Exploring the Feasibility of Social Skills Training in People With Psychosis

Sponsor

Institute of Psychiatry, London (Other)

Overall Status

Completed

CT.gov ID

NCT02235649

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Focus of Study	Behavioral: Social Cognition therapy ( Psychological Therapy)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: TAU Treatment as usual
Active Comparator: SOC+TAU Social Cognition intervention + Treatment as Usual	Behavioral: Social Cognition therapy ( Psychological Therapy)

Arm

Intervention/Treatment

No Intervention: TAU

Treatment as usual

Active Comparator: SOC+TAU

Social Cognition intervention + Treatment as Usual

Behavioral: Social Cognition therapy ( Psychological Therapy)

Outcome Measures

Primary Outcome Measures

Feasibility and Acceptability [10 weeks]
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).

Secondary Outcome Measures

Effectiveness (i.e. social behaviour and social cognition) [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Psychiatry, King's College London	London		United Kingdom	SE5 8AF

Sponsors and Collaborators

Institute of Psychiatry, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matteo Cella, Lecturer in Clinical Psychology, Institute of Psychiatry, London

ClinicalTrials.gov Identifier:

NCT02235649

Other Study ID Numbers:

13/LO/1791

First Posted:

Sep 10, 2014

Last Update Posted:

Dec 5, 2019

Last Verified:

Dec 1, 2019

Study Results

No Results Posted as of Dec 5, 2019