ADHDVardagsSMARTNCT01663610
Online Course Teachning Adults With ADHD How to Use a Smartphone
A study testing VardagsSMART in people with ADHD, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD
- What is being tested?
- VardagsSMART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
Stockholm, Stockholm County, 14186
About this study
Official title: Online Course for Adults With ADHD or Subclinical ADHD Teaching How to Use a Smartphone as a Support in Their Everyday Life
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.
Read the detailed description
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.
- Conditions
- ADHD
- Being tested
- VardagsSMART
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VardagsSMARTBehavioural
VardagsSMART Internet-based course with therapist support during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| VardagsSMART | Experimental | VardagsSMART Internet-based course with therapist support during 6 weeks Receives: Behavioral: VardagsSMART |
| Wait List Control (CONT) | No intervention | Weekly registrations only. After 6 weeks the Internet-based course without therapist support well be offered (SelfSMART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) in symptoms of inattention and concentration
Adult Self Report Scale (ASRS), the subscale measuring inattention and concentration (item 1-4 and 7-11)
Measured: 6 weeks (Post) and 9 months (FU)
Secondary outcomes (4)
Change (from baseline) in ADHD symptoms
Adult Self Report Scale (ASRS), Full Scale
Measured: 6 weeks (Post) and 9 months (FU)
Change (from baseline) in dialy life function
Sheehan Disability Scale (SDS)
Measured: 6 weeks (Post) and 9 months (FU)
Change (from baseline) in Depression and Anxiety
Hospital Anxiety and Depression Scale (HADS)
Measured: 6 weeks (Post) and 9 months (FU)
Change (from baseline) in perecived stress
Perceived Stress Scale-4 (PSS-4)
Measured: 6 weeks (Post) and 9 months (FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktor Kaldo, Karolinska Institutet
- Investigators
- Viktor Kaldo, Ph.D, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663610
- Sponsor's protocol ID
- 2012334314
- Acronym
- VardagsSMART
- Status last verified
- May 2014
- First submitted
- 9 Aug 2012
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Course for Adults With ADHD or Subclinical ADHD Teaching How to Use a Smartphone as a Support in Their Everyday Life
- ClinicalTrials.gov ID
- NCT01663610
- Acronym / sponsor ID
- VardagsSMART / 2012334314
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VardagsSMART | Experimental | Behavioral: VardagsSMARTVardagsSMART Internet-based course with therapist support during 6 weeks |
| Wait List Control (CONT) | No intervention | –Weekly registrations only. After 6 weeks the Internet-based course without therapist support well be offered (SelfSMART) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VardagsSMARTVardagsSMART Internet-based course with therapist support during 6 weeks | Behavioural | VardagsSMART |
Primary outcome
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)
4 secondary outcomes
Change (from baseline) in ADHD symptoms
Time frame: 6 weeks (Post) and 9 months (FU)
Change (from baseline) in dialy life function
Time frame: 6 weeks (Post) and 9 months (FU)
Change (from baseline) in Depression and Anxiety
Time frame: 6 weeks (Post) and 9 months (FU)
Change (from baseline) in perecived stress
Time frame: 6 weeks (Post) and 9 months (FU)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Kaldo, Ph.D principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VardagsSMART in people with ADHD, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (from baseline) in symptoms of inattention and concentration (time frame: 6 weeks (Post) and 9 months (FU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.