Schizophrenia and Related DisordersNCT04321759
Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)
A study testing Cognitive Enhancement Therapy and Social Skills Training in people with Schizophrenia and Related Disorders, run by Beth Israel Deaconess Medical Center at 5 sites in United States.
Trial summary
To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia and Related Disorders
- What is being tested?
- Cognitive Enhancement Therapy 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
- 378 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2021to 31 Jan 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 to 65;
- DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview);
- estimated IQ of > 70 (established via WTAR).
Who cannot join
- the presence of a current organic brain syndrome;
- intellectual disability (DSM-5);
- participation in either CET or SST within the prior year.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
Massachusetts Mental Health Center
Boston, Massachusetts, 02115
Fred Crow, MD
- Active, not recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Hartford Hospital - Institute of Living
Hartford, Connecticut, 06106
Jimmy Choi, PsyD
- Recruiting
Maine Medical Center
Portland, Maine, 04102
Kristen Woodberry, MSW, PhD
- Recruiting
UMass Medical School
Worcester, Massachusetts, 01603
Xaioduo Fan, MD, MPH
About this study
Official title: Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness
To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.
Read the detailed description
Aim 1. We will test our hypothesis that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (NIH Toolbox, PennCNB, and MSCEIT) and social skills (SSPA). For study Aim 1, we hypothesized that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (selected NIH Toolbox and Penn CNB measures, and MSCEIT) and social skills (SSPA). Aim 2: We will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, we hypothesize that patients with less impairment in cognitive functioning at baseline will demonstrate relatively larger treatment gains in SST compared to those in CET than those who are initially more cognitively impaired, and that younger patients will benefit more from CET compared to those in SST than those who are older. The results of this study will address a key knowledge gap in the field and a decisional dilemma for clinicians. A pilot study at four treatment sites will be used to test the feasibility and acceptability of telementalhealth delivery of these two treatments, as compared to in-person delivery.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- Cognitive Enhancement Therapy, Social Skills Training
- Keywords
- Cognitive functioning, Social skills, Community functioning
- Medical subject headings
- Schizophrenia, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Enhancement TherapyBehavioural
CET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both.
Social Skills TrainingBehavioural
Also called HOPES
The psychosocial component involves weekly skills training classes delivered over one year, with modules including "Communicating Effectively," "Making and Keeping Friends," "Making the Most of Leisure Time," "Healthy Living," "Using Medications Effectively," and "Making the Most of a Health Care Visit" (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Enhancement Therapy | Experimental | CET is a comprehensive manualized cognitive remediation program designed to maximize gains in social functioning by integrating computer-based training to enhance neurocognition with group-based exercises to improve social cognition. Receives: Behavioral: Cognitive Enhancement Therapy |
| Social Skills Training | Active comparator | The HOPES social rehabilitation program uses the principles of SST (modeling, role playing, positive and corrective feedback, homework assignments, in vivo skills practice), designed to improve both psychosocial functioning and preventive health.. Receives: Behavioral: Social Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Adjustment Scale II
Measure of social functioning
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Heinrich Quality of Life Scale
Measure of social functioning
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Social Skills Performance Assessment
Measure of social functioning using role played scenarios
Measured: Measurement at 0, 6, 12, 18, 24 months
Secondary outcomes (11)
Change in Auditory Verbal Learning Test
Neurocognition measure of verbal ability in NIH Toolbox
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in List Sorting Working Memory
Neurocognition measure of working memory in NIH Toolbox
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Positive and Negative Syndrome Scale, PANSS-6
Short form of measure of positive and negative symptoms
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Picture Sequence Memory
Neurocognition measure of visual/episodic memory \& learning in NIH Toolbox
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Picture Vocabulary
Neurocognition measure of language in NIH Toolbox
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Oral Reading Recognition
Neurocognition measure of language in NIH Toolbox
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Mouse Practice Test
Neurocognition measure of speed of processing in PennCNB
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Digit Symbol Test
Neurocognition measure of speed of processing in PennCNB
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Conditional Exclusion Test
Neurocognition measure of reasoning \& problem solving in PennCNB
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Continuous Performance Test
Neurocognition measure of reasoning \& problem solving in PennCNB
Measured: Measurement at 0, 6, 12, 18, 24 months
Change in Managing Emotions
Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Measured: Measurement at 0, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Jun 2021
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Model description
- Randomized cluster design with 19 service centers assigned to one of the two treatments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Matcheri S. Keshavan MD, Beth Israel Deaconess Medical Center
- Investigators
- Matcheri S Keshavan, MD, Principal investigator, Beth Israel Deaconess Medical CenterRussell K Schutt, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321759
- Sponsor's protocol ID
- 2020P000094
- Other IDs
- CER-2018C3-14701
- Status last verified
- Nov 2023
- First submitted
- 18 Mar 2020
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schutt RK, Xie H, Mueser KT, Killam MA, Delman J, Eack SM, Mesholam-Gately R, Pratt SI, Sandoval L, Santos MM, Golden LR, Keshavan MS. Cognitive Enhancement Therapy vs social skills training in schizophrenia: a cluster randomized comparative effectiveness evaluation. BMC Psychiatry. 2022 Sep 1;22(1):583. doi: 10.1186/s12888-022-04149-x.
PubMed 36050663
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness
- ClinicalTrials.gov ID
- NCT04321759
- Acronym / sponsor ID
- 2020P000094
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- Cognitive functioning, Social skills, Community functioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 25 Mar 2020 (actual)
- 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.
To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.
Detailed description
Aim 1. We will test our hypothesis that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (NIH Toolbox, PennCNB, and MSCEIT) and social skills (SSPA). For study Aim 1, we hypothesized that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (selected NIH Toolbox and Penn CNB measures, and MSCEIT) and social skills (SSPA). Aim 2: We will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, we hypothesize that patients with less impairment in cognitive functioning at baseline will demonstrate relatively larger treatment gains in SST compared to those in CET than those who are initially more cognitively impaired, and that younger patients will benefit more from CET compared to those in SST than those who are older. The results of this study will address a key knowledge gap in the field and a decisional dilemma for clinicians. A pilot study at four treatment sites will be used to test the feasibility and acceptability of telementalhealth delivery of these two treatments, as compared to in-person delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized cluster design with 19 service centers assigned to one of the two treatments.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Enhancement Therapy | Experimental | Behavioral: Cognitive Enhancement TherapyCET is a comprehensive manualized cognitive remediation program designed to maximize gains in social functioning by integrating computer-based training to enhance neurocognition with group-based exercises to improve social cognition. |
| Social Skills Training | Active comparator | Behavioral: Social Skills TrainingThe HOPES social rehabilitation program uses the principles of SST (modeling, role playing, positive and corrective feedback, homework assignments, in vivo skills practice), designed to improve both psychosocial functioning and preventive health.. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 to 65;
- DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview);
- estimated IQ of > 70 (established via WTAR).
Key exclusion criteria (3 listed)
- the presence of a current organic brain syndrome;
- intellectual disability (DSM-5);
- participation in either CET or SST within the prior year.
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 Enhancement TherapyCET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both. | Behavioural | Cognitive Enhancement Therapy |
| Social Skills TrainingAlso: HOPESThe psychosocial component involves weekly skills training classes delivered over one year, with modules including "Communicating Effectively," "Making and Keeping Friends," "Making the Most of Leisure Time," "Healthy Living," "Using Medications Effectively," and "Making the Most of a Health Care Visit" (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises. | Behavioural | Social Skills Training |
Primary outcome
Change in Social Adjustment Scale II
Time frame: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning
Change in Heinrich Quality of Life Scale
Time frame: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning
Change in Social Skills Performance Assessment
Time frame: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning using role played scenarios
11 secondary outcomes
Change in Auditory Verbal Learning Test
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in List Sorting Working Memory
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Positive and Negative Syndrome Scale, PANSS-6
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Picture Sequence Memory
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Picture Vocabulary
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Oral Reading Recognition
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Mouse Practice Test
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Digit Symbol Test
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Conditional Exclusion Test
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Continuous Performance Test
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Managing Emotions
Time frame: Measurement at 0, 6, 12, 18, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Results publication: PubMed 36050663Schutt RK, Xie H, Mueser KT, Killam MA, Delman J, Eack SM, Mesholam-Gately R, Pratt SI, Sandoval L, Santos MM, Golden LR, Keshavan MS. Cognitive Enhancement Therapy vs social skills training in schizophrenia: a cluster randomized comparative effectiveness evaluation. BMC Psychiatry. 2022 Sep 1;22(1):583. doi: 10.1186/s12888-022-04149-x.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia and Related Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
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.
Matcheri S Keshavan, MD principal investigator
Beth Israel Deaconess Medical Center
Russell K Schutt, PhD principal investigator
Beth Israel Deaconess Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Enhancement Therapy and Social Skills Training in people with Schizophrenia and Related Disorders, run by Beth Israel Deaconess Medical Center at 5 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Sabbagh (617-975-8545 ext. 58545, jsabbagh@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Adjustment Scale II (time frame: Measurement at 0, 6, 12, 18, 24 months). The study lists 3 primary outcomes in all. 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 NCT04321759, 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 14 Nov 2023.