Psychotic DisordersGRASPNCT02181777
Group Training for Social Skills in Psychosis
A study testing GRASP in people with Psychotic Disorders, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the feasibility of a social skills training group for people with psychosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- GRASP
- 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 30 Nov 2016
- 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)
- 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.
About this study
Official title: Exploring the Feasibility of Social Skills Training in People With Psychosis.
The purpose of this study is to assess the feasibility of a social skills training group for people with psychosis.
Read the detailed description
This study is assessing the feasibility of a psychological intervention targeting social cognition problems in people with psychosis. The intervention is a group psychological treatment facilitated by a clinical psychologist. The group therapy takes advantage of audiovisual material and practical exercises to illustrate strategies and thinking styles that may help participants overcome difficulties in social settings.
A second objective of this study is to test a new method to measure social cognition by using portable devices. These devices will be carried by participants in their everyday life and will ask about their social activity levels at random times and record activity levels.
- Conditions
- Psychotic Disorders
- Being tested
- GRASP, Standard care
- Keywords
- Psychosis, Schizophrenia, Social Skills, Therapy
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRASPBehavioural
GRoup trAining for Social skills in Psychosis
Standard careBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| GRASP | Experimental | GRoup trAining for Social skills in Psychosis Receives: Behavioral: GRASP |
| Standard care | Active comparator | Treatment as usual as provided by care team Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy drop-out rate
Measured: 8 weeks post randomisation
Number of therapy session attended
Measured: 8 weeks post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startMar 2014
- Primary completion31 Dec 2015
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, South London and Maudsley NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Matteo Cella, King's College London
- Investigators
- Matteo Cella, DClinPsy, Principal investigator, Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181777
- Sponsor's protocol ID
- R&D2014/018
- Acronym
- GRASP
- Status last verified
- Aug 2021
- First submitted
- 2 Jul 2014
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Penn DL, Roberts DL, Combs D, Sterne A. Best practices: The development of the Social Cognition and Interaction Training program for schizophrenia spectrum disorders. Psychiatr Serv. 2007 Apr;58(4):449-51. doi: 10.1176/ps.2007.58.4.449.
PubMed 17412842
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. 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
- NCT02181777
- Acronym / sponsor ID
- GRASP / R&D2014/018
- Conditions
- Psychotic Disorders
- Keywords
- Psychosis, Schizophrenia, Social Skills, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, South London and Maudsley NHS Foundation Trust
- Study start
- Mar 2014
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 4 Jul 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.
The purpose of this study is to assess the feasibility of a social skills training group for people with psychosis.
Detailed description
This study is assessing the feasibility of a psychological intervention targeting social cognition problems in people with psychosis. The intervention is a group psychological treatment facilitated by a clinical psychologist. The group therapy takes advantage of audiovisual material and practical exercises to illustrate strategies and thinking styles that may help participants overcome difficulties in social settings.
A second objective of this study is to test a new method to measure social cognition by using portable devices. These devices will be carried by participants in their everyday life and will ask about their social activity levels at random times and record 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 |
|---|---|---|
| GRASP | Experimental | Behavioral: GRASPGRoup trAining for Social skills in Psychosis |
| Standard care | Active comparator | Behavioral: Standard careTreatment as usual as provided by care team |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis part of the psychosis spectrum (according to DSM-IV or DSM-V or ICD-10)
- 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 (3 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 |
|---|---|---|
| GRASPGRoup trAining for Social skills in Psychosis | Behavioural | GRASP |
| Standard careTreatment as usual | Behavioural | Standard care |
Primary outcome
Therapy drop-out rate
Time frame: 8 weeks post randomisation
Number of therapy session attended
Time frame: 8 weeks post randomisation
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 Sep 2021.
- Background: PubMed 17412842Penn DL, Roberts DL, Combs D, Sterne A. Best practices: The development of the Social Cognition and Interaction Training program for schizophrenia spectrum disorders. Psychiatr Serv. 2007 Apr;58(4):449-51. doi: 10.1176/ps.2007.58.4.449.
- Related InformationLink provided by the sponsor.
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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.
Matteo Cella, DClinPsy principal investigator
Institute of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRASP in people with Psychotic Disorders, run by King's College 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 3 inclusion and 3 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 Sep 2021. 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?
Therapy drop-out rate (time frame: 8 weeks post randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02181777, which also lists 1 linked publication.
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 Sep 2021.