Computerised Training of Working Memory in an Adult Prison Population Diagnosed With Attention Deficit Hyperactivity Disorder (DAT1)

This study is not yet open for participant recruitment.
Verified November 2011 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Niklas Greback, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01477125
First received: November 15, 2011
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

The aim of the study is to test the primary hypothesis that computerised training of working memory will have a positive effect on working memory capacity in a population of adult prisoners diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). The secondary hypothesis is that effects of ADHD. Third hypothesis is that there will be a correlation between individuals gene variants, degree of ADHD symptoms and effects of working memory training.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Device: sham computerised training of working memory
Device: Computerised training of working memory ( Flex)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Controlled Randomized Double-blind Study of Training Effects From Computerised Training of Working Memory in a Population of Adult Prisoners Diagnosed With Adhd

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change from baseline in Working Memory Capacity at 8 weeks [ Time Frame: Baseline 3-6 days before training starts, post-training 14-27 days after completed training ] [ Designated as safety issue: No ]

    WMC is measured with:

    • Digit Span
    • Listening Span
    • Spanboard forward/backward
    • Operation Span
    • Continuous Performance Test (CPT-2)

  • Change from baseline in Working Memory Capacity at 30 weeks [ Time Frame: Baseline 3-6 days before training starts, post-training 168-171 days after completed training ] [ Designated as safety issue: No ]

    WMC is measured with:

    • Digit Span
    • Listening Span
    • Spanboard forward/backward
    • Operation Span
    • Continuous Performance Test (CPT-2)


Secondary Outcome Measures:
  • subjective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 14-27 days post-training ] [ Designated as safety issue: No ]
    • Adult ADHD Self-Report Scale (ASRS-v1.1)
    • Brown Attention-Deficit Disorder Scale (BADDS)
    • Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)

  • Objective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 14-27 days post-training ] [ Designated as safety issue: No ]
    • Conners' Adult ADHD Rating Scale (CAARS)
    • KV-informantskattning which is based on the adhd DSM-IV criteria and specifically designed to fit the prison context in which staff is to rate study participants overt adhd symptoms

  • Global Impression [ Time Frame: Baseline 3-6 days before training, 14-27 days post-training ] [ Designated as safety issue: No ]
    • Clinical Global Impression - Severity (CGI-S)
    • Clinical Global Impression - Change (CGI-C), only at follow-up
    • Adult ADHD Quality of Life Measure (AAQoL)
    • EQ-5D self-report questionnaire

  • subjective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 84-87 days post-training ] [ Designated as safety issue: No ]
    • Adult ADHD Self-Report Scale (ASRS-v1.1)
    • Brown Attention-Deficit Disorder Scale (BADDS)
    • Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)

  • subjective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 168-171 days post-training ] [ Designated as safety issue: No ]
    • Adult ADHD Self-Report Scale (ASRS-v1.1)
    • Brown Attention-Deficit Disorder Scale (BADDS)
    • Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)

  • Global Impression [ Time Frame: Baseline 3-6 days before training, 84-87 days post-training ] [ Designated as safety issue: No ]
    • Clinical Global Impression - Severity (CGI-S)
    • Clinical Global Impression - Change (CGI-C)
    • Adult ADHD Quality of Life Measure (AAQoL)
    • EQ-5D self-report questionnaire

  • Global Impression [ Time Frame: Baseline 3-6 days before training, 168-171 days post-training ] [ Designated as safety issue: No ]
    • Clinical Global Impression - Severity (CGI-S)
    • Clinical Global Impression - Change (CGI-C)
    • Adult ADHD Quality of Life Measure (AAQoL)
    • EQ-5D self-report questionnaire

  • Objective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 84-87 days post-training ] [ Designated as safety issue: No ]
    • Conners' Adult ADHD Rating Scale (CAARS)
    • KV-informantskattning which is based on the adhd DSM-IV criteria and specifically designed to fit the prison context in which staff is to rate study participants overt adhd symptoms

  • Objective adhd symptoms [ Time Frame: Baseline 3-6 days before training, 168-171 days post-training ] [ Designated as safety issue: No ]
    • Conners' Adult ADHD Rating Scale (CAARS)
    • KV-informantskattning which is based on the adhd DSM-IV criteria and specifically designed to fit the prison context in which staff is to rate study participants overt adhd symptoms

  • Distribution of polymorphic variance i DRD2, COMT and SNAP25 [ Time Frame: Once, 3-6 days before training ] [ Designated as safety issue: No ]
    Blood samples are taken with approval from participants.


