Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 378
- Locations
- 5
- Primary Endpoint
- Change in Social Adjustment Scale II
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •the presence of a current organic brain syndrome;
- •intellectual disability (DSM-5);
- •participation in either CET or SST within the prior year.
Arms & Interventions
Cognitive Enhancement Therapy
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.
Intervention: Cognitive Enhancement Therapy (Behavioral)
Social Skills Training
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..
Intervention: Social Skills Training (Behavioral)
Outcomes
Primary Outcomes
Change in Social Adjustment Scale II
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
Change in Heinrich Quality of Life Scale
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning
Secondary Outcomes
- Change in Penn Mouse Practice Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in Picture Sequence Memory(Measurement at 0, 6, 12, 18, 24 months)
- Change in Auditory Verbal Learning Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in Picture Vocabulary(Measurement at 0, 6, 12, 18, 24 months)
- Change in Penn Digit Symbol Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in List Sorting Working Memory(Measurement at 0, 6, 12, 18, 24 months)
- Change in Positive and Negative Syndrome Scale, PANSS-6(Measurement at 0, 6, 12, 18, 24 months)
- Change in Oral Reading Recognition(Measurement at 0, 6, 12, 18, 24 months)
- Change in Penn Conditional Exclusion Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in Penn Continuous Performance Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in Managing Emotions(Measurement at 0, 6, 12, 18, 24 months)
Investigators
Matcheri S. Keshavan MD
Stanley Cobb Professor and Academic Head of Psychiatry, Department of Psychiatry,
Beth Israel Deaconess Medical Center