- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00338975
Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia
Cognitive Behavioral Skills Training for Schizophrenia
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92161
- VA San Diego Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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:
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 Names:
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)
|
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 .
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Measured at baseline and Months 9 and 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Measured at baseline and Months 9 and 21
|
Cognitive insight
Time Frame: Measured at baseline and Months 4.5, 9, 15, and 21
|
Birchwood Insight Scale, Beck Cognitive Insight Scale
|
Measured at baseline and Months 4.5, 9, 15, and 21
|
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)
|
Measured at baseline and Months 4.5, 9, 15, and 21
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eric L. Granholm, PhD, VA San Diego Healthcare System/University of California San Diego
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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. No abstract available.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH071410 (U.S. NIH Grant/Contract)
- DSIR 83-ATAP (NIMH/DSIR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Cognitive Behavioral Social Skills Training (CBSST)
-
US Department of Veterans AffairsTerminatedSchizophrenia | AgingUnited States
-
VA Office of Research and DevelopmentRecruitingSerious Mental IllnessUnited States
-
US Department of Veterans AffairsCompletedPsychotic Disorders | Schizophrenia | Schizoaffective DisorderUnited States
-
University of California, San DiegoNational Institute of Mental Health (NIMH)CompletedSchizophreniaUnited States
-
Veterans Medical Research FoundationNational Institute of Mental Health (NIMH)Completed
-
University of MinnesotaMinnesota Medical FoundationCompleted
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
University of CalgaryUniversity of California, San Diego; The Zucker Hillside HospitalCompletedAt Risk of PsychosisCanada
-
VA Office of Research and DevelopmentCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
University of PittsburghNational Institute of Mental Health (NIMH)Completed