Working Memory Training in Adults With ADHD

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT01477125

Collaborator

Region Stockholm (Other), Swedish Prison and Probation Services (Other), The Söderströmska-Königska Foundation (Other)

102

Enrollment

Location

Arms

55.4

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Behavioral: Flex working memory training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Dec 15, 2017

Actual Study Completion Date :

Jun 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change in a composite measure of working memory capacity [Baseline and 7 weeks]
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 [Baseline and 31 weeks]
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 [Baseline, 7 and 31 weeks]
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 [Baseline, 7 and 31 weeks]
Evaluating changes in both Span Board forwards and backwards scores as measures of simple visuo-spatial working memory capacity.
Change in Arithmetics score [Baseline, 7 and 31 weeks]
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 [Baseline, 7 and 31 weeks]
Evaluating change in Spatial Working Memory score as a measure of complex visuo-spatial working memory capacity.
Change in Qbtest scores [Baseline, 7 and 31 weeks]
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 [Baseline, 7 and 31 weeks]
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 [Baseline, 7, 19, and 31 weeks]
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) [Baseline, 7, 19, and 31 weeks]
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 [Baseline, 7, 19, and 31 weeks]
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) [Baseline, 7, 19, and 31 weeks]
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) [Baseline and 7 weeks]
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 [Baseline and 7 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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).