NCT01663610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

August 9, 2012

Last Update Submit

May 15, 2014

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Change (from baseline) in ADHD symptoms

    6 weeks (Post) and 9 months (FU)

  • Change (from baseline) in dialy life function

    6 weeks (Post) and 9 months (FU)

  • Change (from baseline) in Depression and Anxiety

    6 weeks (Post) and 9 months (FU)

  • Change (from baseline) in perecived stress

    6 weeks (Post) and 9 months (FU)

Other Outcomes (1)

  • Treatment evaluation and usage

    Post-treatment (6 weeks)

Study Arms (2)

VardagsSMART

EXPERIMENTAL

VardagsSMART Internet-based course with therapist support during 6 weeks

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)

Interventions

VardagsSMARTBEHAVIORAL

VardagsSMART Internet-based course with therapist support during 6 weeks

VardagsSMART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stockholm, Stockholm County, 14186, Sweden

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Viktor Kaldo, Ph.D

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 13, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

SE(1)