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Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00338975
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric L. Granholm, San Diego Veterans Healthcare System

Tracking Information
First Submitted Date  ICMJE June 16, 2006
First Posted Date  ICMJE June 20, 2006
Last Update Posted Date June 3, 2015
Study Start Date  ICMJE June 2005
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Social Functioning [ Time Frame: Measured at baseline and Months 9 and 21 ]
Independent Living Skills Survey (ILSS), PSR Toolkit, Maryland Assessment of Social Competence (MASC)
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2006)
Measured at Months 9, 15, and 21: Social Functioning
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Neuropsychological functioning [ Time Frame: Measured at baseline and Months 9 and 21 ]
    Delis-Kaplan Executive Function System (D-KEFS; 20 Questions, Card Sort, Word Context), Trails A & B, Letter Number Sequencing, Wechsler Memory Scale (WMS) Spatial Span, Hopkins Verbal Learning Test (HVLT), Brief Visuospatial Memory Test (BVMT)
  • Cognitive insight [ Time Frame: Measured at baseline and Months 4.5, 9, 15, and 21 ]
    Birchwood Insight Scale, Beck Cognitive Insight Scale
  • Psychotic symptoms [ Time Frame: Measured at baseline and Months 4.5, 9, 15, and 21 ]
    Positive and Negative Syndrome Scale (PANSS), Psychotic Symptoms Rating Scales (PSY-RATS), Paranoia Scale, Beliefs About Voices Questionnaire (BAVQ-R)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2006)
  • Measured at Months 9, 15, and 21: Neuropsychological functioning
  • Cognitive insight
  • Psychotic symptoms
  • Health services utilization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia
Official Title  ICMJE Cognitive Behavioral Skills Training for Schizophrenia
Brief Summary This study evaluated the effectiveness of Cognitive Behavioral Social Skills Training versus goal-focused supportive contact in improving social functioning in people with schizophrenia.
Detailed Description

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. Goal-focused supportive contact (GFSC) 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 evaluated the effectiveness of CBSST versus GFSC in improving social functioning in people with schizophrenia. The study will assessed changes in cognition, psychotic symptoms, and use of psychiatric healthcare services.

Participants in this open label study were randomly assigned to one of the following treatment groups: treatment as usual (TAU) plus CBSST or TAU plus GFSC. Both interventions consist of 2-hour therapy sessions weekly for 36 weeks. Groups receiving each intervention do not exceed ten people. CBSST integrates cognitive therapy, social skills training, and neurocognitive compensatory aids. Cognitive therapy helps participants challenge unhelpful thoughts and build communication and problem-solving skills. Participants receive workbooks that describe the skills and contain homework assignments. GFSC focuses on empowering participants to share problems, worries, or concerns with others who face similar issues. Participants share advice with each other, but therapists do not teach skills. Outcomes were be assessed at Months 4.5, 9, 15, and 21 for all participants.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
    There are 36 weekly group sessions, each session is 2 hours in length, with a half-hour break after the first hour. The intervention integrates CBT and SST techniques and neurocognitive compensatory aids. All participants are asked to identify a goal. The SST components are based, in part, on a pre-packaged SST intervention available from Psychiatric Rehabilitation Consultants. The CBT components are based on techniques developed for CBT in general and techniques developed specifically for patients with schizophrenia. Cognitive therapy is combined with role-play practice of communication skills and problem-solving training.
    Other Names:
    • CBT
    • SST
  • Behavioral: Goal-focused supportive contact (GFSC)
    There are 36 weekly group sessions, each 2 hours in length, with a half-hour break after the first hour. GFSC has a number of specific goals and interventions, including providing a safe environment where the patient can discuss her/his feelings and concerns; to validate these feelings and concerns; and to provide support and guidance to the client so that she/he can make progress to solving problems or alleviating concerns and worries. Psychotic symptoms and cognition are not directly targeted. Therapists utilize "non-specific" therapeutic techniques, including providing unconditional positive regard, reflective listening, encouraging, paraphrasing, and summarizing. Therapists do not develop a formulation or teach skills.
  • Behavioral: Social Skills Training
    The SST components are based, in part, on a pre-packaged SST intervention available from Psychiatric Rehabilitation Consultants. Participants engage in role plays and problem solving.
    Other Name: SST
  • Behavioral: Goal Setting
    All participants are asked to identify a personally meaningful goal as soon as possible in therapy. Over the 36 weeks, participants in CBSST learn skills related to goal attainment, while participants in GFSC do not receive skills aimed at goal attainment, but are encouraged to discuss their goals .
Study Arms  ICMJE
  • Experimental: 1
    Cognitive Behavioral Social Skills Training (CBSST)
    Interventions:
    • Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
    • Behavioral: Social Skills Training
    • Behavioral: Goal Setting
  • Active Comparator: 2
    Goal-Focused Supportive Contact (GFSC)
    Interventions:
    • Behavioral: Goal-focused supportive contact (GFSC)
    • Behavioral: Goal Setting
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2013)
179
Original Enrollment  ICMJE
 (submitted: June 16, 2006)
240
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00338975
Other Study ID Numbers  ICMJE R01MH071410( U.S. NIH Grant/Contract )
R01MH071410 ( U.S. NIH Grant/Contract )
DSIR 83-ATAP ( Other Identifier: NIMH/DSIR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric L. Granholm, San Diego Veterans Healthcare System
Study Sponsor  ICMJE Veterans Medical Research Foundation
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Eric L. Granholm, PhD VA San Diego Healthcare System/University of California San Diego
PRS Account Veterans Medical Research Foundation
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP