NCT01477125

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

4.1 years

First QC Date

November 15, 2011

Last Update Submit

September 2, 2020

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

adhdadultsworking memorytrainingRCT

Outcome Measures

Primary Outcomes (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

    Baseline and 7 weeks

Secondary Outcomes (13)

  • Change in a composite measure of working memory capacity

    Baseline and 31 weeks

  • Change in Digit Span Forwards/Backwards score

    Baseline, 7 and 31 weeks

  • Change in Span Board Forwards/Backwards score

    Baseline, 7 and 31 weeks

  • Change in Arithmetics score

    Baseline, 7 and 31 weeks

  • Change in Spatial Working Memory score

    Baseline, 7 and 31 weeks

  • +8 more secondary outcomes

Study Arms (2)

Flex working memory training

EXPERIMENTAL

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

Behavioral: Flex working memory training

Control version of Flex

PLACEBO COMPARATOR

30-40 minutes of training with a control version of Flex, 5 days a week for 5 weeks.

Behavioral: Flex working memory training

Interventions

Flex working memory trainingBEHAVIORAL

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

Control version of FlexFlex working memory training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ylva Ginsberg, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Henrik Larsson, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant psychiatrist, clinical postdoc

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 22, 2011

Study Start

November 1, 2013

Primary Completion

December 15, 2017

Study Completion

June 15, 2018

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

SE(1)