NCT02235649

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

3.1 years

First QC Date

April 1, 2014

Last Update Submit

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 INTERVENTION

Treatment as usual

SOC+TAU

ACTIVE COMPARATOR

Social Cognition intervention + Treatment as Usual

Behavioral: Social Cognition therapy ( Psychological Therapy)

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations