- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02068261
Working Memory Training in Adults With Substance Abuse and Executive Function Deficits.
October 22, 2015 updated by: Rickard Ahlberg, Örebro Läns Landsting
Computerized Working Memory Training in Adults With Substance Abuse and Executive Function Deficits: A Randomised Controlled Trial.
The purpose of this study is to evaluate the effects of a computerized working memory training program on substance abuse, psychosocial functioning, cognitive performance and psychiatric problems in adults with substance abuse and attention problems.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The primary aim of this study is to examine the effects of 5 weeks of computerized working memory training on substance abuse.
Secondary aims are to explore whether effects are mediated by changes in executive functions and/or moderated by personality.
Also, effects on measures of psychosocial functioning, depression, anxiety and attention will be explored.
Follow-up assessment will be conducted at 6 months post training.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Örebro, Sweden, 701 16
- Recruiting
- Psychiatric Research Centre
-
Contact:
- Rickard Ahlberg, doctoral student
- Email: rickard.ahlberg@orebroll.se
-
Principal Investigator:
- Lars Kjellin, docent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Treatment seeking adults with substance abuse and executive function deficits.
Exclusion Criteria:
- Acute intoxication or abstinence symptoms of any substance.
- Psychosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cogmed working memory training
30-40 minutes of Cogmed computerized working memory training 3-5 days a week for 5-8 weeks.
Every training session consists of a set of visual- and verbal working memory tasks that are trained on during the session.
|
Computerized working memory training with Cogmed QM software.
The QM software consists of a set of verbal and visual working memory tasks which is trained for 25-40 minutes each session.
|
|
Active Comparator: Treatment as usual
Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment.
After a 8 week period participants in this arm well be offered Cogmed working memory training.
|
Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in substance abuse measured with Substance abuse scales in Adult Self Report (ASR; ASEBA).
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in Adult Self Report (ASR; ASEBA) Attention problems scale.
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
|
Change from baseline in Adult Self Report (ASR; ASEBA) Internalizing index.
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
|
Change from baseline in Adult Self Report (ASR; ASEBA) Externalizing index.
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
|
Change from baseline in Adult Self Report (ASR; ASEBA) Adaptive functioning scales.
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
|
Change from baseline in Executive functioning measured with Behavior Rating Inventory of Executive Function-Adult (BRIEF-A).
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
|
Change from baseline in verbal working memory measured with performance on Digit span.
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
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Change from baseline in visual working memory measured with performance on Span board.
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
|
Change from baseline in focused attention measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
|
Change from baseline in vigilance measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
|
Change from baseline in reading speed measured with performance on Reading speed in Diagnostic Reading and Writing Test (DLS; Swedish version).
Time Frame: Baseline and at 25 weeks
|
Baseline and at 25 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lars Kjellin, Docent, Orebro lans landsting
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
February 19, 2014
First Submitted That Met QC Criteria
February 20, 2014
First Posted (Estimate)
February 21, 2014
Study Record Updates
Last Update Posted (Estimate)
October 23, 2015
Last Update Submitted That Met QC Criteria
October 22, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Personality Disorders
- Neurodevelopmental Disorders
- Language Disorders
- Communication Disorders
- Learning Disabilities
- Substance-Related Disorders
- Antisocial Personality Disorder
- Dyslexia
Other Study ID Numbers
- RA02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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