Working Memory Training in Adults With ADHD

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2015 by Karolinska Institutet

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

ClinicalTrials.gov Identifier:

NCT01477125

First received: November 15, 2011

Last updated: September 29, 2015

Last verified: September 2015

History of Changes

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, from psychiatric outpatient clinics (N=100) as well as from a high-security prison facility (N=50).

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:

MedlinePlus related topics: Memory

U.S. FDA Resources

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:	150
Study Start Date:	November 2013
Estimated Study Completion Date:	June 2017
Estimated Primary Completion Date:	December 2016 (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.	Behavioral: Flex working memory training 30-40 minutes of working memory training, 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 (Adult)
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	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


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 DAT-KV
Study First Received:	November 15, 2011
Last Updated:	September 29, 2015
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 Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016

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