Online Course Teachning Adults With ADHD How to Use a Smartphone

ADHD Clinical Trial

— VardagsSMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663610
• Other study ID #: 2012334314
• Status: Completed
• Phase: N/A
• First received: August 9, 2012
• Last updated: May 15, 2014
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• VardagsSMART
VardagsSMART Internet-based course with therapist support during 6 weeks

Locations

Country	Name	City	State
Sweden	Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment evaluation and usage	Questions on treatment satisfaction, adherence, and precevied usefullness of treatment.	Post-treatment (6 weeks)	No
Primary	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)	6 weeks (Post) and 9 months (FU)	No
Secondary	Change (from baseline) in ADHD symptoms	Adult Self Report Scale (ASRS), Full Scale	6 weeks (Post) and 9 months (FU)	No
Secondary	Change (from baseline) in dialy life function	Sheehan Disability Scale (SDS)	6 weeks (Post) and 9 months (FU)	No
Secondary	Change (from baseline) in Depression and Anxiety	Hospital Anxiety and Depression Scale (HADS)	6 weeks (Post) and 9 months (FU)	No
Secondary	Change (from baseline) in perecived stress	Perceived Stress Scale-4 (PSS-4)	6 weeks (Post) and 9 months (FU)	No