SchizophreniaNCT00338975
Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia
A study testing Cognitive Behavioral Social Skills Training (CBSST), Goal-focused supportive contact (GFSC) and Social Skills Training in people with Schizophrenia, run by Veterans Medical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive Behavioral Social Skills Training (CBSST), Goal-focused supportive contact (GFSC) and Social Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder at any stage of illness
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: Cognitive Behavioral Skills Training for Schizophrenia
This study evaluated the effectiveness of Cognitive Behavioral Social Skills Training versus goal-focused supportive contact in improving social functioning in people with schizophrenia.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Cognitive Behavioral Social Skills Training (CBSST), Goal-focused supportive contact (GFSC), Social Skills Training, Goal Setting
- Keywords
- Psychotic Disorders, Schizoaffective Disorder, Cognitive Behavioral Therapy, Social Skills Training
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Social Skills Training (CBSST)Behavioural
Also called CBT, SST
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.
Goal-focused supportive contact (GFSC)Behavioural
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.
Social Skills TrainingBehavioural
Also called SST
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.
Goal SettingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cognitive Behavioral Social Skills Training (CBSST) Receives: Behavioral: Cognitive Behavioral Social Skills Training (CBSST); Behavioral: Social Skills Training; Behavioral: Goal Setting |
| 2 | Active comparator | Goal-Focused Supportive Contact (GFSC) Receives: Behavioral: Goal-focused supportive contact (GFSC); Behavioral: Goal Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Functioning
Independent Living Skills Survey (ILSS), PSR Toolkit, Maryland Assessment of Social Competence (MASC)
Measured: Measured at baseline and Months 9 and 21
Secondary outcomes (3)
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)
Measured: Measured at baseline and Months 9 and 21
Cognitive insight
Birchwood Insight Scale, Beck Cognitive Insight Scale
Measured: Measured at baseline and Months 4.5, 9, 15, and 21
Psychotic symptoms
Positive and Negative Syndrome Scale (PANSS), Psychotic Symptoms Rating Scales (PSY-RATS), Paranoia Scale, Beliefs About Voices Questionnaire (BAVQ-R)
Measured: Measured at baseline and Months 4.5, 9, 15, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2005
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Eric L. Granholm, San Diego Veterans Healthcare System
- Investigators
- Eric L. Granholm, PhD, Principal investigator, VA San Diego Healthcare System/University of California San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338975
- Sponsor's protocol ID
- R01MH071410
- Other IDs
- R01MH071410, DSIR 83-ATAP
- Status last verified
- Jun 2015
- First submitted
- 16 Jun 2006
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15741469Granholm 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.
PubMed 11728848McQuaid 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.
PubMed 10896740Brenner 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.
PubMed 1389037Granholm 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.
PubMed 17503982Granholm 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.
PubMed 24911420
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Skills Training for Schizophrenia
- ClinicalTrials.gov ID
- NCT00338975
- Acronym / sponsor ID
- R01MH071410
- Conditions
- Schizophrenia
- Keywords
- Psychotic Disorders, Schizoaffective Disorder, Cognitive Behavioral Therapy, Social Skills Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioral Social Skills Training (CBSST), Behavioral: Social Skills Training, Behavioral: Goal SettingCognitive Behavioral Social Skills Training (CBSST) |
| 2 | Active comparator | Behavioral: Goal-focused supportive contact (GFSC), Behavioral: Goal SettingGoal-Focused Supportive Contact (GFSC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder at any stage of illness
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Social Skills Training (CBSST)Also: CBT, SSTThere 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. | Behavioural | 1 |
| 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. | Behavioural | 2 |
| Social Skills TrainingAlso: SSTThe 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. | Behavioural | 1 |
| Goal SettingAll 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 . | Behavioural | 1, 2 |
Primary outcome
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)
3 secondary outcomes
Neuropsychological functioning
Time frame: Measured at baseline and Months 9 and 21
Cognitive insight
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background: PubMed 15741469Granholm 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.
- Background: PubMed 11728848Granholm 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.
- Background: PubMed 10896740McQuaid 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.
- Background: PubMed 1389037Brenner 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.
- Background: PubMed 17503982Granholm 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.
- Derived from this study: PubMed 24911420Granholm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric L. Granholm, PhD principal investigator
VA San Diego Healthcare System/University of California San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Social Skills Training (CBSST), Goal-focused supportive contact (GFSC) and Social Skills Training in people with Schizophrenia, run by Veterans Medical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning (time frame: Measured at baseline and Months 9 and 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00338975, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.