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Working Memory Training in Adults With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Flex working memory training
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring adhd, adults, working memory, training, RCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Flex working memory training

Control version of Flex

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in a composite measure of working memory capacity
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
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
Evaluating changes in both Span Board forwards and backwards scores as measures of simple visuo-spatial working memory capacity.
Change in Arithmetics score
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
Evaluating change in Spatial Working Memory score as a measure of complex visuo-spatial working memory capacity.
Change in Qbtest scores
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
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
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)
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
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)
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)
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
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.

Full Information

First Posted
November 15, 2011
Last Updated
September 2, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Swedish Prison and Probation Services, The Söderströmska-Königska Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01477125
Brief Title
Working Memory Training in Adults With ADHD
Official Title
Computerised Working Memory Training in Adults With ADHD: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Swedish Prison and Probation Services, The Söderströmska-Königska Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
adhd, adults, working memory, training, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flex working memory training
Arm Type
Experimental
Arm Description
30-40 minutes of working memory training, 5 days a week for 5 weeks
Arm Title
Control version of Flex
Arm Type
Placebo Comparator
Arm Description
30-40 minutes of training with a control version of Flex, 5 days a week for 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Flex working memory training
Intervention Description
30-40 minutes of working memory training, 5 days a week for 5 weeks
Primary Outcome Measure Information:
Title
Change in a composite measure of working memory capacity
Description
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
Time Frame
Baseline and 7 weeks
Secondary Outcome Measure Information:
Title
Change in a composite measure of working memory capacity
Description
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.
Time Frame
Baseline and 31 weeks
Title
Change in Digit Span Forwards/Backwards score
Description
Evaluating changes in both Digit Span forwards and backwards scores, as measures of simple verbal working memory capacity.
Time Frame
Baseline, 7 and 31 weeks
Title
Change in Span Board Forwards/Backwards score
Description
Evaluating changes in both Span Board forwards and backwards scores as measures of simple visuo-spatial working memory capacity.
Time Frame
Baseline, 7 and 31 weeks
Title
Change in Arithmetics score
Description
Evaluating change in Arithmetics score, as a measure of complex verbal working memory capacity as well as of mathematics ability.
Time Frame
Baseline, 7 and 31 weeks
Title
Change in Spatial Working Memory score
Description
Evaluating change in Spatial Working Memory score as a measure of complex visuo-spatial working memory capacity.
Time Frame
Baseline, 7 and 31 weeks
Title
Change in Qbtest scores
Description
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.
Time Frame
Baseline, 7 and 31 weeks
Title
Change in Raven´s Standard Progressive Matrices score
Description
Evaluating change in score of a short version of Raven´s Standard Progressive Matrices, as a measure of fluid intelligence.
Time Frame
Baseline, 7 and 31 weeks
Title
Change in Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist
Description
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.
Time Frame
Baseline, 7, 19, and 31 weeks
Title
Change in Sheehan Disability Scale (SDS)
Description
Evaluating changes in psychosocial functioning by the self-reported SDS conducted at baseline, post-intervention, at 3-month and 6-month follow-up.
Time Frame
Baseline, 7, 19, and 31 weeks
Title
Change in EuroQol- 5 Dimensions (EQ-5D) questionnaire
Description
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.
Time Frame
Baseline, 7, 19, and 31 weeks
Title
Change in Adult ADHD Quality of Life Measure (AAQoL)
Description
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.
Time Frame
Baseline, 7, 19, and 31 weeks
Title
Montgomery Åsberg Depression Rating Scale-Self report (MADRS-S)
Description
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.
Time Frame
Baseline and 7 weeks
Title
Adverse events
Description
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.
Time Frame
Baseline and 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ylva Ginsberg, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Larsson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden

12. IPD Sharing Statement

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Working Memory Training in Adults With ADHD

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