Evaluating a Novel Mobile App for Social Cognition in Psychosis

NCT ID: NCT04260763

Last Updated: 2020-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2019-04-08

Brief Summary

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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

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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.

Conditions

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Schizophrenia; Psychosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Social Cognition Group

Social Cognition Group

Group Type EXPERIMENTAL

Social Cognition Group

Intervention Type BEHAVIORAL

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.

Novel Mobile App

Intervention Type DEVICE

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.

Interventions

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Social Cognition Group

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 BEHAVIORAL

Novel Mobile App

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matteo Cella, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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236451

Identifier Type: -

Identifier Source: org_study_id

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