Focus of Study Clinical Trial
NCT number | NCT02235649 |
Other study ID # | 13/LO/1791 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | June 2017 |
Verified date | December 2019 |
Source | Institute of Psychiatry, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Reduced social and community functioning is a predominant and enduring feature in people
experiencing severe mental illness such as psychosis. The large majority of interventions
(mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and
delusions) but poorly address functional and social consequences of the illness.
This study attempts to fill this gap by assessing the feasibility and acceptability of a
psychological intervention targeting social cognition deficit in people with psychosis. The
intervention is a group psychological treatment facilitated by a clinical psychologist
targeting competencies such as emotion recognition, social situation appraisal and guessing
people's intentions and mental states. The group therapy takes advantage of audiovisual
material to illustrate strategies and thinking styles that may help participants to overcome
difficulties in social settings.
A second objective of this study is to test a new method to measure social cognition. Recent
research showed that interview and performance based tests are poorly associated with every
day activity of people with schizophrenia. This study is planning to evaluate the feasibility
of new assessment methods for social cognition in everyday life using portable electronic
devices (Experience Sampling Method and an activity watch). These devices will be carried by
participants in their everyday life and will ask about feelings and levels of social
activities at random times and record basic physiological and activity levels.
Status | Completed |
Enrollment | 48 |
Est. completion date | June 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Diagnosis part of the psychosis spectrum (according to DSM-IV or DSM-V or ICD-10); age 18-65 yrs; good command of the English language; social engagement problems as evidenced by care coordinator report and number of hours spent in social activities per week lower than 10. Exclusion Criteria: Primary diagnosis of substance abuse disorder; change in antipsychotic medication in the last six weeks; significant learning difficulties (premorbid IQ lower than 70). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Institute of Psychiatry, King's College London | London |
Lead Sponsor | Collaborator |
---|---|
Institute of Psychiatry, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility and Acceptability | Number of sessions attended and number of drop out from therapy. Acceptability is assesses with a questionnaire designed for psychological interventions (Gledhill et al., 1998). | 10 weeks | |
Secondary | Effectiveness (i.e. social behaviour and social cognition) | 10 weeks |
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