Schizophrenia; PsychosisNCT04260763
Evaluating a Novel Mobile App for Social Cognition in Psychosis
A study testing Social Cognition Group and Novel Mobile App in people with Schizophrenia; Psychosis, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia; Psychosis
- What is being tested?
- Social Cognition Group and Novel Mobile App
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Aug 2018to 8 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Feasibility and Acceptability of a Novel Mobile Intervention Targeting Social Cognition in Individuals With Psychosis
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.
Read the 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.
- Conditions
- Schizophrenia; Psychosis
- Being tested
- Social Cognition Group, Novel Mobile App
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognition GroupBehavioural
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 AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Cognition Group | Experimental | Social Cognition Group Receives: Behavioral: Social Cognition Group; Device: Novel Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-Structured Qualitative interview: Service user acceptability
Service user satisfaction as assessed by qualitative interview.
Measured: End of therapy (4 weeks)
Secondary outcomes (5)
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
Measured: End of therapy (4 weeks)
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.
Measured: End of therapy (4 weeks)
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.
Measured: End of therapy (4 weeks)
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.
Measured: End of therapy (4 weeks)
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.
Measured: End of therapy (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start30 Aug 2018
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Cella, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260763
- Sponsor's protocol ID
- 236451
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Acceptability of a Novel Mobile Intervention Targeting Social Cognition in Individuals With Psychosis
- ClinicalTrials.gov ID
- NCT04260763
- Acronym / sponsor ID
- 236451
- Conditions
- Schizophrenia; Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Cognition Group | Experimental | Behavioral: Social Cognition Group, Device: Novel Mobile AppSocial Cognition Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Cognition GroupEach 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. | Behavioural | Social Cognition Group |
| Novel Mobile AppThe 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. | Device | Social Cognition Group |
Primary outcome
Semi-Structured Qualitative interview: Service user acceptability
Time frame: End of therapy (4 weeks)
Service user satisfaction as assessed by qualitative interview.
5 secondary outcomes
Bell Lysaker Emotion Recognition Task
Time frame: End of therapy (4 weeks)
Ambiguous Intentions Hostility Task
Time frame: End of therapy (4 weeks)
Hinting Task
Time frame: End of therapy (4 weeks)
Empathy Quotient
Time frame: End of therapy (4 weeks)
Work and Social Adjustment Scale
Time frame: End of therapy (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Cella, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition Group and Novel Mobile App in people with Schizophrenia; Psychosis, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-Structured Qualitative interview: Service user acceptability (time frame: End of therapy (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.