Online Course Teachning Adults With ADHD How to Use a Smartphone (VardagsSMART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Viktor Kaldo, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01663610
First received: August 9, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
ADHD
Behavioral: VardagsSMART

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Online Course for Adults With ADHD or Subclinical ADHD Teaching How to Use a Smartphone as a Support in Their Everyday Life

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change (from baseline) in symptoms of inattention and concentration [ Time Frame: 6 weeks (Post) and 9 months (FU) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks (Post) and 9 months (FU) ] [ Designated as safety issue: No ]
    Adult Self Report Scale (ASRS), Full Scale

  • Change (from baseline) in dialy life function [ Time Frame: 6 weeks (Post) and 9 months (FU) ] [ Designated as safety issue: No ]
    Sheehan Disability Scale (SDS)

  • Change (from baseline) in Depression and Anxiety [ Time Frame: 6 weeks (Post) and 9 months (FU) ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS)

  • Change (from baseline) in perecived stress [ Time Frame: 6 weeks (Post) and 9 months (FU) ] [ Designated as safety issue: No ]
    Perceived Stress Scale-4 (PSS-4)


Other Outcome Measures:
  • Treatment evaluation and usage [ Time Frame: Post-treatment (6 weeks) ] [ Designated as safety issue: No ]
    Questions on treatment satisfaction, adherence, and precevied usefullness of treatment.


Enrollment: 58
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VardagsSMART
VardagsSMART Internet-based course with therapist support during 6 weeks
Behavioral: VardagsSMART
VardagsSMART Internet-based course with therapist support during 6 weeks
No Intervention: Wait List Control (CONT)
Weekly registrations only. After 6 weeks the Internet-based course without therapist support well be offered (SelfSMART)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663610

Locations
Sweden
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Viktor Kaldo, Ph.D Karolinska Institutet
  More Information

No publications provided

Responsible Party: Viktor Kaldo, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01663610     History of Changes
Other Study ID Numbers: 2012334314
Study First Received: August 9, 2012
Last Updated: May 15, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014