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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eric L. Granholm, San Diego Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00338975
First received: June 16, 2006
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

This study evaluated the effectiveness of Cognitive Behavioral Social Skills Training versus goal-focused supportive contact in improving social functioning in people with schizophrenia.


Condition Intervention
Schizophrenia
Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
Behavioral: Goal-focused supportive contact (GFSC)
Behavioral: Social Skills Training
Behavioral: Goal Setting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Skills Training for Schizophrenia

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Social Functioning [ Time Frame: Measured at baseline and Months 9 and 21 ] [ Designated as safety issue: No ]
    Independent Living Skills Survey (ILSS), PSR Toolkit, Maryland Assessment of Social Competence (MASC)


Secondary Outcome Measures:
  • Neuropsychological functioning [ Time Frame: Measured at baseline and Months 9 and 21 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Birchwood Insight Scale, Beck Cognitive Insight Scale

  • Psychotic symptoms [ Time Frame: Measured at baseline and Months 4.5, 9, 15, and 21 ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale (PANSS), Psychotic Symptoms Rating Scales (PSY-RATS), Paranoia Scale, Beliefs About Voices Questionnaire (BAVQ-R)


Enrollment: 179
Study Start Date: June 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cognitive Behavioral Social Skills Training (CBSST)
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: 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 .
Active Comparator: 2
Goal-Focused Supportive Contact (GFSC)
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: 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 .

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338975

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Investigators
Principal Investigator: Eric L. Granholm, PhD VA San Diego Healthcare System/University of California San Diego
  More Information

Publications:
Responsible Party: Eric L. Granholm, Professor of Psychiatry, UCSD, San Diego Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT00338975     History of Changes
Other Study ID Numbers: R01 MH071410, R01MH071410, DSIR 83-ATAP
Study First Received: June 16, 2006
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Veterans Medical Research Foundation:
Psychotic Disorders
Schizoaffective Disorder
Cognitive Behavioral Therapy
Social Skills Training

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014