Online Course Teachning Adults With ADHD How to Use a Smartphone (VardagsSMART)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
VardagsSMART
Sponsored by
About this trial
This is an interventional treatment trial for ADHD
Eligibility Criteria
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.
Sites / Locations
- Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
VardagsSMART
Wait List Control (CONT)
Arm Description
VardagsSMART Internet-based course with therapist support during 6 weeks
Weekly registrations only. After 6 weeks the Internet-based course without therapist support well be offered (SelfSMART)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change (from baseline) in ADHD symptoms
Adult Self Report Scale (ASRS), Full Scale
Change (from baseline) in dialy life function
Sheehan Disability Scale (SDS)
Change (from baseline) in Depression and Anxiety
Hospital Anxiety and Depression Scale (HADS)
Change (from baseline) in perecived stress
Perceived Stress Scale-4 (PSS-4)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01663610
Brief Title
Online Course Teachning Adults With ADHD How to Use a Smartphone
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VardagsSMART
Arm Type
Experimental
Arm Description
VardagsSMART Internet-based course with therapist support during 6 weeks
Arm Title
Wait List Control (CONT)
Arm Type
No Intervention
Arm Description
Weekly registrations only. After 6 weeks the Internet-based course without therapist support well be offered (SelfSMART)
Intervention Type
Behavioral
Intervention Name(s)
VardagsSMART
Intervention Description
VardagsSMART Internet-based course with therapist support during 6 weeks
Primary Outcome Measure Information:
Title
Change (from baseline) in symptoms of inattention and concentration
Description
Adult Self Report Scale (ASRS), the subscale measuring inattention and concentration (item 1-4 and 7-11)
Time Frame
6 weeks (Post) and 9 months (FU)
Secondary Outcome Measure Information:
Title
Change (from baseline) in ADHD symptoms
Description
Adult Self Report Scale (ASRS), Full Scale
Time Frame
6 weeks (Post) and 9 months (FU)
Title
Change (from baseline) in dialy life function
Description
Sheehan Disability Scale (SDS)
Time Frame
6 weeks (Post) and 9 months (FU)
Title
Change (from baseline) in Depression and Anxiety
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
6 weeks (Post) and 9 months (FU)
Title
Change (from baseline) in perecived stress
Description
Perceived Stress Scale-4 (PSS-4)
Time Frame
6 weeks (Post) and 9 months (FU)
Other Pre-specified Outcome Measures:
Title
Treatment evaluation and usage
Description
Questions on treatment satisfaction, adherence, and precevied usefullness of treatment.
Time Frame
Post-treatment (6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktor Kaldo, Ph.D
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
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Online Course Teachning Adults With ADHD How to Use a Smartphone
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