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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
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Swedish Prison and Probation Services
The Söderströmska-Königska Foundation
Information provided by (Responsible Party):
Ylva Ginsberg, MD, PhD, Karolinska Institutet

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Flex working memory training Not Applicable

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Flex working memory training
30-40 minutes of working memory training, 5 days a week for 5 weeks
 Behavioral: Flex working memory training
30-40 minutes of working memory training, 5 days a week for 5 weeks
Placebo Comparator: Control version of Flex
30-40 minutes of training with a control version of Flex, 5 days a week for 5 weeks.
 Behavioral: Flex working memory training
30-40 minutes of working memory training, 5 days a week for 5 weeks


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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         
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Swedish Prison and Probation Services
The Söderströmska-Königska Foundation
Investigators
Principal Investigator: Ylva Ginsberg, MD, PhD Karolinska Institutet
Study Director: Henrik Larsson, PhD Karolinska Institutet
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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