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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Social Skills Training (CBSST)
Goal-focused supportive contact (GFSC)
Social Skills Training
Goal Setting
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Psychotic Disorders, Schizoaffective Disorder, Cognitive Behavioral Therapy, Social Skills Training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Cognitive Behavioral Social Skills Training (CBSST)

Goal-Focused Supportive Contact (GFSC)

Outcomes

Primary Outcome Measures

Social Functioning
Independent Living Skills Survey (ILSS), PSR Toolkit, Maryland Assessment of Social Competence (MASC)

Secondary Outcome Measures

Neuropsychological functioning
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
Birchwood Insight Scale, Beck Cognitive Insight Scale
Psychotic symptoms
Positive and Negative Syndrome Scale (PANSS), Psychotic Symptoms Rating Scales (PSY-RATS), Paranoia Scale, Beliefs About Voices Questionnaire (BAVQ-R)

Full Information

First Posted
June 16, 2006
Last Updated
June 1, 2015
Sponsor
Veterans Medical Research Foundation
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00338975
Brief Title
Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia
Official Title
Cognitive Behavioral Skills Training for Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Psychotic Disorders, Schizoaffective Disorder, Cognitive Behavioral Therapy, Social Skills Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive Behavioral Social Skills Training (CBSST)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Goal-Focused Supportive Contact (GFSC)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Social Skills Training (CBSST)
Other Intervention Name(s)
CBT, SST
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Goal-focused supportive contact (GFSC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Other Intervention Name(s)
SST
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Goal Setting
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Social Functioning
Description
Independent Living Skills Survey (ILSS), PSR Toolkit, Maryland Assessment of Social Competence (MASC)
Time Frame
Measured at baseline and Months 9 and 21
Secondary Outcome Measure Information:
Title
Neuropsychological functioning
Description
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)
Time Frame
Measured at baseline and Months 9 and 21
Title
Cognitive insight
Description
Birchwood Insight Scale, Beck Cognitive Insight Scale
Time Frame
Measured at baseline and Months 4.5, 9, 15, and 21
Title
Psychotic symptoms
Description
Positive and Negative Syndrome Scale (PANSS), Psychotic Symptoms Rating Scales (PSY-RATS), Paranoia Scale, Beliefs About Voices Questionnaire (BAVQ-R)
Time Frame
Measured at baseline and Months 4.5, 9, 15, and 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L. Granholm, PhD
Organizational Affiliation
VA San Diego Healthcare System/University of California San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15741469
Citation
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. doi: 10.1176/appi.ajp.162.3.520.
Results Reference
background
PubMed Identifier
11728848
Citation
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. doi: 10.1016/s0920-9964(00)00186-9. No abstract available.
Results Reference
background
PubMed Identifier
10896740
Citation
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.
Results Reference
background
PubMed Identifier
1389037
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
17503982
Citation
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. doi: 10.4088/jcp.v68n0510.
Results Reference
background
PubMed Identifier
24911420
Citation
Granholm E, Holden J, Link PC, McQuaid JR. Randomized clinical trial of cognitive behavioral social skills training for schizophrenia: improvement in functioning and experiential negative symptoms. J Consult Clin Psychol. 2014 Dec;82(6):1173-85. doi: 10.1037/a0037098. Epub 2014 Jun 9.
Results Reference
derived

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

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