Clinical trial NCT04321759: Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)
Official title: Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia and Related Disorders
Keywords: Cognitive functioning
Social skills
Community functioning
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-03-25
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized cluster design with 19 service centers assigned to one of the two treatments.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Social Adjustment Scale II
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Heinrich Quality of Life Scale
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Social Skills Performance Assessment
timeFrame: Measurement at 0, 6, 12, 18, 24 months
Secondary outcomes:
measure: Change in Auditory Verbal Learning Test
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in List Sorting Working Memory
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Positive and Negative Syndrome Scale, PANSS-6
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Picture Sequence Memory
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Picture Vocabulary
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Oral Reading Recognition
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Penn Mouse Practice Test
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Penn Digit Symbol Test
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Penn Conditional Exclusion Test
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Penn Continuous Performance Test
timeFrame: Measurement at 0, 6, 12, 18, 24 months
measure: Change in Managing Emotions
timeFrame: Measurement at 0, 6, 12, 18, 24 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital - Institute of Living
state: Connecticut
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Massachusetts Mental Health Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Matcheri S Keshavan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Russell K Schutt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.