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Attention Deficit Hyperactivity DisorderNCT01477125

Working Memory Training in Adults With ADHD

A study testing Flex working memory training in people with Attention Deficit Hyperactivity Disorder, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate whether computerised working memory training improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a high-security prison facility (N=50). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
Flex working memory training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteSweden
Study dates
Nov 2013to 15 Jun 2018
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet

    Stockholm, 171 77

Other trials in Sweden

About this study

Official title: Computerised Working Memory Training in Adults With ADHD: A Randomised Controlled Trial

The purpose of this study is to evaluate whether computerised working memory training improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a high-security prison facility (N=50).

Read the detailed description

The primary aim is to evaluate whether 5 weeks of computerised working memory training improves working memory capacity. Secondary aims are to explore whether improvements in working memory capacity will be transferred to improvements in learning abilities and fluid intelligence. Also, far transfer effects on executive functioning, ADHD symptoms, psychosocial functioning and quality of life will be explored. Finally, it will also be assessed to what extent improvements gained from 5 weeks of working memory training will be maintained 3 and 6 months post-study, respectively.

Being tested
Flex working memory training
Keywords
adhd, adults, working memory, training, RCT
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flex working memory trainingBehavioural

    30-40 minutes of working memory training, 5 days a week for 5 weeks

Study groups in NCT01477125
Study groupRoleWhat they receive
Flex working memory trainingExperimental30-40 minutes of working memory training, 5 days a week for 5 weeks
Receives: Behavioral: Flex working memory training
Control version of FlexPlacebo comparator30-40 minutes of training with a control version of Flex, 5 days a week for 5 weeks.
Receives: Behavioral: Flex working memory training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in a composite measure of working memory capacity

    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

    Measured: Baseline and 7 weeks

Secondary outcomes (13)

  1. Change in a composite measure of working memory capacity

    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.

    Measured: Baseline and 31 weeks

  2. Change in Digit Span Forwards/Backwards score

    Evaluating changes in both Digit Span forwards and backwards scores, as measures of simple verbal working memory capacity.

    Measured: Baseline, 7 and 31 weeks

  3. Change in Span Board Forwards/Backwards score

    Evaluating changes in both Span Board forwards and backwards scores as measures of simple visuo-spatial working memory capacity.

    Measured: Baseline, 7 and 31 weeks

  4. Change in Arithmetics score

    Evaluating change in Arithmetics score, as a measure of complex verbal working memory capacity as well as of mathematics ability.

    Measured: Baseline, 7 and 31 weeks

  5. Change in Spatial Working Memory score

    Evaluating change in Spatial Working Memory score as a measure of complex visuo-spatial working memory capacity.

    Measured: Baseline, 7 and 31 weeks

  6. Change in Qbtest scores

    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.

    Measured: Baseline, 7 and 31 weeks

  7. Change in Raven´s Standard Progressive Matrices score

    Evaluating change in score of a short version of Raven´s Standard Progressive Matrices, as a measure of fluid intelligence.

    Measured: Baseline, 7 and 31 weeks

  8. Change in Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist

    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.

    Measured: Baseline, 7, 19, and 31 weeks

  9. Change in Sheehan Disability Scale (SDS)

    Evaluating changes in psychosocial functioning by the self-reported SDS conducted at baseline, post-intervention, at 3-month and 6-month follow-up.

    Measured: Baseline, 7, 19, and 31 weeks

  10. Change in EuroQol- 5 Dimensions (EQ-5D) questionnaire

    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.

    Measured: Baseline, 7, 19, and 31 weeks

  11. Change in Adult ADHD Quality of Life Measure (AAQoL)

    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.

    Measured: Baseline, 7, 19, and 31 weeks

  12. Montgomery Åsberg Depression Rating Scale-Self report (MADRS-S)

    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.

    Measured: Baseline and 7 weeks

  13. Adverse events

    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.

    Measured: Baseline and 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2011 (estimated)
  2. Study startNov 2013
  3. Primary completion15 Dec 2017
  4. Study completion15 Jun 2018

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01477125
Sponsor's protocol ID
X002
Other IDs
DAT-NSP, DAT-KV
Status last verified
Sep 2020
First submitted
15 Nov 2011
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Flex working memory training in people with Attention Deficit Hyperactivity Disorder, run by Karolinska Institutet 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 3 Sep 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in a composite measure of working memory capacity (time frame: Baseline and 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01477125.

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 3 Sep 2020.

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Working Memory Training in Adults With ADHD | AzTrials