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
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Behavioral: Flex working memory training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computerised Working Memory Training in Adults With ADHD: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477125

Locations
Sweden
Karolinska Institutet Not yet recruiting
Stockholm, Sweden, 171 77
Contact: Ylva Ginsberg, MD, PhD    +46 8 5248 23 98    ylva.ginsberg@ki.se   
Principal Investigator: Ylva Ginsberg, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
PRIMA Child- and Adult Psychiatry, Stockholm, Sweden
The Söderströmska-Königska Foundation
Investigators
Principal Investigator: Ylva Ginsberg, MD, PhD Karolinska Institutet
Study Director: Henrik Larsson, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Ylva Ginsberg, MD, PhD, Senior consultant psychiatrist, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01477125     History of Changes
Other Study ID Numbers: X002, DAT1 PRIMA
Study First Received: November 15, 2011
Last Updated: October 28, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
adhd
adults
working memory
training
RCT

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014