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Working Memory Training in Adults With ADHD (DAT1-PRIMA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Karolinska Institutet
Sponsor:
Collaborators:
PRIMA Child- and Adult Psychiatry, Stockholm, Sweden
The Söderströmska-Königska Foundation
Information provided by (Responsible Party):
Ylva Ginsberg, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01477125
First received: November 15, 2011
Last updated: October 28, 2013
Last verified: October 2013

November 15, 2011
October 28, 2013
November 2013
December 2015   (final data collection date for primary outcome measure)
Change in a composite measure of working memory capacity [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]

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 from baseline in Working Memory Capacity at 8 weeks [ Time Frame: Baseline 3-6 days before training starts, post-training 14-27 days after completed training ] [ Designated as safety issue: No ]

    WMC is measured with:

    • Digit Span
    • Listening Span
    • Spanboard forward/backward
    • Operation Span
    • Continuous Performance Test (CPT-2)
  • Change from baseline in Working Memory Capacity at 30 weeks [ Time Frame: Baseline 3-6 days before training starts, post-training 168-171 days after completed training ] [ Designated as safety issue: No ]

    WMC is measured with:

    • Digit Span
    • Listening Span
    • Spanboard forward/backward
    • Operation Span
    • Continuous Performance Test (CPT-2)
Complete list of historical versions of study NCT01477125 on ClinicalTrials.gov Archive Site
  • Change in a composite measure of working memory capacity [ Time Frame: Baseline and 31 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • subjective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 14-27 days post-training ] [ Designated as safety issue: No ]
    • Adult ADHD Self-Report Scale (ASRS-v1.1)
    • Brown Attention-Deficit Disorder Scale (BADDS)
    • Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
  • Objective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 14-27 days post-training ] [ Designated as safety issue: No ]
    • Conners' Adult ADHD Rating Scale (CAARS)
    • KV-informantskattning which is based on the adhd DSM-IV criteria and specifically designed to fit the prison context in which staff is to rate study participants overt adhd symptoms
  • Global Impression [ Time Frame: Baseline 3-6 days before training, 14-27 days post-training ] [ Designated as safety issue: No ]
    • Clinical Global Impression - Severity (CGI-S)
    • Clinical Global Impression - Change (CGI-C), only at follow-up
    • Adult ADHD Quality of Life Measure (AAQoL)
    • EQ-5D self-report questionnaire
  • subjective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 84-87 days post-training ] [ Designated as safety issue: No ]
    • Adult ADHD Self-Report Scale (ASRS-v1.1)
    • Brown Attention-Deficit Disorder Scale (BADDS)
    • Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
  • subjective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 168-171 days post-training ] [ Designated as safety issue: No ]
    • Adult ADHD Self-Report Scale (ASRS-v1.1)
    • Brown Attention-Deficit Disorder Scale (BADDS)
    • Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
  • Global Impression [ Time Frame: Baseline 3-6 days before training, 84-87 days post-training ] [ Designated as safety issue: No ]
    • Clinical Global Impression - Severity (CGI-S)
    • Clinical Global Impression - Change (CGI-C)
    • Adult ADHD Quality of Life Measure (AAQoL)
    • EQ-5D self-report questionnaire
  • Global Impression [ Time Frame: Baseline 3-6 days before training, 168-171 days post-training ] [ Designated as safety issue: No ]
    • Clinical Global Impression - Severity (CGI-S)
    • Clinical Global Impression - Change (CGI-C)
    • Adult ADHD Quality of Life Measure (AAQoL)
    • EQ-5D self-report questionnaire
  • Objective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 84-87 days post-training ] [ Designated as safety issue: No ]
    • Conners' Adult ADHD Rating Scale (CAARS)
    • KV-informantskattning which is based on the adhd DSM-IV criteria and specifically designed to fit the prison context in which staff is to rate study participants overt adhd symptoms
  • Objective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 168-171 days post-training ] [ Designated as safety issue: No ]
    • Conners' Adult ADHD Rating Scale (CAARS)
    • KV-informantskattning which is based on the adhd DSM-IV criteria and specifically designed to fit the prison context in which staff is to rate study participants overt adhd symptoms
  • Distribution of polymorphic variance i DRD2, COMT and SNAP25 [ Time Frame: Once, 3-6 days before training ] [ Designated as safety issue: No ]
    Blood samples are taken with approval from participants.
Not Provided
Not Provided
 
Working Memory Training in Adults With ADHD
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
Behavioral: Flex working memory training
30-40 minutes of working memory training, 5 days a week for 5 weeks
  • Experimental: Flex working memory training
    30-40 minutes of working memory training, 5 days a week for 5 weeks
    Intervention: Behavioral: Flex working memory training
  • Placebo Comparator: Control version of Flex
    30-40 minutes of training with a control version of Flex, 5 days a week for 5 weeks.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2015
December 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
No
Sweden
 
NCT01477125
X002, DAT1 PRIMA
No
Ylva Ginsberg, MD, PhD, Karolinska Institutet
Karolinska Institutet
  • PRIMA Child- and Adult Psychiatry, Stockholm, Sweden
  • The Söderströmska-Königska Foundation
Principal Investigator: Ylva Ginsberg, MD, PhD Karolinska Institutet
Study Director: Henrik Larsson, PhD Karolinska Institutet
Karolinska Institutet
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP