Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00391677

Purpose

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.

Condition	Intervention
Schizophrenia	Behavioral: Social skills training with attention shaping procedures Behavioral: Social skills training without attention shaping

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Effectiveness Trial of Attention Shaping for Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Observational ratings of in-group attentiveness [ Time Frame: Measured two times per week for 16 weeks ] [ Designated as safety issue: No ]
Observational ratings of in-group attentiveness in non-study groups [ Time Frame: Measured at Month 6 follow-up ] [ Designated as safety issue: No ]
Changes in knowledge of information about social skills taught in the study [ Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up ] [ Designated as safety issue: No ]
Changes in ability to demonstrate behavioral skills taught in the study [ Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up ] [ Designated as safety issue: No ]
Level of social functioning [ Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self-efficacy [ Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up ] [ Designated as safety issue: No ]
Working alliance [ Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up ] [ Designated as safety issue: No ]
Satisfaction with treatment [ Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive social skills training with attention shaping procedures	Behavioral: Social skills training with attention shaping procedures 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.
2: Active Comparator Participants will receive social skills training without attention shaping procedures	Behavioral: Social skills training without attention shaping Social skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures.

Detailed Description:

Schizophrenia is a disabling mental disorder that can interfere with a person's ability to function both alone and in social situations. Various treatments have been effective in treating schizophrenia, including antipsychotic medications and cognitive therapy. Psychosocial skills training, a type of cognitive therapy, is often used to help people with schizophrenia cope with their condition and improve social functioning in day-to-day life. However, many individuals with schizophrenia experience difficulty paying attention, and this is a significant barrier to successful outcomes in psychosocial skills training interventions. Attention shaping procedures (ASP) is a behavioral intervention that helps individuals with impaired attention capacities to benefit from skills-based treatment. This study will evaluate the effectiveness of ASP in improving attentiveness and learning abilities in people undergoing psychosocial skills training treatment for schizophrenia.

Participants in this 5-month, single-blind study will be randomly assigned to ASP plus basic conversation skills training (BCS), which is a social skills training group, or BCS alone. Training sessions for both groups will be held when participants attend regular hospital visits. During the first month, participants will complete two sessions of interviews, self-report scales, and social and cognitive functional assessments. Over the next 3 months, training sessions for both groups will occur twice a week for approximately 1 hour. ASP sessions will focus on setting goals and increasing the quality and duration of participants' attentiveness during psychosocial interventions. BCS will train participants in the following five skill areas: recognizing verbal and non-verbal cues; starting a friendly conversation; keeping conversation going; ending a conversation politely; and incorporating all of these skills together. During the last month, participants will attend two interview sessions lasting approximately 4 hours each. One follow-up session will occur 6 months after completing the intervention.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Diagnosis of active substance abuse (history of a substance abuse disorder without a current substance abuse problem will not be a criterion for exclusion)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391677

Contacts

Contact: Steven M. Silverstein, PhD	732-235-5149	silvers1@umdnj.edu
Contact: Igor Malinovski	732-235-5148	malinovsky01@icqmail.com

Locations

United States, New Jersey
University Behavioral HealthCare	Recruiting
New Brunswick, New Jersey, United States, 08901
Principal Investigator: Steven M. Silverstein, PhD
University Behavioral HealthCare	Recruiting
Monmouth Junction, New Jersey, United States, 08852
Contact: Steven M. Silverstein, PhD 732-235-5149 silvers1@umdnj.edu
Principal Investigator: Steven M. Silverstein, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Steven M. Silverstein, PhD

University of Medicine and Dentistry New Jersey

More Information

Publications:

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.

Responsible Party:	University of Medicine and Dentistry of New Jersey ( Steven M. Silverstein, PhD )
Study ID Numbers:	R01 MH74650, DATR A2-A1SZ
Study First Received:	October 20, 2006
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00391677
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Cognitive Rehabilitation
Behavior Therapy

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009