Clinical trial NCT06251193: Optimizing CBSST with Executive Function Training for Schizophrenia
Official title: Optimizing Cognitive Behavioral Social Skills Training with Executive Function Training for Older Adults with Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2024-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study to test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). The aims include determining whether E-CBSST is feasible and increases Cognitive Behavioral Social Skills Training (CBSST) Skills Learning to a level that will lead to a clinically meaningful improvement in functioning.

Detailed description: Older adults with schizophrenia are at risk for cognitive and functional decline leading to premature institutionalization. A large and increasing number of older people with schizophrenia will need more effective services. The investigators previously developed Cognitive Behavioral Social Skills Training (CBSST) and established its efficacy for preventing functional decline in people with schizophrenia. CBSST combines Cognitive Behavioral Therapy (CBT), Social Skills Training (SST), and problem-solving intervention modules in an 18-session intervention that is repeated to practice the skills for a total of 36 sessions. The findings suggested that CBSST Skills Learning is an important mechanism of change in functioning in CBSST and that boosting executive function could boost CBSST Skills Learning, which could improve rather than only stabilize functioning. The investigators intend to test a blended intervention that combines CBSST and Executive Functioning Training (E-CBSST). In this open trial, 50 participants with schizophrenia or schizoaffective disorder age 60 or older will be enrolled to receive E-CBSST for 20 weeks. E-CBSST will consist first of a 2-week Executive Function Training (EFT) course that includes 3 sessions per week of computerized exercises and strategy monitoring using a worksheet and assistance from a therapist. Participants will then complete 2 cycles of E-CBSST with 18 sessions each cycle, delivered twice a week, during which participants receive brief EFT at the start of CBSST group sessions. Outcome assessments will be administered at baseline, end of Executive Function Training course (Week 2), after session 18 (mid-trial; end of first cycle) and session 36 (end-trial; end of second cycle).

The aims of the study include determining if E-CBSST is feasible and increases CBSST Skills Learning to a level that will lead to a clinically meaningful improvement in functioning and to identify the minimum number of weeks of the intervention needed to produce this change. E-CBSST could become an evidence-based intervention that enhances and not only maintains function and, in turn, reduces personal and societal burden.

Eligibility criteria: Inclusion Criteria:

1. Voluntary informed consent to participate;
2. Age 60 years or older;
3. DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on the SCID;
4. Be clinically stable as operationalized by (1) not having been admitted to a psychiatric hospital within the three months prior to assessment, (2) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (3) and ascertained to be clinically and medically stable by one the study investigators;
5. Be willing and able to speak English;
6. Be able to read and converse (with corrected vision or hearing if needed).

Exclusion Criteria:

1. Meets criteria for a cognitive disorder or for a neurological or other medical disorder affecting the ability to participate in Executive Function Training or CBSST;
2. Meets diagnostic criteria for bipolar disorder, current major depressive episode, or substance abuse or dependence within the six months prior to the baseline assessment except for caffeine or nicotine;
3. Received electroconvulsive therapy within six months of the baseline assessment.

Primary outcomes:
measure: Independent Living Skills Survey
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Comprehensive Modules Test
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Secondary outcomes:
measure: Social Skills Performance Assessment
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Brief Assessment of Cognition in Schizophrenia
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Delis-Kaplan Executive Function System
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Executive Interview
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Positive and Negative Syndrome Scale
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Geriatric Depression Scale
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Cumulative Illness Rating Scale-Geriatric
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Defeatest Performance Attitudes Scale
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Clinical Assessment Interview for Negative Symptoms
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
measure: Birchwood Social Functioning Scale
timeFrame: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: University of California, San Diego
name: Eric Granholm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Tarek Rajji, MD
role: PRINCIPAL_INVESTIGATOR
References: