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.

Study Overview

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

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Monmouth Junction, New Jersey, United States, 08852
        • University Behavioral Healthcare
      • New Brunswick, New Jersey, United States, 08901
        • University Behavioral Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
Social skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures.

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
Measured two times per week for 16 weeks
Observational ratings of in-group attentiveness in non-study groups
Time Frame: Measured at Month 6 follow-up
Measured at Month 6 follow-up
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
Measured at pre- and post-treatment and at Month 6 follow-up
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
Measured at pre- and post-treatment and at Month 6 follow-up
Level of social functioning
Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up
Measured at pre- and post-treatment and at Month 6 follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-efficacy
Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up
Measured at pre- and post-treatment and at Month 6 follow-up
Working alliance
Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up
Measured at pre- and post-treatment and at Month 6 follow-up
Satisfaction with treatment
Time Frame: Measured at pre- and post-treatment and at Month 6 follow-up
Measured at pre- and post-treatment and at Month 6 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Steven M. Silverstein, PhD, University of Medicine and Dentistry of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

October 20, 2006

First Submitted That Met QC Criteria

October 20, 2006

First Posted (ESTIMATE)

October 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2012

Last Update Submitted That Met QC Criteria

September 27, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

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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