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Evaluating a Novel Mobile App for Social Cognition in Psychosis

Primary Purpose

Schizophrenia; Psychosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Social Cognition Group
Novel Mobile App
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia; Psychosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Social Cognition Group

Arm Description

Social Cognition Group

Outcomes

Primary Outcome Measures

Semi-Structured Qualitative interview: Service user acceptability
Service user satisfaction as assessed by qualitative interview.

Secondary Outcome Measures

Bell Lysaker Emotion Recognition Task
Measures of affect recognition. . Participants are invited to watch 21 videos lasting ten seconds each, of a male actor displaying seven different emotions: happy, sad, afraid, surprised, angry, disgusted or no emotion, and then identify which emotion they think it being portrayed. This is the emotion perception measure recommended by the Social Cognition Psychometric Evaluation (SCOPE) group for studies evaluating social cognition interventions
Ambiguous Intentions Hostility Task
Measure of attributional bias. Participants are read five, hypothetical negative situations with ambiguous causes, asked to imagine that this is happening to them, and then come up with an explanation for how the situation occurred. Participants are asked whether the character in the story was acting purposefully, how angry they feel, and how much they blame the character, using Likert type responses. This measure takes approximately 6 minutes to administer.
Hinting Task
Measure of Theory of Mind. The participants are read ten short passages portraying an interaction between two people, at the end of which one character drops a hint. The participant is asked what the character really meant, as a way to assess how well they can infer meaning from indirect speech. This is the measure for theory of mind/mental state attribution recommended by SCOPE. This measure takes approximately 6 minutes to administer.
Empathy Quotient
Measure of empathising abilities/emotional intelligence. This can be viewed as a more 'global' measure of social abilities as opposed to domain specific (i.e. emotion perception, theory of mind). This is a 22-item self-report measure, and takes approximately 6 minutes to administer.
Work and Social Adjustment Scale
Measure of Community Functioning. This is a five item self-report measure which asks participants how much their mental health problems effect their ability to work, manage their home, engage in leisure activities and have social relationships, using a nine-point scale (from 0 - not at all, to 8- very much so). Additionally, participants are asked how likely they feel this is to change in the future using the same scale.

Full Information

First Posted
August 17, 2018
Last Updated
February 6, 2020
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT04260763
Brief Title
Evaluating a Novel Mobile App for Social Cognition in Psychosis
Official Title
Evaluating the Feasibility and Acceptability of a Novel Mobile Intervention Targeting Social Cognition in Individuals With Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
April 8, 2019 (Actual)
Study Completion Date
April 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia; Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Cognition Group
Arm Type
Experimental
Arm Description
Social Cognition Group
Intervention Type
Behavioral
Intervention Name(s)
Social Cognition Group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Novel Mobile App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Semi-Structured Qualitative interview: Service user acceptability
Description
Service user satisfaction as assessed by qualitative interview.
Time Frame
End of therapy (4 weeks)
Secondary Outcome Measure Information:
Title
Bell Lysaker Emotion Recognition Task
Description
Measures of affect recognition. . Participants are invited to watch 21 videos lasting ten seconds each, of a male actor displaying seven different emotions: happy, sad, afraid, surprised, angry, disgusted or no emotion, and then identify which emotion they think it being portrayed. This is the emotion perception measure recommended by the Social Cognition Psychometric Evaluation (SCOPE) group for studies evaluating social cognition interventions
Time Frame
End of therapy (4 weeks)
Title
Ambiguous Intentions Hostility Task
Description
Measure of attributional bias. Participants are read five, hypothetical negative situations with ambiguous causes, asked to imagine that this is happening to them, and then come up with an explanation for how the situation occurred. Participants are asked whether the character in the story was acting purposefully, how angry they feel, and how much they blame the character, using Likert type responses. This measure takes approximately 6 minutes to administer.
Time Frame
End of therapy (4 weeks)
Title
Hinting Task
Description
Measure of Theory of Mind. The participants are read ten short passages portraying an interaction between two people, at the end of which one character drops a hint. The participant is asked what the character really meant, as a way to assess how well they can infer meaning from indirect speech. This is the measure for theory of mind/mental state attribution recommended by SCOPE. This measure takes approximately 6 minutes to administer.
Time Frame
End of therapy (4 weeks)
Title
Empathy Quotient
Description
Measure of empathising abilities/emotional intelligence. This can be viewed as a more 'global' measure of social abilities as opposed to domain specific (i.e. emotion perception, theory of mind). This is a 22-item self-report measure, and takes approximately 6 minutes to administer.
Time Frame
End of therapy (4 weeks)
Title
Work and Social Adjustment Scale
Description
Measure of Community Functioning. This is a five item self-report measure which asks participants how much their mental health problems effect their ability to work, manage their home, engage in leisure activities and have social relationships, using a nine-point scale (from 0 - not at all, to 8- very much so). Additionally, participants are asked how likely they feel this is to change in the future using the same scale.
Time Frame
End of therapy (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Cella, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating a Novel Mobile App for Social Cognition in Psychosis

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