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Completed

NCT Number: NCT01477125

Working Memory Training in Adults With ADHD

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).

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 171 77, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Flex working memory training

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm
  • Swedish Prison and Probation Services
  • The Söderströmska-Königska Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Nov 22, 2011
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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