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Working Memory Training Program Device: Computerised training of working memory ( Flex)
The experimental version will train working memory with increasingly more difficult tasks based on trainees performance.
Other Name: Flex
Placebo Comparator: Sham Working Memory Training Device: sham computerised training of working memory
Similar to experimental intervention but without the dynamic increase in difficulty during the course of training. Dynamic increase in difficulty is empirically found to be crucial in producing significant training effects on working memory.
Other Name: Flex

Detailed Description:

The prevalence of attention deficit/hyperactivity disorder (ADHD) is estimated to 3-4% among children/adolescents and 2-4% among adults. Although hyperactivity tends to be less prominent in the adult population, deficits in attention generally persists and may even get more salient with the natural process of aging. ADHD symptoms in children/adolescents are sometimes linked to behavioral dysfunction, e.g. conduct disorders, oppositional defiant disorder which in turn is precursors to antisocial personality disorder, drug abuse and criminality. Data shows a significant overrepresentation of ADHD related symptoms among the population within correctional facilities. The possible benefits of identifying and treating individuals with ADHD are extensive. Especially when the deficits can be considered a contributing factor to behavior causing great cost on a societal, as well as an individual level. Treatment of ADHD is preferably multimodal, i.e. consisting of more than one intervention. Medical treatment with central nervous system stimulants and Atomoxetine has so far the greatest scientific support as treatment for ADHD while Cognitive Behavior Therapy (CBT) and Dialectic Behavior Therapy (DBT)has somewhat less evidence. The need for new or complementary treatments is indisputable. Dysfunction in working memory capacity is a prominent feature in the clinical picture of attention deficits and therefore a key target in developing treatment. Studies have shown that working memory is not entirely a fixed feature of attention, but subject to plasticity and therefore possible to affect with training. Such training has been conducted with ADHD-diagnosed children/adolescents and have shown to produce statistically significant improvement in working memory capacity. We want to test the hypothesis that the same improvements can be achieved within an adult population. To the authors knowledge, no randomized, double-blind study of computerised training of working memory in adults has been done.

The primary research question is whether adults with ADHD, with or without ongoing medical treatment, can improve working memory capacity and if such potential improvement will generalize to other cognitive functions such as episodic memory, attention and impulsivity measured with neuropsychological tests. The secondary research question concerns the possible generalization of training effects to overt and covert ADHD symptoms, general function and perceived quality of life measured with questionnaires to study participants, prison staff and clinical investigators. Finally, we want to investigate the possible link between different genetic variants, degree of ADHD symptoms and effects of working memory training. Data indicate a possible link between differences in the polymorphic combinations of genes coding for dopamine receptors, i.e. DRD2, COMT and SNAP25, and regulation of working memory functions. Blood samples will be taken, with the study participants approval, and analysed for comparison with other data.

The study is randomized, controlled and double blind by design. Total number of participants is 50 divided into 2 groups. Experimental group receives training with a computerised program (FLEX) designed to enhance working memory by presenting tasks that demand effortful use of working memory functions. The program is dynamic, meaning that task difficulty will increase gradually following the trainees level of performance. Non-experimental group receives identical training but without the component of progressive increase in level of difficulty which has been shown to be a crucial factor in earlier studies on this type of training. Each participant receives training in 30-40 minute sessions, 5 days per week over 5 weeks. The training is supervised by prison staff who have been adequately instructed by study investigators.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with ADHD according to DSM-IV criteria, either combined type or predominantly inattentive type
  • Age: 18-65 år
  • Not medically treated for adhd symptoms, or medically treated with central stimulants or comparable substance since at least one month with no significant changes in dosage and where no change in medical treatment is anticipated during the study time frame for the participant.
  • Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
  • Participant has signed informed consent to the study.

Exclusion Criteria:

  • Diagnosed substance abuse according to DSM-IV criteria within 3 months prior to screening. Earlier episodic substance abuse is not excluding
  • Co-existing psychiatric condition that investigators believe will unable the participant to follow through the training protocol and take part in measures taken during the study time frame.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477125

Locations
Sweden
Centrum för Psykiatriforskning
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Director: Ylva Ginsberg, MD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Niklas Greback, Lic. Psychologist, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01477125     History of Changes
Other Study ID Numbers: X002
Study First Received: November 15, 2011
Last Updated: November 18, 2011
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Keywords provided by Karolinska Institutet:
adhd
working
memory
training
comt
snap25
d2
drd2

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013