Substance AbusePhase 2NCT02068261
Working Memory Training in Adults With Substance Abuse and Executive Function Deficits.
A Phase 2 study testing Computerized Cogmed working memory training and Treatment as usual in people with Substance Abuse and Executive Dysfunction, run by Örebro Läns Landsting at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Substance Abuse, Executive Dysfunction, Anxiety
- What is being tested?
- Computerized Cogmed working memory training and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment seeking adults with substance abuse and executive function deficits.
Who cannot join
- Acute intoxication or abstinence symptoms of any substance.
- Psychosis.
Trial locations and contacts
1 site in 1 country.
Rickard Ahlberg, doctoral student contact
Kurt Skårberg, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Psychiatric Research Centre
Örebro, Örebro County, 701 16
Rickard Ahlberg, doctoral student, rickard.ahlberg@orebroll.se
Lars Kjellin, docent
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Abuse, Executive Dysfunction, Anxiety, Depression, Antisocial Personality, Reading Disabilities
- Being tested
- Computerized Cogmed working memory training, Treatment as usual
- Medical subject headings
- Substance-Related Disorders, Anxiety Disorders, Depression, Antisocial Personality Disorder, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cogmed working memory trainingBehavioural
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.
Treatment as usualBehavioural
Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment.
| Study group | Role | What they receive |
|---|---|---|
| Cogmed working memory training | Experimental | 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. Receives: Behavioral: Computerized Cogmed working memory training |
| Treatment as usual | Active comparator | 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in substance abuse measured with Substance abuse scales in Adult Self Report (ASR; ASEBA).
Measured: Baseline and at 25 weeks
Secondary outcomes (10)
Change from baseline in Adult Self Report (ASR; ASEBA) Attention problems scale.
Measured: Baseline and at 25 weeks
Change from baseline in Adult Self Report (ASR; ASEBA) Internalizing index.
Measured: Baseline and at 25 weeks
Change from baseline in Adult Self Report (ASR; ASEBA) Externalizing index.
Measured: Baseline and at 25 weeks
Change from baseline in Adult Self Report (ASR; ASEBA) Adaptive functioning scales.
Measured: Baseline and at 25 weeks
Change from baseline in Executive functioning measured with Behavior Rating Inventory of Executive Function-Adult (BRIEF-A).
Measured: Baseline and at 25 weeks
Change from baseline in verbal working memory measured with performance on Digit span.
Measured: Baseline and at 25 weeks
Change from baseline in visual working memory measured with performance on Span board.
Measured: Baseline and at 25 weeks
Change from baseline in focused attention measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Measured: Baseline and at 25 weeks
Change from baseline in vigilance measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Measured: 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).
Measured: Baseline and at 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro Läns Landsting
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rickard Ahlberg, Örebro Läns Landsting
- Investigators
- Lars Kjellin, Docent, Study director, Örebro Läns Landsting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068261
- Sponsor's protocol ID
- RA02
- Status last verified
- Oct 2015
- First submitted
- 19 Feb 2014
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Working Memory Training in Adults With Substance Abuse and Executive Function Deficits: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02068261
- Acronym / sponsor ID
- RA02
- Conditions
- Substance Abuse, Executive Dysfunction, Anxiety, Depression, Antisocial Personality, Reading Disabilities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Örebro Läns LandstingOther government
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cogmed working memory training | Experimental | Behavioral: Computerized Cogmed working memory training30-40 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. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Treatment seeking adults with substance abuse and executive function deficits.
Key exclusion criteria (2 listed)
- Acute intoxication or abstinence symptoms of any substance.
- Psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cogmed working memory trainingComputerized 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. | Behavioural | Cogmed working memory training |
| Treatment as usualTreatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment. | Behavioural | Treatment as usual |
Primary outcome
Change from baseline in substance abuse measured with Substance abuse scales in Adult Self Report (ASR; ASEBA).
Time frame: Baseline and at 25 weeks
10 secondary outcomes
Change from baseline in Adult Self Report (ASR; ASEBA) Attention problems scale.
Time frame: Baseline and at 25 weeks
Change from baseline in Adult Self Report (ASR; ASEBA) Internalizing index.
Time frame: Baseline and at 25 weeks
Change from baseline in Adult Self Report (ASR; ASEBA) Externalizing index.
Time frame: Baseline and at 25 weeks
Change from baseline in Adult Self Report (ASR; ASEBA) Adaptive functioning scales.
Time frame: 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
Change from baseline in verbal working memory measured with performance on Digit span.
Time frame: Baseline and at 25 weeks
Change from baseline in visual working memory measured with performance on Span board.
Time frame: 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
Change from baseline in vigilance measured with performance on Conners Continuous Performance Test-II (CCPT-II).
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rickard Ahlberg, doctoral student contact
Kurt Skårberg, MD contact
Lars Kjellin, Docent study director
Örebro Läns Landsting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computerized Cogmed working memory training and Treatment as usual in people with Substance Abuse and Executive Dysfunction, run by Örebro Läns Landsting at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rickard Ahlberg, doctoral student (rickard.ahlberg@orebroll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in substance abuse measured with Substance abuse scales in Adult Self Report (ASR; ASEBA). (time frame: Baseline and at 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.