Other Primary Psychotic Disorders, Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
This research on cognitive training addresses the following questions: 1. Does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses? 2. What are the neurocognitive and non-cognitive factors that predict good outcomes following cognitive rehabilitation? In addition to verbal learning and memory, immediate verbal memory, vigilance, and executive functioning, the cognitive training intervention attempted to improve prospective memory ability (i.e., the ability to remember to do things in the future, such as take medications or attend a doctor's appointment).
Interventions
BEHAVIORALCognitive Training
12-week compensatory cognitive training in group format
Sponsors
National Alliance for Research on Schizophrenia and Depression
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Primary psychotic disorder (including schizophrenia, schizoaffective disorder, psychotic mood disorder, or psychosis NOS) * Age 18 or older * Fluency in English
Exclusion criteria
* Dementia * Neurological conditions affecting cognition * Mental retardation * Substance use disorder within the past month * Participation in other intervention trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity) | 3 months | Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hopkins Verbal Learning Test Percent Retained | 3 months | Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial. Score ranges from 0-100. Higher scores represent better performance. |
Countries
United States
Participant flow
Recruitment details
Participants included 89 community-dwelling outpatients. Inclusion criteria were: primary psychotic disorder, age 18 or older, and fluency in English. Exclusion criteria were: dementia, neurological conditions affecting cognition, mental retardation, substance use disorder within the past month, and participation in other intervention trials.
Pre-assignment details
Baseline data were collected before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Training Cognitive training group | 38 |
| Standard Pharmacotherapy standard pharmacotherapy with regular clinician | 31 |
| Total | 69 |
Baseline characteristics
| Characteristic | Standard Pharmacotherapy | Cognitive Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 37 Participants | 68 Participants |
| Age, Continuous | 48.8 years STANDARD_DEVIATION 8.7 | 44.3 years STANDARD_DEVIATION 10.1 | 46.3 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 31 participants | 38 participants | 69 participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 21 Participants | 24 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 31 |
| serious Total, serious adverse events | 0 / 38 | 0 / 31 |
Outcome results
Primary
UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)
Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training | UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity) | 82.7 units on a scale | Standard Deviation 8.7 |
| Standard Pharmacotherapy | UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity) | 84.4 units on a scale | Standard Deviation 8 |
Secondary
Hopkins Verbal Learning Test Percent Retained
Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial. Score ranges from 0-100. Higher scores represent better performance.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training | Hopkins Verbal Learning Test Percent Retained | 93.4 units on a scale | Standard Deviation 21.6 |
| Standard Pharmacotherapy | Hopkins Verbal Learning Test Percent Retained | 85.9 units on a scale | Standard Deviation 19.4 |