available to
      service users, resulting in inequalities in access to care.

      The investigators are seeking to improve outcomes and accessibility of CBTp for people with
      distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility
      study of a brief therapeutic group intervention, aimed at targeting and improving anxiety
      processes which are causally implicated in paranoia.

      The investigators have preliminary evidence indicating that the pilot intervention delivered
      in an individual format, with interactive multimedia content, reduced distressing beliefs and
      improved coping (Freeman et al, 2014). Participants also reported they found the
      interventions acceptable, enjoyable and useful. Based on these results, the investigators
      have further developed the intervention and the current study proposes to evaluate the
      modified intervention delivered in a group format. A pilot randomised controlled trial (RCT)
      of the novel group intervention will be conducted to inform its further development and to
      estimate key parameters required to plan a larger trial.

      The feasibility and efficacy of the therapy will be investigated in a randomised controlled
      design (n = 35) with a between-groups longitudinal design to compare key outcomes between
      people who do and do not receive the intervention and to estimate key trial parameters.
      Participants will be randomised to either an immediate intervention or a delayed intervention
      condition (in which they are offered the intervention after completing all assessments) using
      a 2:1 ratio. Participants will be randomised after completing baseline measures using an
      independent web-based randomisation service. The researchers will be delivering the
      intervention and therefore will not be blind to group allocation. Participants will be
      recruited from community mental health teams and standalone psychology services in the South
      London and Maudsley NHS Foundation Trust.

      As this is a pilot study, the statistical analysis will be mainly descriptive in nature,
      aiming to provide estimates of key trial parameters and to inform power calculations for a
      future larger scale trial. A description of the sample will be presented using means and
      standard deviations for continuous data, or medians and interquartile range if data are
      skewed. Frequencies and proportions will be used to analyse categorical variables.
      Feasibility of trial procedures will be assessed using proportions of predetermined
      parameters and their estimated 95% confidence intervals (CIs). Population variances for
      future power calculations will be determined using the upper 80th percentile of confidence
      intervals around the estimated population variance, as recommended by Browne (1995).
    

Intervention name(s): Anxiety intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment