SchizophreniaINSPIRENCT02170051
Improving Negative Symptoms of Psychosis In Real-world Environments
A study testing CBSST-CCT and Goal focused supportive contact in people with Schizophrenia, run by University of California, San Diego at 1 site in United States.
Trial summary
This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CBSST-CCT and Goal focused supportive contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2014to 3 Sep 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE.
- Voluntary informed consent to participate
- Age 18 to 65
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID
- Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score >19)
- ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual)
- Stable on medications; no changes within 3 months prior to enrollment
Who cannot join
- Prior CBT, SST, or CCT in the past 5 years
- Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness >5)
- Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS >8)
- Ocular damage/disease/surgery/medications that affect pupil dilation
- DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID
- Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness) .
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- CBSST-CCT, Goal focused supportive contact
- Keywords
- negative symptoms, cognition, functioning, defeatist attitudes, psychosocial treatment
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBSST-CCTBehavioural
Also called Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
Goal focused supportive contactBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CBSST-CCT | Experimental | Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training Receives: Behavioral: CBSST-CCT |
| Goal-focused supportive contact | Active comparator | Goal-focused supportive contact Receives: Behavioral: Goal focused supportive contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment Interview for Negative Symptoms (CAINS)
Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.
Measured: baseline, 12.5 weeks
Secondary outcomes (7)
MATRICS Consensus Cognitive Battery (MCCB)
Change in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance.
Measured: baseline, 12.5 weeks
UCSD Performance-based Skills Assessment-Brief (UPSA-B)
Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance.
Measured: baseline, 12.5 weeks
Social Skills Performance Assessment (SSPA)
Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills.
Measured: baseline, 12.5 weeks
Specific Levels of Functioning Scale (SLOF)
Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning.
Measured: baseline, 12.5 weeks
Independent Living Skills Survey (ILSS)
Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills.
Measured: baseline, 12.5 weeks
Defeatist Performance Attitudes Scale (DPAS)
Change in defeatist attitudes at 12.5 weeks. Likert Scale 1-7; scores range from 15-105; higher scores indicate a more severe defeatist performance attitude.
Measured: baseline, 12.5 weeks
Scale for the Assessment of Negative Symptoms (SANS)
Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity.
Measured: baseline, 12.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start1 Jul 2014
- Primary completion3 Sep 2018
- Study completion3 Sep 2018
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 SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Elizabeth Twamley, University of California, San Diego
- Investigators
- Elizabeth Twamley, PhD, Principal investigator, UCSDEric Granholm, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170051
- Sponsor's protocol ID
- 130424
- Other IDs
- 1R34MH101250
- Acronym
- INSPIRE
- Status last verified
- Apr 2021
- First submitted
- 18 Jun 2014
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Granholm E, Twamley EW, Mahmood Z, Keller AV, Lykins HC, Parrish EM, Thomas ML, Perivoliotis D, Holden JL. Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. Schizophr Bull. 2022 Mar 1;48(2):359-370. doi: 10.1093/schbul/sbab126.
PubMed 34665853
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Negative Symptoms of Psychosis In Real-world Environments
- ClinicalTrials.gov ID
- NCT02170051
- Acronym / sponsor ID
- INSPIRE / 130424
- Conditions
- Schizophrenia
- Keywords
- negative symptoms, cognition, functioning, defeatist attitudes, psychosocial treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBSST-CCT | Experimental | Behavioral: CBSST-CCTCognitive Behavioral Social Skills Training-Compensatory Cognitive Training |
| Goal-focused supportive contact | Active comparator | Behavioral: Goal focused supportive contactGoal-focused supportive contact |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE.
- Voluntary informed consent to participate
- Age 18 to 65
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID
- Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score >19)
Key exclusion criteria (6 listed)
- Prior CBT, SST, or CCT in the past 5 years
- Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness >5)
- Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS >8)
- Ocular damage/disease/surgery/medications that affect pupil dilation
- DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID
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-CCTAlso: Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training | Behavioural | CBSST-CCT |
| Goal focused supportive contact | Behavioural | Goal-focused supportive contact |
Primary outcome
Clinical Assessment Interview for Negative Symptoms (CAINS)
Time frame: baseline, 12.5 weeks
Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.
7 secondary outcomes
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: baseline, 12.5 weeks
UCSD Performance-based Skills Assessment-Brief (UPSA-B)
Time frame: baseline, 12.5 weeks
Social Skills Performance Assessment (SSPA)
Time frame: baseline, 12.5 weeks
Specific Levels of Functioning Scale (SLOF)
Time frame: baseline, 12.5 weeks
Independent Living Skills Survey (ILSS)
Time frame: baseline, 12.5 weeks
Defeatist Performance Attitudes Scale (DPAS)
Time frame: baseline, 12.5 weeks
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: baseline, 12.5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34665853Granholm E, Twamley EW, Mahmood Z, Keller AV, Lykins HC, Parrish EM, Thomas ML, Perivoliotis D, Holden JL. Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. Schizophr Bull. 2022 Mar 1;48(2):359-370. doi: 10.1093/schbul/sbab126.
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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.
Elizabeth Twamley, PhD principal investigator
UCSD
Eric Granholm, PhD principal investigator
UCSD
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-CCT and Goal focused supportive contact in people with Schizophrenia, run by University of California, San Diego 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 7 inclusion and 6 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 19 May 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 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 27 Nov 2020). 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?
Clinical Assessment Interview for Negative Symptoms (CAINS) (time frame: baseline, 12.5 weeks). 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 NCT02170051, 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 19 May 2021.