Clinical trial NCT04260763: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia; Psychosis
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Semi-Structured Qualitative interview: Service user acceptability
timeFrame: End of therapy (4 weeks)
Secondary outcomes:
measure: Bell Lysaker Emotion Recognition Task
timeFrame: End of therapy (4 weeks)
measure: Ambiguous Intentions Hostility Task
timeFrame: End of therapy (4 weeks)
measure: Hinting Task
timeFrame: End of therapy (4 weeks)
measure: Empathy Quotient
timeFrame: End of therapy (4 weeks)
measure: Work and Social Adjustment Scale
timeFrame: End of therapy (4 weeks)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Matteo Cella, PhD
role: PRINCIPAL_INVESTIGATOR
References: