The Street Smart Group: A Feasibility Trial of a Group Intervention Targeting Anxiety Processes in Paranoia

NCT02408198 | Completed Phase 2 Results

• 1 other identifier: R&D 2013/066
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Paranoia; Schizophrenia-spectrum Diagnosis

Outcome Measures

Primary Outcomes (1)

• Green Paranoid Thoughts Scale (GPTS)

  The GPTS consists of two 16-item scales. Ideas of reference (part A) and ideas of persecution (part B) are rated over the past month on a scale ranging from one (not at all) to five (totally). A total score is produced by summing all items for part A and B (minimum score = 32; maximum score = 160). A higher score indicates more paranoid thoughts.

  Assessed at baseline, at 6 weeks and 10 weeks

Study Arms (2)

Immediate therapy

EXPERIMENTAL

Therapy will be delivered for a period of 6 weeks immediately after randomisation

Behavioral: Anxiety intervention

Delayed therapy

NO INTERVENTION

Therapy will be delayed until 10 weeks following randomisation, and then delivered over a 6 week period

Interventions

Anxiety intervention BEHAVIORAL

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.

Immediate therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self reported worries about being harmed or at risk from others
• Non-affective psychosis(ICD10,F20-F29)
• Age 18-65
• Symptoms stable no major relapse or crisis in last 3 months prior to consent
• Sufficient command of English to provide informed consent, complete the measures and participate in the brief interventions
• Score above the cutoff for clinically significant levels of paranoia on the Green Paranoid Thoughts Scale (Green et al, 2008)
• Paranoia is triggered by being outside

You may not qualify if:

• Lack of capacity to provide informed consent
• Primary diagnosis of drug or alcohol use with secondary psychosis
• Primary diagnosis of mood disorder or bipolar affective disorder
• Primary diagnosis of learning difficulty
• Unstable residential arrangements (making a move away during the course of participation in the research likely)

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London

London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Paranoid Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Amy Hardy
• Organization: King's College London

amy.hardy@kcl.ac.uk

0207 848 0033

Study Officials

• Philippa Garety, CPsychol, MPhil, PhD, FBPsS

  King's College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Clinical Psychologist

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 18, 2020
• Results First Posted: February 18, 2020

Record last verified: 2020-02

Locations

GB (1)