Psychotic DisordersNCT00237796
Functional Rehabilitation of Older Patients With Schizophrenia
A study testing Cognitive Behavioral Social Skills Training (CBSST) and Goal Focused Supportive Contact (GFSC) in people with Psychotic Disorders and Schizoaffective Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The primary purpose of this project is to evaluate the efficacy of a group therapy intervention, cognitive behavioral social skills training (CBSST), that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Psychotic Disorders, Schizoaffective Disorder, Schizophrenia
- What is being tested?
- Cognitive Behavioral Social Skills Training (CBSST) and Goal Focused Supportive Contact (GFSC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years of age and older
- DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder
- Fluent in speaking, reading, and writing English
- Physically and psychiatrically stable enough to undergo various assessments in this study
Who cannot join
- Has not received Cognitive Behavioral Therapy (CBT) or Social Skills Training (SST) or Dialectical Behavioral Therapy (DBT) in the past 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
About this study
The primary purpose of this project is to evaluate the efficacy of a group therapy intervention, cognitive behavioral social skills training (CBSST), that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to disability in aging veterans with severe mental illness.
Read the detailed description
This is a randomized-controlled clinical trial comparing 2 treatment conditions: Goal focused supportive care (SC); and CBSST. Subjects (N=100) will be recruited, treated for 9 months and followed longitudinally for 9 months after treatment. A multidimensional evaluation of treatment outcome, including social functioning (primary outcome), neuropsychological functioning, cognitive insight, psychotic symptoms, and health services utilization, will be conducted at baseline, end of treatment (9-month follow-up), and 9 months post-treatment. 100 patients with schizophrenia or schizoaffective disorder will participate on a voluntary basis and will be paid $50.00 per assessment visit. Subjects will not be paid or given any incentive for treatment. The following inclusion/exclusion criteria will be used: (i) Voluntary informed consent for participation (given by the patient or conservator); (ii) Age 45 or older; (iii) DSM-IV-diagnosis (APA, 1994) of schizophrenia or schizoaffective disorder at any stage of illness; (iv) No prior exposure to SST or CBT in the past 5 years; (v) Level of care required at baseline does not interfere with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric, or physical illness). We anticipate that we will be able to provide an empirically validated intervention that can be used by clinicians on multidisciplinary rehabilitation teams to reduce disability in aging patients with schizophrenia. The products from this research will be written research reports and a therapy manual and patient workbook to guide rehabilitation that can be disseminated (e.g., via the internet) to relevant clinicians.
- Conditions
- Psychotic Disorders, Schizoaffective Disorder, Schizophrenia
- Being tested
- Cognitive Behavioral Social Skills Training (CBSST), Goal Focused Supportive Contact (GFSC)
- Keywords
- Behavioral, Cognitive, Functioning, Older, CBT, Rehabilitation, Schizophrenia, Skills, Social, Training
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Behavior
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
Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
Goal Focused Supportive Contact (GFSC)Behavioural
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | Cognitive Behavioral Social Skills Training (CBSST) Receives: Behavioral: Cognitive Behavioral Social Skills Training (CBSST) |
| ARM 2 | Active comparator | Goal Focused Supportive Contact (GFSC) Receives: Behavioral: Goal Focused Supportive Contact (GFSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent Living Skills Survey (ILSS)
The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.
Measured: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
Secondary outcomes (6)
Comprehensive Module Test (CMT)
The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.
Measured: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility. Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms.
Measured: baseline, mid-treatment, end of treatment, mid follow-up, and followup
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13).
Measured: baseline, mid treatment, end of treatment, mid follow-up, and follow up
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22).
Measured: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Beck Depression Inventory-II (BDI-II)
The BDI-II is a self-report measure of depression that consists of 21 questions. The total scale ranges from 0-63. Scores from individual questions are summed to yield a total score. Higher scores represent greater severity of depression.
Measured: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions. Scores from individual items are summed to yield a total score. The total score ranges from 0-63. Higher scores represent greater severity of anxiety.
Measured: baseline, mid-treatment, end of treatment, mid follow-up, and follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startFeb 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric L. Granholm, PhD, Principal investigator, VA San Diego Healthcare System, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237796
- Sponsor's protocol ID
- O3341-R
- Status last verified
- Mar 2015
- First submitted
- 7 Oct 2005
- Last updated
- 6 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Granholm E, Holden J, Link PC, McQuaid JR, Jeste DV. Randomized controlled trial of cognitive behavioral social skills training for older consumers with schizophrenia: defeatist performance attitudes and functional outcome. Am J Geriatr Psychiatry. 2013 Mar;21(3):251-62. doi: 10.1016/j.jagp.2012.10.014. Epub 2013 Jan 10.
PubMed 23395192
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Rehabilitation of Older Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00237796
- Acronym / sponsor ID
- O3341-R
- Conditions
- Psychotic Disorders, Schizoaffective Disorder, Schizophrenia
- Keywords
- Behavioral, Cognitive, Functioning, Older, CBT, Rehabilitation, Schizophrenia, Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this project is to evaluate the efficacy of a group therapy intervention, cognitive behavioral social skills training (CBSST), that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to disability in aging veterans with severe mental illness.
Detailed description
This is a randomized-controlled clinical trial comparing 2 treatment conditions: Goal focused supportive care (SC); and CBSST. Subjects (N=100) will be recruited, treated for 9 months and followed longitudinally for 9 months after treatment. A multidimensional evaluation of treatment outcome, including social functioning (primary outcome), neuropsychological functioning, cognitive insight, psychotic symptoms, and health services utilization, will be conducted at baseline, end of treatment (9-month follow-up), and 9 months post-treatment. 100 patients with schizophrenia or schizoaffective disorder will participate on a voluntary basis and will be paid $50.00 per assessment visit. Subjects will not be paid or given any incentive for treatment. The following inclusion/exclusion criteria will be used: (i) Voluntary informed consent for participation (given by the patient or conservator); (ii) Age 45 or older; (iii) DSM-IV-diagnosis (APA, 1994) of schizophrenia or schizoaffective disorder at any stage of illness; (iv) No prior exposure to SST or CBT in the past 5 years; (v) Level of care required at baseline does not interfere with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric, or physical illness). We anticipate that we will be able to provide an empirically validated intervention that can be used by clinicians on multidisciplinary rehabilitation teams to reduce disability in aging patients with schizophrenia. The products from this research will be written research reports and a therapy manual and patient workbook to guide rehabilitation that can be disseminated (e.g., via the internet) to relevant clinicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Behavioral: Cognitive Behavioral Social Skills Training (CBSST)Cognitive Behavioral Social Skills Training (CBSST) |
| ARM 2 | Active comparator | Behavioral: Goal Focused Supportive Contact (GFSC)Goal Focused Supportive Contact (GFSC) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45 years of age and older
- DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder
- Fluent in speaking, reading, and writing English
- Physically and psychiatrically stable enough to undergo various assessments in this study
Key exclusion criteria (1 listed)
- Has not received Cognitive Behavioral Therapy (CBT) or Social Skills Training (SST) or Dialectical Behavioral Therapy (DBT) in the past 5 years
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)Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months. | Behavioural | ARM 1 |
| Goal Focused Supportive Contact (GFSC)Active goal setting and supportive contact in group therapy 2 hours per week for 9 months. | Behavioural | ARM 2 |
Primary outcome
Independent Living Skills Survey (ILSS)
Time frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.
6 secondary outcomes
Comprehensive Module Test (CMT)
Time frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and followup
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
Time frame: baseline, mid treatment, end of treatment, mid follow-up, and follow up
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Beck Depression Inventory-II (BDI-II)
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Beck Anxiety Inventory (BAI)
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23395192Granholm E, Holden J, Link PC, McQuaid JR, Jeste DV. Randomized controlled trial of cognitive behavioral social skills training for older consumers with schizophrenia: defeatist performance attitudes and functional outcome. Am J Geriatr Psychiatry. 2013 Mar;21(3):251-62. doi: 10.1016/j.jagp.2012.10.014. Epub 2013 Jan 10.
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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, 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) and Goal Focused Supportive Contact (GFSC) in people with Psychotic Disorders and Schizoaffective Disorder, run by US Department of Veterans Affairs 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 4 inclusion and 1 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 6 Apr 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?
Yes. Results are posted in the registry (first posted 6 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Independent Living Skills Survey (ILSS) (time frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up). 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 NCT00237796, which also lists 1 linked publication.
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 6 Apr 2015.