SchizophreniaCBSSTNCT00832845
Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study
A study testing CBSST plus treatment as usual and Treatment as usual (TAU) in people with Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Schizophrenia is associated with significant cognitive and functional deficits. As patients with schizophrenia grow older, the impact of these deficits at a personal and public health level is likely to increase. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CBSST plus treatment as usual and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to May 2014
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years and above.
- All races and ethnicities.
- Females and males.
- Meets DSM-IV TR criteria for a current diagnosis of schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or psychotic disorder NOS.
- Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in antipsychotic medication dosage within the 4 weeks prior to assessment, and (3) and ascertained to be clinically stable by one the study psychiatrists.
- Willingness and ability to speak English
- Willingness to provide informed consent
- Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.
Who cannot join
- Meets criteria for a cognitive disorder secondary to a neurological or other medical disorder affecting the ability to participate in CBSST.
- Diagnosis of bipolar disorder or current major depressive episode.
- Meets diagnostic criteria for substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine.
- Electroconvulsive Therapy (ECT) within 6 months of initial assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Schizophrenia is associated with significant cognitive and functional deficits. As patients with schizophrenia grow older, the impact of these deficits at a personal and public health level is likely to increase. Cognitive Behavioral and Social Skills Training (CBSST) is a recently developed group therapy that increased the frequency of social activities among middle-aged patients with schizophrenia. It also increased cognitive insight, a measure of the ability to reduce confidence in aberrant beliefs. To date, CBSST has not been studied in late-life schizophrenia. In addition, its impact on medications management, an instrumental function that is particularly salient in late life, and its interactions with cognition are largely unknown. Thus, we propose to study the efficacy of CBSST in improving social skills and medications management in patients with late-life schizophrenia, and to study the interactions between the patients' cognitive characteristics and their response to CBSST.
Previous studies show that cognitive deficits are strong predictors of response to CBSST. Cognitive Remediation Treatments (CRTs) have been shown to improve cognition in patients with schizophrenia especially when combined with psychosocial interventions that focus on function such as CBSST. Thus, we also propose to assess the tolerability and impact of CRT on patients with late-life schizophrenia.
Read the detailed description
Eighty subjects will be randomized into 2 arms, CBSST Group and Treatment as Usual Group. Both Arms will run for a total of 52 weeks. The CBSST Group will attend 2-hour weekly sessions for 9 months and attend follow up assessments every 4 months. The Treatment as Usual Group will continue with their normal psychiatric treatment as usual and also attend follow up assessments every 4 months. After subjects in the Treatment as Usual Arm finish, they will continue on to the CBSST Group arm.
After the completion of the CBSST Group Arm, 24 subjects who are willing to consent to CRT will continue with an additional 2-hour weekly session of Cognitive Remediation Treatment for 8 weeks.
- Conditions
- Schizophrenia
- Being tested
- CBSST plus treatment as usual, Treatment as usual (TAU)
- Keywords
- Late-life schizophrenia (LLS), Cognitive Behavioural Social Skills Training (CBSST), Randomized
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBSST plus treatment as usualBehavioural
Patients will receive CBSST in addition to their regular treatment for 36 weeks.
Treatment as usual (TAU)Behavioural
Patients will receive their regular treatment for 36 weeks without CBSST. TAU consists of the standard care that patients receive, including routine visits and contacts with their physicians and clinicians.
| Study group | Role | What they receive |
|---|---|---|
| CBSST plus treatment as usual | Experimental | Subject randomized to the CBSST Group arm will attend 2 hour weekly Cognitive Behavioural Social Skills therapy sessions for 9 months. They will also be attending follow-up assessments q 4 months. Receives: Behavioral: CBSST plus treatment as usual |
| Treatment as Usual Group | Active comparator | Subjects randomized to the Treatment as Usual Group Arm will continue with their regular psychiatric treatment for 1 year. Like the CBSST Group Arm, they will have follow up assessments q 4 months. After completing the Treatment as Usual Group arm, they will automatically continue on with the CBSST Group Arm. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CBSST in improving social function
Measured: At termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Rajji, Centre for Addiction and Mental Health
- Investigators
- David C. Mamo, MD, MSc, Principal investigator, Centre for Addiction and Mental HealthTarek Rajji, MD, FRCPC, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832845
- Sponsor's protocol ID
- 066/2008
- Acronym
- CBSST
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2009
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rajji TK, Mamo DC, Holden J, Granholm E, Mulsant BH. Cognitive-Behavioral Social Skills Training for patients with late-life schizophrenia and the moderating effect of executive dysfunction. Schizophr Res. 2022 Jan;239:160-167. doi: 10.1016/j.schres.2021.11.051. Epub 2021 Dec 9.
PubMed 34896870Gerretsen P, Voineskos AN, Graff-Guerrero A, Menon M, Pollock BG, Mamo DC, Mulsant BH, Rajji TK. Insight Into Illness and Cognition in Schizophrenia in Earlier and Later Life. J Clin Psychiatry. 2017 Apr;78(4):e390-e397. doi: 10.4088/JCP.16m10741.
