NCT02041884

Brief Summary

The purpose of this study is to further evaluate the treatment for adults with ADHD used in our previous study (clinicaltrials.gov ID NCT01659164). It will now be converted to therapist supported, internet-delivered cognitive behavioral therapy (iCBT) with an additional smartphone application and evaluated through a randomized controlled trial during 12 weeks. The patients will be randomized to one of three conditions

  • an active treatment group where the intervention is based on cognitive - and dialectical behavioral therapy (CBT and DBT) and the mobile app.
  • an active ICBT-treatment based on psychoeducation, a CBT stress-reduction program and Applied Relaxation, and
  • treatment as usual (TAU) / waiting list. The main objective of the study is to evaluate if both of the treatment conditions will show better outcomes than TAU regarding decreased ADHD symptoms and increased functioning and life quality. Another objective is to evaluate if the group receiving the active iCBT treatment (based on CBT and DBT) will show better outcomes in comparison to the control group regarding ADHD symptoms, overall functioning and life quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

January 17, 2014

Last Update Submit

January 5, 2020

Conditions

ADHD

Keywords

Cognitive Behavioral TherapyDialectical Behavioral TherapyApplied RelaxationStress-reductionSmartphone applicationADHDRandomized controlled trialPsychological treatmentEfficacy

Outcome Measures

Primary Outcomes (1)

  • Change (from baseline) in ASRS- v 1.1

    ADHD Self Report Scale (ASRS) (self rating)

    Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)

Secondary Outcomes (11)

  • Change (from baseline) in ADHD Rating Scale

    Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)

  • Change (from baseline) in EQ-5D

    Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)

  • Change (from baseline) in ISI

    Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)

  • Change (from baseline) in PSS-4

    Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)

  • Change (from baseline) in SDS

    Baseline, 12 weeks (post), 24 weeks (FU3), and after 60 weeks (FU12)

  • +6 more secondary outcomes

Other Outcomes (4)

  • Treatment evaluation

    during treatment and after 12 weeks of treatment (post)

  • CGI-I

    12 weeks (post) and after 3 and 12 months (post)

  • TCS

    Filled out by the patient at the 1st and 5th week of treatment

  • +1 more other outcomes

Study Arms (3)

iCBT

EXPERIMENTAL

A skill training internet-based treatment program based on CBT and DBT interventions .

Behavioral: iCBT for Adults with ADHD

Internet stress-reduction

ACTIVE COMPARATOR

Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group)

Behavioral: Internet stress-reduction

Treatment as usual (TAU)/waiting list

OTHER

Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24)

Other: Treatment as usual (TAU)/waiting list

Interventions

iCBT for Adults with ADHDBEHAVIORAL

A skill training internet-based treatment program based on CBT and DBT interventions .

iCBT
Internet stress-reductionBEHAVIORAL

Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group)

Internet stress-reduction
Treatment as usual (TAU)/waiting listOTHER

Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24)

Treatment as usual (TAU)/waiting list

Eligibility Criteria

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

You may qualify if:

  • Swedish citizen
  • Clinical diagnosis of AD/HD according to DSM-IV or DSM-5
  • Age 18-65
  • or more on the Adult ADHD Self Report Scale (ASRS v1.1)
  • Not medically treated for adhd symptoms, or medically treated with central stimulants or comparable substance since at least one month with no significant changes in dosage and where no change in medical treatment is anticipated during the study time frame for the participant. No change in any other medical treatment is anticipated during the study time frame for the participant.
  • Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
  • The participant hasn´t used drugs the last 3 months
  • Access to, and ability to use the Internet and mobile phone during the study time
  • ability to understand Swedish in speech and writing

You may not qualify if:

  • Diagnosed substance abuse according to DSM-IV or DSM-5 criteria within 3 months prior to screening. Earlier episodic substance abuse is not excluding
  • Co-existing psychiatric condition that investigators believe will unable the participant to follow through the training protocol and take part in measures taken during the study time frame.
  • IQ ≤85 according to a neuropsychological assessment
  • Suicidality risk which is assessed during the first assessment interview.
  • Organic brain syndrome
  • Serious somatic condition which will unable the participant to participate (through the training protocol)or, is anticipated to have a negative impact on the treatment results
  • Autism spectrum disorder where the function level is deemed too low for the treatment to be carried out which is defined as moderate or severe problems scale (level 2 and 3) according to DSM-5
  • Severe depression defined by \>34 p on MADRS-S or by a clinician´s assessment
  • Other current psychological treatment for AD/HD or previous participation in such a treatment that is deemed to interfere with the study design
  • severe writing and reading disabilities
  • dyslexia of such degree that it impedes participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internetpsykiatrienheten, Psykiatri Sydväst, SLSO

Stockholm, Sweden

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Viktor Kaldo, PhD/Ass prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 22, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

SE(1)