Focus of StudyNCT02235649
Exploring the Feasibility of Social Skills Training in People With Psychosis
A study testing Social Cognition therapy ( Psychological Therapy) in people with Focus of Study, run by Institute of Psychiatry, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focus of Study
- What is being tested?
- Social Cognition therapy ( Psychological Therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Primary diagnosis of substance abuse disorder; change in antipsychotic medication in the last six weeks; significant learning difficulties (premorbid IQ lower than 70).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Psychiatry, King's College London
London, SE5 8AF
About this study
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.
- Conditions
- Focus of Study
- Being tested
- Social Cognition therapy ( Psychological Therapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognition therapy ( Psychological Therapy)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| TAU | No intervention | Treatment as usual |
| SOC+TAU | Active comparator | Social Cognition intervention + Treatment as Usual Receives: Behavioral: Social Cognition therapy ( Psychological Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 weeks
Secondary outcomes (1)
Effectiveness (i.e. social behaviour and social cognition)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Cella, Institute of Psychiatry, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235649
- Sponsor's protocol ID
- 13/LO/1791
- Status last verified
- Dec 2019
- First submitted
- 1 Apr 2014
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of Social Skills Training in People With Psychosis
- ClinicalTrials.gov ID
- NCT02235649
- Acronym / sponsor ID
- 13/LO/1791
- Conditions
- Focus of Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Institute of Psychiatry, LondonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU | No intervention | –Treatment as usual |
| SOC+TAU | Active comparator | Behavioral: Social Cognition therapy ( Psychological Therapy)Social Cognition intervention + Treatment as Usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Primary diagnosis of substance abuse disorder; change in antipsychotic medication in the last six weeks; significant learning difficulties (premorbid IQ lower than 70).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Cognition therapy ( Psychological Therapy) | Behavioural | SOC+TAU |
Primary outcome
Feasibility and Acceptability
Time frame: 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).
1 secondary outcome
Effectiveness (i.e. social behaviour and social cognition)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition therapy ( Psychological Therapy) in people with Focus of Study, run by Institute of Psychiatry, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.