PubMed 28297590
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study
- ClinicalTrials.gov ID
- NCT00832845
- Acronym / sponsor ID
- CBSST / 066/2008
- Conditions
- Schizophrenia
- Keywords
- Late-life schizophrenia (LLS), Cognitive Behavioural Social Skills Training (CBSST), Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Jan 2009 (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.
Schizophrenia is associated with significant cognitive and functional deficits. As patients with schizophrenia grow older, the impact of these deficits at a personal and public health level is likely to increase. Cognitive Behavioral and Social Skills Training (CBSST) is a recently developed group therapy that increased the frequency of social activities among middle-aged patients with schizophrenia. It also increased cognitive insight, a measure of the ability to reduce confidence in aberrant beliefs. To date, CBSST has not been studied in late-life schizophrenia. In addition, its impact on medications management, an instrumental function that is particularly salient in late life, and its interactions with cognition are largely unknown. Thus, we propose to study the efficacy of CBSST in improving social skills and medications management in patients with late-life schizophrenia, and to study the interactions between the patients' cognitive characteristics and their response to CBSST.
Previous studies show that cognitive deficits are strong predictors of response to CBSST. Cognitive Remediation Treatments (CRTs) have been shown to improve cognition in patients with schizophrenia especially when combined with psychosocial interventions that focus on function such as CBSST. Thus, we also propose to assess the tolerability and impact of CRT on patients with late-life schizophrenia.
Detailed description
Eighty subjects will be randomized into 2 arms, CBSST Group and Treatment as Usual Group. Both Arms will run for a total of 52 weeks. The CBSST Group will attend 2-hour weekly sessions for 9 months and attend follow up assessments every 4 months. The Treatment as Usual Group will continue with their normal psychiatric treatment as usual and also attend follow up assessments every 4 months. After subjects in the Treatment as Usual Arm finish, they will continue on to the CBSST Group arm.
After the completion of the CBSST Group Arm, 24 subjects who are willing to consent to CRT will continue with an additional 2-hour weekly session of Cognitive Remediation Treatment for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBSST plus treatment as usual | Experimental | Behavioral: CBSST plus treatment as usualSubject randomized to the CBSST Group arm will attend 2 hour weekly Cognitive Behavioural Social Skills therapy sessions for 9 months. They will also be attending follow-up assessments q 4 months. |
| Treatment as Usual Group | Active comparator | Behavioral: Treatment as usual (TAU)Subjects randomized to the Treatment as Usual Group Arm will continue with their regular psychiatric treatment for 1 year. Like the CBSST Group Arm, they will have follow up assessments q 4 months. After completing the Treatment as Usual Group arm, they will automatically continue on with the CBSST Group Arm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 60 years and above.
- All races and ethnicities.
- Females and males.
- Meets DSM-IV TR criteria for a current diagnosis of schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or psychotic disorder NOS.
- Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in antipsychotic medication dosage within the 4 weeks prior to assessment, and (3) and ascertained to be clinically stable by one the study psychiatrists.
Key exclusion criteria (4 listed)
- Meets criteria for a cognitive disorder secondary to a neurological or other medical disorder affecting the ability to participate in CBSST.
- Diagnosis of bipolar disorder or current major depressive episode.
- Meets diagnostic criteria for substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine.
- Electroconvulsive Therapy (ECT) within 6 months of initial assessment.
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 |
|---|---|---|
| CBSST plus treatment as usualPatients will receive CBSST in addition to their regular treatment for 36 weeks. | Behavioural | CBSST plus treatment as usual |
| Treatment as usual (TAU)Patients will receive their regular treatment for 36 weeks without CBSST. TAU consists of the standard care that patients receive, including routine visits and contacts with their physicians and clinicians. | Behavioural | Treatment as Usual Group |
Primary outcome
Efficacy of CBSST in improving social function
Time frame: At termination
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 17 Feb 2021.
- Derived from this study: PubMed 34896870Rajji TK, Mamo DC, Holden J, Granholm E, Mulsant BH. Cognitive-Behavioral Social Skills Training for patients with late-life schizophrenia and the moderating effect of executive dysfunction. Schizophr Res. 2022 Jan;239:160-167. doi: 10.1016/j.schres.2021.11.051. Epub 2021 Dec 9.
- Derived from this study: PubMed 28297590Gerretsen P, Voineskos AN, Graff-Guerrero A, Menon M, Pollock BG, Mamo DC, Mulsant BH, Rajji TK. Insight Into Illness and Cognition in Schizophrenia in Earlier and Later Life. J Clin Psychiatry. 2017 Apr;78(4):e390-e397. doi: 10.4088/JCP.16m10741.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David C. Mamo, MD, MSc principal investigator
Centre for Addiction and Mental Health
Tarek Rajji, MD, FRCPC principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBSST plus treatment as usual and Treatment as usual (TAU) in people with Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 8 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 17 Feb 2021. 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 Canada. 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?
Efficacy of CBSST in improving social function (time frame: At termination). 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 NCT00832845, which also lists 2 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 17 Feb 2021.