NCT00391677

Brief Summary

This study will evaluate the effectiveness of attention shaping procedures in improving attentiveness and learning abilities in people undergoing psychosocial skills training treatment for schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

4.4 years

First QC Date

October 20, 2006

Last Update Submit

September 27, 2012

Conditions

Schizophrenia

Keywords

Cognitive RehabilitationBehavior Therapy

Outcome Measures

Primary Outcomes (5)

  • Observational ratings of in-group attentiveness

    Measured two times per week for 16 weeks

  • Observational ratings of in-group attentiveness in non-study groups

    Measured at Month 6 follow-up

  • Changes in knowledge of information about social skills taught in the study

    Measured at pre- and post-treatment and at Month 6 follow-up

  • Changes in ability to demonstrate behavioral skills taught in the study

    Measured at pre- and post-treatment and at Month 6 follow-up

  • Level of social functioning

    Measured at pre- and post-treatment and at Month 6 follow-up

Secondary Outcomes (3)

  • Self-efficacy

    Measured at pre- and post-treatment and at Month 6 follow-up

  • Working alliance

    Measured at pre- and post-treatment and at Month 6 follow-up

  • Satisfaction with treatment

    Measured at pre- and post-treatment and at Month 6 follow-up

Study Arms (2)

1

EXPERIMENTAL

Participants will receive social skills training with attention shaping procedures

Behavioral: Social skills training with attention shaping procedures

2

ACTIVE COMPARATOR

Participants will receive social skills training without attention shaping procedures

Behavioral: Social skills training without attention shaping

Interventions

Social skills training with attention shaping proceduresBEHAVIORAL

Social skills training with attention shaping procedures includes behavioral procedures to increase the frequency, intensity, and duration of attentive behaviors and to reduce the frequency of inattentive behaviors.

1
Social skills training without attention shapingBEHAVIORAL

Social skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures.

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia, as confirmed by a diagnostic interview
  • Has experienced difficulty paying attention while in groups during a treatment program, as determined by program staff
  • Has experienced problems with social skills, as determined by program staff and study clinicians
  • Social skill deficits, as determined by study clinicians

You may not qualify if:

  • Diagnosis of mental retardation (including borderline or mild mental retardation)
  • Diagnosis of autism, Asperger's syndrome, or another childhood disorder involving learning or relating to other people
  • History of a neurological disorder, including epilepsy, traumatic brain injury with loss of consciousness, coma, stroke, Parkinson's disease, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Behavioral HealthCare

Monmouth Junction, New Jersey, 08852, United States

Location

University Behavioral HealthCare

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (2)

  • Silverstein SM, Hatashita-Wong M, Solak BA, Uhlhaas P, Landa Y, Wilkniss SM, Goicochea C, Carpiniello K, Schenkel LS, Savitz A, Smith TE. Effectiveness of a two-phase cognitive rehabilitation intervention for severely impaired schizophrenia patients. Psychol Med. 2005 Jun;35(6):829-37. doi: 10.1017/s0033291704003356.

    PMID: 15997603BACKGROUND

  • Silverstein SM, Spaulding WD, Menditto AA, Savitz A, Liberman RP, Berten S, Starobin H. Attention shaping: a reward-based learning method to enhance skills training outcomes in schizophrenia. Schizophr Bull. 2009 Jan;35(1):222-32. doi: 10.1093/schbul/sbm150. Epub 2008 Jan 22.

    PMID: 18212327BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Steven M. Silverstein, PhD

    University of Medicine and Dentistry of New Jersey

    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
SPONSOR

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 24, 2006

Study Start

January 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

US(2)