Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social skills training with attention shaping procedures
Social skills training without attention shaping
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Rehabilitation, Behavior Therapy
Eligibility 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)
Sites / Locations
- University Behavioral HealthCare
- University Behavioral HealthCare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive social skills training with attention shaping procedures
Participants will receive social skills training without attention shaping procedures
Outcomes
Primary Outcome Measures
Observational ratings of in-group attentiveness
Observational ratings of in-group attentiveness in non-study groups
Changes in knowledge of information about social skills taught in the study
Changes in ability to demonstrate behavioral skills taught in the study
Level of social functioning
Secondary Outcome Measures
Self-efficacy
Working alliance
Satisfaction with treatment
Full Information
NCT ID
NCT00391677
First Posted
October 20, 2006
Last Updated
September 27, 2012
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00391677
Brief Title
Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia
Official Title
Effectiveness Trial of Attention Shaping for Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Cognitive Rehabilitation, Behavior Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive social skills training with attention shaping procedures
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive social skills training without attention shaping procedures
Intervention Type
Behavioral
Intervention Name(s)
Social skills training with attention shaping procedures
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social skills training without attention shaping
Intervention Description
Social skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures.
Primary Outcome Measure Information:
Title
Observational ratings of in-group attentiveness
Time Frame
Measured two times per week for 16 weeks
Title
Observational ratings of in-group attentiveness in non-study groups
Time Frame
Measured at Month 6 follow-up
Title
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
Title
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
Title
Level of social functioning
Time Frame
Measured at pre- and post-treatment and at Month 6 follow-up
Secondary Outcome Measure Information:
Title
Self-efficacy
Time Frame
Measured at pre- and post-treatment and at Month 6 follow-up
Title
Working alliance
Time Frame
Measured at pre- and post-treatment and at Month 6 follow-up
Title
Satisfaction with treatment
Time Frame
Measured at pre- and post-treatment and at Month 6 follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Silverstein, PhD
Organizational Affiliation
University of Medicine and Dentistry of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Behavioral HealthCare
City
Monmouth Junction
State/Province
New Jersey
ZIP/Postal Code
08852
Country
United States
Facility Name
University Behavioral HealthCare
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15997603
Citation
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.
Results Reference
background
PubMed Identifier
18212327
Citation
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.
Results Reference
background
Learn more about this trial
Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia
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