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Completed

NCT Number: NCT01663610

Online Course Teachning Adults With ADHD How to Use a Smartphone

This study is a randomized controlled trial (RCT) to evaluate the effect of an internet-based, guided self-help course for individuals who have recivied an ADHD diagnsis or struggle with organizing daily life and/or easily get distracted. The course (vardagsSMART) teach the participants how to use a Smartphone to better organize their everday life and will be compared to a wait list control group (CONT) that later will recieve the same course without guidance from a supervisor(selfSMART). It is hypothesized that VardagsSMART will be superior to CONT on ability to organize everyday life and ADHD-symptoms, and that vardagsSMART will be superior to selfSMART on adherence, understanding and perecived usefullness.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden

Stockholm, Stockholm County, 14186, Sweden

About this study

Smartphones have a potential to improve the life of individuals who have major problems with structure and remembrance of everyday tasks. The automation by smartphones of these tasks away from caregivers to the individual is a process that is both time saving and positive for the individuals sense of autonomy.

There is too little research to date to say with clarity that smartphones is this tool for most of the patient group but many patients with ADHD report that a smartphone system for organisation and remembrance is a key that helps many live a more meaningful life.

The best way to teach these skills has not yet been proven. There is a clear advantage with teaching courses concerning IT in an online setting since hyperlinks and other texts can be easily forwarded and the course participants can easily use premade calendars and other tools. This research will try to determine if this type of online course is helpful for these patients.

VardagsSMART is an online course which will be compared to a waiting list controll group (CONT) which weekly records how they manage their ADHD symptoms.

The main purpose of this study is to examine whether the VardagsSMART course have a positive effect for the patient group. An untreated control group is used to ensure that the effects are not only due to spontaneous improvement. The control group will afterwards be offered the course without therapist support (SelfSMART), in order to make a preliminary evaluation of the importance of therapist support.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • have problems organizing daily activity measured by more then 17 points on the ASRS questionaire item 1-4 and 7-11-
  • has acces to a smartphone (android or iphone) with internet acces.
  • at least 18 years
  • speaks, writes and read Swedish
  • can not foresee any practical barriers to participation.

Exclusion criteria

  • has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview.
  • somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders).
  • have severe depression, defined as MADRS-S over 30 or suicidal risk judged by more than 4 points on the MADRS-S question 9 or according to the structured telephone assessment.
  • currently undergoing some form of treatment that focuses on reducing symptoms of ADHD.

Treatment and study plan

VardagsSMART

Behavioral

VardagsSMART Internet-based course with therapist support during 6 weeks

Primary outcomes

  1. Change (from baseline) in symptoms of inattention and concentration

    Time frame: 6 weeks (Post) and 9 months (FU)

    Adult Self Report Scale (ASRS), the subscale measuring inattention and concentration (item 1-4 and 7-11)

Secondary outcomes

  1. Change (from baseline) in ADHD symptoms

    Time frame: 6 weeks (Post) and 9 months (FU)

    Adult Self Report Scale (ASRS), Full Scale

  2. Change (from baseline) in dialy life function

    Time frame: 6 weeks (Post) and 9 months (FU)

    Sheehan Disability Scale (SDS)

  3. Change (from baseline) in Depression and Anxiety

    Time frame: 6 weeks (Post) and 9 months (FU)

    Hospital Anxiety and Depression Scale (HADS)

  4. Change (from baseline) in perecived stress

    Time frame: 6 weeks (Post) and 9 months (FU)

    Perceived Stress Scale-4 (PSS-4)

Other outcomes

  1. Treatment evaluation and usage

    Time frame: Post-treatment (6 weeks)

    Questions on treatment satisfaction, adherence, and precevied usefullness of treatment.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Online Course for Adults With ADHD or Subclinical ADHD Teaching How to Use a Smartphone as a Support in Their Everyday Life

Acronym: VardagsSMART

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2012
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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