Exploring the Feasibility of Social Skills Training in People With Psychosis
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 5, 2019
December 1, 2019
3.1 years
April 1, 2014
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Effectiveness (i.e. social behaviour and social cognition)
10 weeks
Study Arms (2)
TAU
NO INTERVENTIONTreatment as usual
SOC+TAU
ACTIVE COMPARATORSocial Cognition intervention + Treatment as Usual
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Primary diagnosis of substance abuse disorder; change in antipsychotic medication in the last six weeks; significant learning difficulties (premorbid IQ lower than 70).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Psychiatry, King's College London
London, SE5 8AF, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer in Clinical Psychology
Study Record Dates
First Submitted
April 1, 2014
First Posted
September 10, 2014
Study Start
March 1, 2014
Primary Completion
April 1, 2017
Study Completion
June 1, 2017
Last Updated
December 5, 2019
Record last verified: 2019-12