| June 16, 2006 |
| March 16, 2009 |
| June 2005 |
| June 2010 (final data collection date for primary outcome measure) |
| Social Functioning: Independent Living Skills Survey (ILSS), PSR Toolkit, MASC [ Time Frame: Measured at baseline and Months 15 and 21 ] [ Designated as safety issue: No ] |
| Measured at Months 9, 15, and 21: Social Functioning |
| Complete list of historical versions of study NCT00338975 on ClinicalTrials.gov Archive Site |
- Neuropsychological functioning: MATRICS (BACS Category & Letter, BACS Symbol Coding, Trails A & B, WAIS letter Number Span, WMS Spatial Span, HVLT, BVMT), D-KEFS (20 questions, Card Sorting, Word Context), [ Time Frame: Measured at baseline and Months 15 and 21 ] [ Designated as safety issue: No ]
- Cognitive insight: Birchwood Insight Scale, Beck Cognitive Insight Scale [ Time Frame: Measured at baseline and Months 4.5, 9, 15, and 21 ] [ Designated as safety issue: No ]
- Psychotic symptoms: PANSS, PSY-RATS, Paranoia Scale, Beliefs About Voices Questionnaire (BAVQ-R) [ Time Frame: Measured at baseline and Months 4.5, 9, 15, and 21 ] [ Designated as safety issue: No ]
- Health services utilization: PSR Toolkit [ Time Frame: Measured at baseline and Months 9 and 21 ] [ Designated as safety issue: No ]
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- Measured at Months 9, 15, and 21: Neuropsychological functioning
- Cognitive insight
- Psychotic symptoms
- Health services utilization
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| |
| Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia |
| Cognitive Behavioral Skills Training for Schizophrenia |
This study will evaluate the effectiveness of cognitive behavioral social skills training versus supportive contact in improving social functioning in people with schizophrenia. |
Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia sometimes hear voices others don't hear, believe that others are broadcasting their thoughts to the world, or become convinced that others are plotting to harm them. These symptoms make it difficult for people with schizophrenia to interact normally and establish healthy social relationships with others. Cognitive behavioral social skills training (CBSST) is a group behavioral therapy intervention that focuses on improving cognitive and metacognitive impairments and social skills deficits that interfere with normal functioning in people with schizophrenia. Supportive contact (SC) is a group therapy intervention that focuses on helping people with schizophrenia to verbalize their problems or worries and to seek advice from fellow group members. This study will evaluate the effectiveness of CBSST versus SC in improving social functioning in people with schizophrenia. The study will also assess changes in cognition, psychotic symptoms, and use of psychiatric healthcare services.
Participants in this open label study will be randomly assigned to one of the following treatment groups: treatment as usual (TAU) plus CBSST or TAU plus SC. Both interventions will hold 2-hour therapy sessions weekly for 36 weeks. Groups receiving each intervention will not exceed ten people. CBSST will integrate cognitive therapy, social skills training, and neurocognitive compensatory aids. Cognitive therapy will help participants challenge unhelpful thoughts and build communication and problem-solving skills. Participants will receive workbooks that describe the skills and contain homework assignments. SC will focus on empowering participants to share problems, worries, or concerns with others who face similar issues. Participants will share advice amongst each other, but therapists will not teach skills. Outcomes will be assessed at Months 4.5, 9, 15, and 21 for all participants. |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Schizophrenia |
- Behavioral: Cognitive behavioral social skills training (CBSST)
- Behavioral: Goal oriented supportive contact (SC)
- Behavioral: Social Skills Training
- Behavioral: Goal Setting
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- Experimental: Participants will receive cognitive behavioral social skills training
- Active Comparator: Participants will receive goal oriented supported contact
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- Granholm E, McQuaid JR, McClure FS, Auslander LA, Perivoliotis D, Pedrelli P, Patterson T, Jeste DV. A randomized, controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia. Am J Psychiatry. 2005 Mar;162(3):520-9.
- Granholm E, McQuaid JR, McClure FS, Pedrelli P, Jeste DV. A randomized controlled pilot study of cognitive behavioral social skills training for older patients with schizophrenia. Schizophr Res. 2002 Jan 1;53(1-2):167-9. No abstract available.
- McQuaid JR, Granholm E, McClure FS, Roepke S, Pedrelli P, Patterson TL, Jeste DV. Development of an integrated cognitive-behavioral and social skills training intervention for older patients with schizophrenia. J Psychother Pract Res. 2000 Summer;9(3):149-56.
- Brenner HD, Hodel B, Genner R, Roder V, Corrigan PW. Biological and cognitive vulnerability factors in schizophrenia: implications for treatment. Br J Psychiatry Suppl. 1992 Oct;(18):154-63. Review. No abstract available.
- Granholm E, McQuaid JR, McClure FS, Link PC, Perivoliotis D, Gottlieb JD, Patterson TL, Jeste DV. Randomized controlled trial of cognitive behavioral social skills training for older people with schizophrenia: 12-month follow-up. J Clin Psychiatry. 2007 May;68(5):730-7.
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| |
| Active, not recruiting |
| 240 |
| June 2010 |
| June 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder at any stage of illness
Exclusion Criteria:
- Level of care required at baseline interferes with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric illness, substance use, or physical illness)
- No case manager or care coordinator
- Medically or psychiatrically unstable for outpatient therapy
- Exposure to social skills training (SST), cognitive behavioral therapy (CBT), or dialectical behavioral therapy (DBT) within 5 years prior to study entry
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00338975 |
| Eric L. Granholm, PhD, Veterans Medical research Foundation |
| R01 MH071410, DSIR 83-ATAP |
| National Institute of Mental Health (NIMH) |
|
| Principal Investigator: |
Eric L. Granholm, PhD |
VA San Diego Healthcare System/University of California San Diego |
|
|
| National Institute of Mental Health (NIMH) |
| March 2009 |