| October 20, 2006 |
| March 9, 2009 |
| January 2007 |
| May 2011 (final data collection date for primary outcome measure) |
- 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 ]
|
- Measured 6 months post-intervention: 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
|
| Complete list of historical versions of study NCT00391677 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Measured 6 months post-intervention: Self-efficacy
- Working alliance
- Satisfaction with treatment
|
| |
| Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia |
| Effectiveness Trial of Attention Shaping for Schizophrenia |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Schizophrenia |
- Behavioral: Social skills training with attention shaping procedures
- Behavioral: Social skills training without attention shaping
|
- Experimental: Participants will receive social skills training with attention shaping procedures
- Active Comparator: Participants will receive social skills training without attention shaping procedures
|
- 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.
- 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. Epub 2008 Jan 22.
|
| |
| Recruiting |
| 100 |
| December 2011 |
| May 2011 (final data collection date for primary outcome measure) |
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)
|
| Both |
| 18 Years to 55 Years |
| No |
|
|
| United States |
| |
| NCT00391677 |
| Steven M. Silverstein, PhD, University of Medicine and Dentistry of New Jersey |
| R01 MH074650, DATR A2-A1SZ |
| National Institute of Mental Health (NIMH) |
|
| Principal Investigator: |
Steven M. Silverstein, PhD |
University of Medicine and Dentistry New Jersey |
|
|
| National Institute of Mental Health (NIMH) |
| March 2009 |