NCT04260763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
Last Updated

February 7, 2020

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

August 17, 2018

Last Update Submit

February 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Semi-Structured Qualitative interview: Service user acceptability

    Service user satisfaction as assessed by qualitative interview.

    End of therapy (4 weeks)

Secondary Outcomes (5)

  • Bell Lysaker Emotion Recognition Task

    End of therapy (4 weeks)

  • Ambiguous Intentions Hostility Task

    End of therapy (4 weeks)

  • Hinting Task

    End of therapy (4 weeks)

  • Empathy Quotient

    End of therapy (4 weeks)

  • Work and Social Adjustment Scale

    End of therapy (4 weeks)

Study Arms (1)

Social Cognition Group

EXPERIMENTAL

Social Cognition Group

Behavioral: Social Cognition GroupDevice: Novel Mobile App

Interventions

Each session lasts 90 minutes and includes three 20-minute work packages tapping different social cognition skills; specifically affect recognition and theory of mind/mental state attribution in this study. Examples of the work packages include guessing the emotions of others based on their facial expressions, activities such as indicating how confident participants feel about guessing emotions when looking at more ambiguous pictures, and watching/discussing video clips with content relevant to the group.

Social Cognition Group

The novel homework app was designed to deliver tasks to the participants between group therapy sessions. Three types of task were delivered by the app; 'Stories', 'Emotions', and 'Facts and Guesses'. The 'Stories' task was designed to encourage participants to think about how thoughts, emotions and actions interact. Participants were presented with a short vignette and asked to identify the emotion or behaviour of a character. 'Emotions' aimed to target affect perception by presenting faces of different emotion presentations and asking clients to select the correct emotion from a list of three, whilst 'Facts and Guesses' aimed to address difficulties with jumping to conclusions in social situations by showing clients a photograph of a social situation and asking them to determine whether a given statement about the photo was a "fact" or a "guess". Confidence in answers was also assessed in order to encourage flexible thinking.

Social Cognition Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[for intervention part\].

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Matteo Cella, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2018

First Posted

February 7, 2020

Study Start

August 30, 2018

Primary Completion

April 8, 2019

Study Completion

April 8, 2019

Last Updated

February 7, 2020

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations