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Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00391677
First received: October 20, 2006
Last updated: September 27, 2012
Last verified: September 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness Trial of Attention Shaping for Schizophrenia

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

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 ]

Enrollment: 120
Study Start Date: January 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
University Behavioral HealthCare
Monmouth Junction, New Jersey, United States, 08852
University Behavioral HealthCare
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Steven M. Silverstein, PhD University of Medicine and Dentistry of New Jersey
  More Information

Publications:
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00391677     History of Changes
Other Study ID Numbers: R01 MH074650, R01MH074650, DATR A2-A1SZ
Study First Received: October 20, 2006
Last Updated: September 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
Cognitive Rehabilitation
Behavior Therapy

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014