Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
Study NCT ID:
NCT04321759
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2020-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CER-2018C3-14701 | OTHER_GRANT | PCORI | View |