Schizophrenia and Related Disorders
Conditions
Keywords
Cognitive functioning, Social skills, Community functioning
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.
Interventions
BEHAVIORALCognitive Enhancement Therapy
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.
BEHAVIORALSocial Skills Training
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.
Sponsors
Patient-Centered Outcomes Research Institute
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized cluster design with 19 service centers assigned to one of the two treatments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. age 18 to 65; 2. DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview); 3. estimated IQ of \> 70 (established via WTAR).
Exclusion criteria
1. the presence of a current organic brain syndrome; 2. intellectual disability (DSM-5); 3. participation in either CET or SST within the prior year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Adjustment Scale II | Measurement at 0, 6, 12, 18, 24 months | Measure of social functioning |
| Change in Heinrich Quality of Life Scale | Measurement at 0, 6, 12, 18, 24 months | Measure of social functioning |
| Change in Social Skills Performance Assessment | Measurement at 0, 6, 12, 18, 24 months | Measure of social functioning using role played scenarios |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Picture Sequence Memory | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of visual/episodic memory & learning in NIH Toolbox |
| Change in Picture Vocabulary | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of language in NIH Toolbox |
| Change in Oral Reading Recognition | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of language in NIH Toolbox |
| Change in Penn Mouse Practice Test | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of speed of processing in PennCNB |
| Change in Auditory Verbal Learning Test | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of verbal ability in NIH Toolbox |
| Change in Penn Conditional Exclusion Test | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of reasoning & problem solving in PennCNB |
| Change in Penn Continuous Performance Test | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of reasoning & problem solving in PennCNB |
| Change in Managing Emotions | Measurement at 0, 6, 12, 18, 24 months | Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) |
| Change in Penn Digit Symbol Test | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of speed of processing in PennCNB |
| Change in List Sorting Working Memory | Measurement at 0, 6, 12, 18, 24 months | Neurocognition measure of working memory in NIH Toolbox |
| Change in Positive and Negative Syndrome Scale, PANSS-6 | Measurement at 0, 6, 12, 18, 24 months | Short form of measure of positive and negative symptoms |
Countries
United States
Contacts
Primary ContactJennifer Sabbagh
Backup ContactBlanche Spindell
Outcome results
None listed