- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00391677
Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia
Effectiveness Trial of Attention Shaping for Schizophrenia
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Monmouth Junction, New Jersey, United States, 08852
- University Behavioral Healthcare
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New Brunswick, New Jersey, United States, 08901
- University Behavioral Healthcare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Participants will receive social skills training with attention shaping procedures
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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.
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ACTIVE_COMPARATOR: 2
Participants will receive social skills training without attention shaping procedures
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Social skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Observational ratings of in-group attentiveness
Time Frame: Measured two times per week for 16 weeks
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Measured two times per week for 16 weeks
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Observational ratings of in-group attentiveness in non-study groups
Time Frame: Measured at Month 6 follow-up
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Measured at Month 6 follow-up
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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
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Measured at pre- and post-treatment and at Month 6 follow-up
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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
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Measured at pre- and post-treatment and at Month 6 follow-up
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Level of social functioning
Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up
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Measured at pre- and post-treatment and at Month 6 follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-efficacy
Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up
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Measured at pre- and post-treatment and at Month 6 follow-up
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Working alliance
Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up
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Measured at pre- and post-treatment and at Month 6 follow-up
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Satisfaction with treatment
Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up
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Measured at pre- and post-treatment and at Month 6 follow-up
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven M. Silverstein, PhD, University of Medicine and Dentistry of New Jersey
Publications and helpful links
General 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. doi: 10.1017/s0033291704003356.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH074650 (NIH)
- DATR A2-A1SZ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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