NCT02181777

Brief Summary

The purpose of this study is to assess the feasibility of a social skills training group for people with psychosis.

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

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

July 2, 2014

Last Update Submit

August 31, 2021

Conditions

Keywords

PsychosisSchizophreniaSocial SkillsTherapy

Outcome Measures

Primary Outcomes (2)

  • Therapy drop-out rate

    8 weeks post randomisation

  • Number of therapy session attended

    8 weeks post randomisation

Study Arms (2)

GRASP

EXPERIMENTAL

GRoup trAining for Social skills in Psychosis

Behavioral: GRASP

Standard care

ACTIVE COMPARATOR

Treatment as usual as provided by care team

Behavioral: Standard care

Interventions

GRASPBEHAVIORAL

GRoup trAining for Social skills in Psychosis

GRASP
Standard careBEHAVIORAL

Treatment as usual

Standard care

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)
  • 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)

Kings College London

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 17412842BACKGROUND

Related Links

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaSocial Skills

Interventions

Hand StrengthStandard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Muscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Matteo Cella, DClinPsy

    Institute of Psychiatry

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 4, 2014

Study Start

March 1, 2014

Primary Completion

December 31, 2015

Study Completion

November 30, 2016

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations