Working Memory Training in Adults With ADHD

NCT ID: NCT01477125

Last Updated: 2020-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-06-15

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Flex working memory training

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

Group Type EXPERIMENTAL

Flex working memory training

Intervention Type BEHAVIORAL

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

Control version of Flex

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

Group Type PLACEBO_COMPARATOR

Flex working memory training

Intervention Type BEHAVIORAL

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

Interventions

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Flex working memory training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Swedish Prison and Probation Services

UNKNOWN

Sponsor Role collaborator

The Söderströmska-Königska Foundation

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Ylva Ginsberg, MD, PhD

Senior consultant psychiatrist, clinical postdoc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ylva Ginsberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Henrik Larsson, PhD

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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DAT-NSP

Identifier Type: OTHER

Identifier Source: secondary_id

DAT-KV

Identifier Type: OTHER

Identifier Source: secondary_id

X002

Identifier Type: -

Identifier Source: org_study_id

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