Trial Outcomes & Findings for Cognitive Training for Patients With Schizophrenia (NCT NCT01521026)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

3 months

Results posted on

2023-07-05

Participant Flow

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.

Baseline data were collected before randomization.

Participant milestones

Participant milestones
Measure	Cognitive Training Cognitive training group	Standard Pharmacotherapy Standard pharmacotherapy with regular clinician
Overall Study STARTED	38	31
Overall Study COMPLETED	23	28
Overall Study NOT COMPLETED	15	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Training for Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Training n=38 Participants Cognitive training group	Standard Pharmacotherapy n=31 Participants standard pharmacotherapy with regular clinician	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	44.3 years STANDARD_DEVIATION 10.1 • n=5 Participants	48.8 years STANDARD_DEVIATION 8.7 • n=7 Participants	46.3 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	31 participants n=7 Participants	69 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=19 Participants Cognitive training group	Standard Pharmacotherapy n=23 Participants Standard pharmacotherapy with the regular clinician
UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)	82.7 units on a scale Standard Deviation 8.7	84.4 units on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=20 Participants Cognitive training group	Standard Pharmacotherapy n=24 Participants Standard pharmacotherapy with the regular clinician
Hopkins Verbal Learning Test Percent Retained	93.4 units on a scale Standard Deviation 21.6	85.9 units on a scale Standard Deviation 19.4

Adverse Events

Cognitive Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Pharmacotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Twamley, PhD

UCSD

Phone: 6195436684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place