Working Memory Training in Adults With ADHD

Study Overview
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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.

Official Title
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Computerised Working Memory Training in Adults With ADHD: A Randomised Controlled Trial

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Flex working memory training


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flex working memory training<br>30-40 minutes of working memory training, 5 days a week for 5 weeks | Behavioral: Flex working memory training<br>* 30-40 minutes of working memory training, 5 days a week for 5 weeks<br>|
| Placebo Comparator: Control version of Flex<br>30-40 minutes of training with a control version of Flex, 5 days a week for 5 weeks. | Behavioral: Flex working memory training<br>* 30-40 minutes of working memory training, 5 days a week for 5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 31 weeks | 
| 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. | Baseline, 7 and 31 weeks | 
| 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. | Baseline, 7 and 31 weeks | 
| Change in Arithmetics score | Evaluating change in Arithmetics score, as a measure of complex verbal working memory capacity as well as of mathematics ability. | Baseline, 7 and 31 weeks | 
| Change in Spatial Working Memory score | Evaluating change in Spatial Working Memory score as a measure of complex visuo-spatial working memory capacity. | Baseline, 7 and 31 weeks | 
| 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. | Baseline, 7 and 31 weeks | 
| 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. | Baseline, 7 and 31 weeks | 
| 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. | Baseline, 7, 19, and 31 weeks | 
| 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. | Baseline, 7, 19, and 31 weeks | 
| 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. | Baseline, 7, 19, and 31 weeks | 
| 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. | Baseline, 7, 19, and 31 weeks | 
| 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. | Baseline and 7 weeks | 
| 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. | Baseline and 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adults, RCT, adhd, working memory, training