Working Memory Training in Adults With ADHD
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ClinicalTrials.gov Identifier: NCT01477125 |
Recruitment Status
: Unknown
Verified September 2015 by Ylva Ginsberg, MD, PhD, Karolinska Institutet.
Recruitment status was: Recruiting
First Posted
: November 22, 2011
Last Update Posted
: October 1, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Attention Deficit Hyperactivity Disorder | Behavioral: Flex working memory training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Computerised Working Memory Training in Adults With ADHD: A Randomised Controlled Trial |
Study Start Date : | November 2013 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | June 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Flex working memory training
30-40 minutes of working memory training, 5 days a week for 5 weeks
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Behavioral: Flex working memory training
30-40 minutes of working memory training, 5 days a week for 5 weeks
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Placebo Comparator: Control version of Flex
30-40 minutes of training with a control version of Flex, 5 days a week for 5 weeks.
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Behavioral: Flex working memory training
30-40 minutes of working memory training, 5 days a week for 5 weeks
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- Change in a composite measure of working memory capacity [ Time Frame: Baseline and 7 weeks ]
The composite measure of working memory capacity comprises the sum score of:
- Digit Span score (forwards/backwards)
- Span Board score (forwards/backwards)
- Arithmetics score
- Spatial Working Memory score
- Change in a composite measure of working memory capacity [ Time Frame: Baseline and 31 weeks ]The composite measure of working memory capacity will be assessed in a 6-month follow-up conducted at week 31 post-baseline, equivalent to week 24 post-intervention, to assess retention of any training-related improvements.
- Change in Digit Span Forwards/Backwards score [ Time Frame: Baseline, 7 and 31 weeks ]Evaluating changes in both Digit Span forwards and backwards scores, as measures of simple verbal working memory capacity.
- Change in Span Board Forwards/Backwards score [ Time Frame: Baseline, 7 and 31 weeks ]Evaluating changes in both Span Board forwards and backwards scores as measures of simple visuo-spatial working memory capacity.
- Change in Arithmetics score [ Time Frame: Baseline, 7 and 31 weeks ]Evaluating change in Arithmetics score, as a measure of complex verbal working memory capacity as well as of mathematics ability.
- Change in Spatial Working Memory score [ Time Frame: Baseline, 7 and 31 weeks ]Evaluating change in Spatial Working Memory score as a measure of complex visuo-spatial working memory capacity.
- Change in Qbtest scores [ Time Frame: Baseline, 7 and 31 weeks ]Evaluating changes in Qbtest, a computerised CPT that in addition to measuring inattention and impulsivity also captures motor activity by an IR device during performance of the CPT.
- Change in Raven´s Standard Progressive Matrices score [ Time Frame: Baseline, 7 and 31 weeks ]Evaluating change in score of a short version of Raven´s Standard Progressive Matrices, as a measure of fluid intelligence.
- Change in Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist [ Time Frame: Baseline, 7, 19, and 31 weeks ]Evaluating changes in ADHD symptoms by self-reported and informant-reported (significant other) versions of ASRS-v1.1, conducted at baseline, post-intervention, at 3-month and 6-month follow-up.
- Change in Sheehan Disability Scale (SDS) [ Time Frame: Baseline, 7, 19, and 31 weeks ]Evaluating changes in psychosocial functioning by the self-reported SDS conducted at baseline, post-intervention, at 3-month and 6-month follow-up.
- Change in EuroQol- 5 Dimensions (EQ-5D) questionnaire [ Time Frame: Baseline, 7, 19, and 31 weeks ]Evaluating change in health-related quality of life by the self-reported generic QoL questionnaire EQ-5D, conducted at baseline, post-intervention, at 3-month and 6-month follow-up.
- Change in Adult ADHD Quality of Life Measure (AAQoL) [ Time Frame: Baseline, 7, 19, and 31 weeks ]Evaluating change in health-related quality of life by the self-reported ADHD specific QoL measure AAQoL, conducted at baseline, post-intervention, at 3-month and 6-month follow-up.
- Montgomery Åsberg Depression Rating Scale-Self report (MADRS-S) [ Time Frame: Baseline and 7 weeks ]Evaluating if depressive symptoms during the training period, as measured by the self-reported MADRS-S will influence adherence to and results of the working memory training.
- Adverse events [ Time Frame: Baseline and 7 weeks ]All adverse events that occurred during the course of the 5-week intervention will be collected as part of the post-intervention assessments at week 7.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed ADHD according to DSM-IV criteria; ADHD combined type, ADHD inattentive type or ADHD UNS, primarily inattentive type.
- Unmedicated for ADHD during the course of the trial, or being under stable ADHD medication for at least one month at baseline visit and without any planned changes in medication until post-study assessments have taken place.
Exclusion Criteria:
- Previous participation in computerised working memory training (completed training).
- Any psychiatric disorder that in the judgment of the investigator, may interfere with study participation and/or study assessments, also including current substance abuse.
- Participation in psychological treatment addressing ADHD during the course of the 5-week training period (psychoeducation is accepted).
- Initiation of psychological treatment for coexistent disorders during the course of the study (treatment already ongoing at baseline visit is accepted if there are no planned changes during the 5-week training period).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477125
Sweden | |
Karolinska Institutet | Recruiting |
Stockholm, Sweden, 171 77 | |
Contact: Ylva Ginsberg, MD, PhD +46 8 1234 8500 ylva.ginsberg@ki.se | |
Principal Investigator: Ylva Ginsberg, MD, PhD |
Principal Investigator: | Ylva Ginsberg, MD, PhD | Karolinska Institutet | |
Study Director: | Henrik Larsson, PhD | Karolinska Institutet |
Responsible Party: | Ylva Ginsberg, MD, PhD, Senior consultant psychiatrist, clinical postdoc, Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT01477125 History of Changes |
Other Study ID Numbers: |
X002 DAT-NSP ( Other Identifier: Karolinska Institutet ) DAT-KV ( Other Identifier: Karolinska Institutet ) |
First Posted: | November 22, 2011 Key Record Dates |
Last Update Posted: | October 1, 2015 |
Last Verified: | September 2015 |
Keywords provided by Ylva Ginsberg, MD, PhD, Karolinska Institutet:
adhd adults working memory training RCT |
Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders |