Clinical trial NCT04726813: An Internet-delivered Intervention for Coping With ADHD in Adulthood
Official title: An Internet-delivered Intervention for Coping With ADHD in Adulthood - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
RCT
Internet-delivered intervention
Self-help
Coping
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2021-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes.

Detailed description: ADHD in adulthood, with an estimated prevalence of 2 - 3 %, is associated with challenges in daily life functioning. The availability of evidence-based psychological interventions for adults with ADHD is poor. Interventions delivered over the Internet might help to increase the availability of effective psychological interventions for this group. The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes. A minimum of 118 participants with a self-reported ADHD diagnosis will be included in the study. In phase 1 we will conduct a randomized controlled trial with two arms, 1) self-guided Internet-delivered intervention for coping with ADHD (N=59), 2) self-guided online psychoeducation (control group, N= 59), with a 3 month follow-up. After 3 months the second phase of the study starts. In this phase (II) the control group participants will receive an adaptive version of the Internet-delivered intervention. This includes adaptation of the order of the modules to the individual participant needs, with the use of rule-based and machine-learning based adaptation. Clinical outcomes in both phases are inattention, hyperactivity, quality of life and stress. Uptake, usage, adherence and satisfaction will be explored. Repeated measurers are at baseline, weekly during the intervention period, post-intervention and 3 months follow-up.

Eligibility criteria: Inclusion Criteria:

1. Adults with a self-reported diagnosis of ADHD (date, venue and diagnosing physician)
2. Access to and ability to use a computer, smartphone and the Internet.
3. Current problems with organizing daily activity and 17 points of more on at least one of the ASRS subscales
4. Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
5. Speaks, writes and reads Norwegian

   Exclusion Criteria:
6. Current self-reported diagnosis of severe psychiatric illness such as borderline or antisocial personality disorder, bipolar disorder, ongoing substance abuse, and/or suicidal ideation assessed with item 9 on the MADRS
7. Participants who are taking prescribed ADHD medication have to be stable on the medication at least four weeks before the study and during the study.

Primary outcomes:
measure: The Adult ADHD Self-Rating Scale (ASRS)
timeFrame: Change in ADHD symptoms at 8 weeks
measure: Adult ADHD Quality of Life Measure (AAQol)
timeFrame: Change in quality of life at 8 weeks
Secondary outcomes:
measure: The perceived stress scale (PSS)
timeFrame: Change in stress symptoms at 8 weeks
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change in depression symptoms at 8 weeks
Other outcomes:
measure: Adherence
timeFrame: immediately after the intervention
measure: User satisfaction
timeFrame: immediately after the intervention
Locations:
city: Bergen
country: Norway
facility: Clinical Psychology
state: Vestland
Study officials:
References:
citation: Kenter RMF, Lundervold AJ, Nordgreen T. A self-guided Internet-delivered intervention for adults with ADHD: a protocol for a randomized controlled trial. Internet Interv. 2021 Nov 20;26:100485. doi: 10.1016/j.invent.2021.100485. eCollection 2021 Dec.