NCT01271413

Brief Summary

This research is being done to learn if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking. The study will compare the effects of different versions of the computer tasks. It also will compare the task performance of different groups of people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2010

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

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 7, 2014

Completed
Last Updated

April 16, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

January 5, 2011

Results QC Date

November 23, 2013

Last Update Submit

March 25, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Working Memory

    Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks

    baseline, 7 weeks

Secondary Outcomes (6)

  • Episodic Memory

    baseline, 7 weeks

  • Trail-making

    baseline, 7 weeks

  • go/No-go

    baseline, 7 weeks

  • Addiction Severity Index

    baseline, 7 weeks

  • Delay Discounting

    baseline, 7 weeks

  • +1 more secondary outcomes

Study Arms (2)

Adaptive cognitively stimulating activities

EXPERIMENTAL
Behavioral: Computerized cognitively stimulating activities

Non-adaptive cognitively stimulating activities

ACTIVE COMPARATOR
Behavioral: Computerized cognitively stimulating activities

Interventions

The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.

Adaptive cognitively stimulating activitiesNon-adaptive cognitively stimulating activities

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-55
  • in methadone maintenance or healthy volunteers
  • healthy

You may not qualify if:

  • Axis I disorder (except substance abuse and dependence in methadone maintenance patients)
  • severe cognitive impairment
  • serious untreated medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BPRU, Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Rass O, Schacht RL, Buckheit K, Johnson MW, Strain EC, Mintzer MZ. A randomized controlled trial of the effects of working memory training in methadone maintenance patients. Drug Alcohol Depend. 2015 Nov 1;156:38-46. doi: 10.1016/j.drugalcdep.2015.08.012. Epub 2015 Aug 24.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Miriam Mintzer
Organization
Johns Hopkins University School of Medicine

Study Officials

  • Miriam Z Mintzer, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

December 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 16, 2014

Results First Posted

March 7, 2014

Record last verified: 2014-03

Locations