Clinical trial NCT00391677: Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia
Official title: Effectiveness Trial of Attention Shaping for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Cognitive Rehabilitation
Behavior Therapy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Observational ratings of in-group attentiveness
timeFrame: Measured two times per week for 16 weeks
measure: Observational ratings of in-group attentiveness in non-study groups
timeFrame: Measured at Month 6 follow-up
measure: Changes in knowledge of information about social skills taught in the study
timeFrame: Measured at pre- and post-treatment and at Month 6 follow-up
measure: Changes in ability to demonstrate behavioral skills taught in the study
timeFrame: Measured at pre- and post-treatment and at Month 6 follow-up
measure: Level of social functioning
timeFrame: Measured at pre- and post-treatment and at Month 6 follow-up
Secondary outcomes:
measure: Self-efficacy
timeFrame: Measured at pre- and post-treatment and at Month 6 follow-up
measure: Working alliance
timeFrame: Measured at pre- and post-treatment and at Month 6 follow-up
measure: Satisfaction with treatment
timeFrame: Measured at pre- and post-treatment and at Month 6 follow-up
Other outcomes:
Locations:
city: Monmouth Junction
country: United States
facility: University Behavioral HealthCare
state: New Jersey
city: New Brunswick
country: United States
facility: University Behavioral HealthCare
state: New Jersey
Study officials:
affiliation: University of Medicine and Dentistry of New Jersey
name: Steven M. Silverstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.