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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2019
Source Institute of Psychiatry, London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social Cognition therapy ( Psychological Therapy)


Locations

Country Name City State
United Kingdom Institute of Psychiatry, King's College London London

Sponsors (1)

Lead Sponsor Collaborator
Institute of Psychiatry, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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