SchizophreniaNCT00391677
Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia
A study testing Social skills training with attention shaping procedures and Social skills training without attention shaping in people with Schizophrenia, run by University of Medicine and Dentistry of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Social skills training with attention shaping procedures and Social skills training without attention shaping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Behavioral HealthCare
Monmouth Junction, New Jersey, 08852
University Behavioral HealthCare
New Brunswick, New Jersey, 08901
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Social skills training with attention shaping procedures, Social skills training without attention shaping
- Keywords
- Cognitive Rehabilitation, Behavior Therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social skills training with attention shaping proceduresBehavioural
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.
Social skills training without attention shapingBehavioural
Social skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive social skills training with attention shaping procedures Receives: Behavioral: Social skills training with attention shaping procedures |
| 2 | Active comparator | Participants will receive social skills training without attention shaping procedures Receives: Behavioral: Social skills training without attention shaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational ratings of in-group attentiveness
Measured: Measured two times per week for 16 weeks
Observational ratings of in-group attentiveness in non-study groups
Measured: Measured at Month 6 follow-up
Changes in knowledge of information about social skills taught in the study
Measured: Measured at pre- and post-treatment and at Month 6 follow-up
Changes in ability to demonstrate behavioral skills taught in the study
Measured: Measured at pre- and post-treatment and at Month 6 follow-up
Level of social functioning
Measured: Measured at pre- and post-treatment and at Month 6 follow-up
Secondary outcomes (3)
Self-efficacy
Measured: Measured at pre- and post-treatment and at Month 6 follow-up
Working alliance
Measured: Measured at pre- and post-treatment and at Month 6 follow-up
Satisfaction with treatment
Measured: Measured at pre- and post-treatment and at Month 6 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Steven M. Silverstein, PhD, Principal investigator, University of Medicine and Dentistry of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391677
- Sponsor's protocol ID
- R01MH074650
- Other IDs
- R01MH074650, DATR A2-A1SZ
- Status last verified
- Sep 2012
- First submitted
- 20 Oct 2006
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15997603Silverstein 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.
PubMed 18212327
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Trial of Attention Shaping for Schizophrenia
- ClinicalTrials.gov ID
- NCT00391677
- Acronym / sponsor ID
- R01MH074650
- Conditions
- Schizophrenia
- Keywords
- Cognitive Rehabilitation, Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Social skills training with attention shaping proceduresParticipants will receive social skills training with attention shaping procedures |
| 2 | Active comparator | Behavioral: Social skills training without attention shapingParticipants will receive social skills training without attention shaping procedures |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social skills training with attention shaping proceduresSocial 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. | Behavioural | 1 |
| Social skills training without attention shapingSocial skills training without attention shaping is based on the UCLA Basic Conversation Skills Training Module, used without attention shaping procedures. | Behavioural | 2 |
Primary outcome
Observational ratings of in-group attentiveness
Time frame: 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
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
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
Level of social functioning
Time frame: Measured at pre- and post-treatment and at Month 6 follow-up
3 secondary outcomes
Self-efficacy
Time frame: 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
Satisfaction with treatment
Time frame: Measured at pre- and post-treatment and at Month 6 follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Background: PubMed 15997603Silverstein 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.
- Background: PubMed 18212327Silverstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M. Silverstein, PhD principal investigator
University of Medicine and Dentistry of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social skills training with attention shaping procedures and Social skills training without attention shaping in people with Schizophrenia, run by University of Medicine and Dentistry of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational ratings of in-group attentiveness (time frame: Measured two times per week for 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2012.