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Clinical Trials/NCT04260763
NCT04260763
Completed
Not Applicable

Evaluating the Feasibility and Acceptability of a Novel Mobile Intervention Targeting Social Cognition in Individuals With Psychosis

King's College London1 site in 1 country14 target enrollmentAugust 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia; Psychosis
Sponsor
King's College London
Enrollment
14
Locations
1
Primary Endpoint
Semi-Structured Qualitative interview: Service user acceptability
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

To develop, and then evaluate a mobile phone app to deliver therapy homework activities between group sessions (social cognition intervention) in individuals with psychosis. The investigators are interested in whether offering homework via an app is a) feasible, and b) acceptable.

The investigators will also assess whether there is an initial indication that offering homework via the app improves outcomes following the group therapy.

Detailed Description

This study is a pilot, feasibility trial of a clinical intervention. The investigators will initially pilot the app with three clinical participants, who will be asked to use the app for a period of three days and provide feedback as to whether there are any difficulties with usability, glitches, display, etc. Two therapy groups will then be run consecutively. The therapy delivered will be a modified version of Group Training for Social Cognition in Psychosis (GRASP). Both groups will receive their homework tasks delivered via an app. Participants will undergo an assessment before and after the therapy, and a follow up interview as detailed in the measures section below. Primary objective: To evaluate a mobile app to deliver therapy homework between sessions of a social cognition therapy group for individuals with psychosis. The investigators are interested in whether offering homework via an app is a) feasible, and b) acceptable. Secondary objective: To assess whether there is an initial indication that our intervention improves social cognition skills.

Registry
clinicaltrials.gov
Start Date
August 30, 2018
End Date
April 8, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A diagnosis on the psychosis spectrum (using either DSM 5, DSM-IV, or ICD-10 \[F20-F29\])
  • Age 18-65 years
  • Good command of the English language
  • Premorbid IQ of over 70
  • Owns a smartphone or willing to use a study smartphone for the required period
  • Likely to benefit from social cognition intervention as assessed by clinical team \[for intervention part\].

Exclusion Criteria

  • Lacks capacity to give informed consent to participate in research
  • Poses significant risk to self or others
  • Inability to understand verbal or written English (i.e. inability to understand information sheet or requires an interpreter).
  • High levels of psychotic symptoms which precludes meaningful participation
  • Unsuitable to attend groups (group-therapy part only)

Outcomes

Primary Outcomes

Semi-Structured Qualitative interview: Service user acceptability

Time Frame: End of therapy (4 weeks)

Service user satisfaction as assessed by qualitative interview.

Secondary Outcomes

  • Bell Lysaker Emotion Recognition Task(End of therapy (4 weeks))
  • Empathy Quotient(End of therapy (4 weeks))
  • Work and Social Adjustment Scale(End of therapy (4 weeks))
  • Ambiguous Intentions Hostility Task(End of therapy (4 weeks))
  • Hinting Task(End of therapy (4 weeks))

Study Sites (1)

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