NCT01521026

Brief Summary

This research on cognitive training addresses the following questions:

  1. 1.Does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses?
  2. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 11, 2013

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

5.9 years

First QC Date

January 22, 2012

Results QC Date

July 1, 2013

Last Update Submit

June 30, 2023

Conditions

SchizophreniaSchizoaffective DisorderOther Primary Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Hopkins Verbal Learning Test Percent Retained

    3 months

Study Arms (2)

Cognitive Training

EXPERIMENTAL

Cognitive training group

Behavioral: Cognitive Training

Standard Pharmacotherapy

NO INTERVENTION

Interventions

Cognitive TrainingBEHAVIORAL

12-week compensatory cognitive training in group format

Cognitive Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary psychotic disorder (including schizophrenia, schizoaffective disorder, psychotic mood disorder, or psychosis NOS)
  • Age 18 or older
  • Fluency in English

You may not qualify if:

  • Dementia
  • Neurological conditions affecting cognition
  • Mental retardation
  • Substance use disorder within the past month
  • Participation in other intervention trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Outpatient Psychiatric Services

San Diego, California, 92103, United States

Location

Related Publications (1)

  • Twamley EW, Vella L, Burton CZ, Heaton RK, Jeste DV. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1212-9. doi: 10.4088/JCP.12m07686. Epub 2012 Aug 7.

    PMID: 22939029DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

* small sample size * relatively short follow-up period * significant dropout rate * did not use an active control condition that matched CCT for therapist time or group involvement

Results Point of Contact

Title
Elizabeth Twamley, PhD
Organization
UCSD
etwamley@ucsd.edu
6195436684

Study Officials

  • Elizabeth W Twamley, PhD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

January 22, 2012

First Posted

January 30, 2012

Study Start

September 1, 2003

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 5, 2023

Results First Posted

December 11, 2013

Record last verified: 2023-06

Locations

US(1)