Clinical trial NCT01477125: Working Memory Training in Adults With ADHD
Official title: Computerised Working Memory Training in Adults With ADHD: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: adhd
adults
working memory
training
RCT
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Swedish Prison and Probation Services
name: The Söderströmska-Königska Foundation
First posted: 2011-11-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in a composite measure of working memory capacity
timeFrame: Baseline and 7 weeks
Secondary outcomes:
measure: Change in a composite measure of working memory capacity
timeFrame: Baseline and 31 weeks
measure: Change in Digit Span Forwards/Backwards score
timeFrame: Baseline, 7 and 31 weeks
measure: Change in Span Board Forwards/Backwards score
timeFrame: Baseline, 7 and 31 weeks
measure: Change in Arithmetics score
timeFrame: Baseline, 7 and 31 weeks
measure: Change in Spatial Working Memory score
timeFrame: Baseline, 7 and 31 weeks
measure: Change in Qbtest scores
timeFrame: Baseline, 7 and 31 weeks
measure: Change in Raven´s Standard Progressive Matrices score
timeFrame: Baseline, 7 and 31 weeks
measure: Change in Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist
timeFrame: Baseline, 7, 19, and 31 weeks
measure: Change in Sheehan Disability Scale (SDS)
timeFrame: Baseline, 7, 19, and 31 weeks
measure: Change in EuroQol- 5 Dimensions (EQ-5D) questionnaire
timeFrame: Baseline, 7, 19, and 31 weeks
measure: Change in Adult ADHD Quality of Life Measure (AAQoL)
timeFrame: Baseline, 7, 19, and 31 weeks
measure: Montgomery Åsberg Depression Rating Scale-Self report (MADRS-S)
timeFrame: Baseline and 7 weeks
measure: Adverse events
timeFrame: Baseline and 7 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Ylva Ginsberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Henrik Larsson, PhD
role: STUDY_DIRECTOR
References: