An Internet-delivered Intervention for Coping With ADHD in Adulthood

ADHD Clinical Trial

— MyADHD  

Official title:

An Internet-delivered Intervention for Coping With ADHD in Adulthood - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726813
• Other study ID #: 203804
• Status: Completed
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: June 2022
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• MyADHD
The main goals of the intervention are to help participants with better functioning in daily life; offer strategies that will lead to stress reduction and reduce inattention and improve quality of life.The intervention includes: a short introductory chapter (open to everyone), followed by a start module (goal setting), followed by 6 different themed optional modules. Module content is based on GMT, DBT and CBT techniques and is tailored towards key concerns and difficulties experienced adults with ADHD as informed by previous research (focus-groups, lived experience groups) and experiences from group GMT and DBT.
• Psychoeducation
Participants in the control condition will be assigned to psychoeducation modules (see Table 2) and will receive restricted access to the platform. They can contact or be contacted if their symptoms levels increases.

Locations

Country	Name	City	State
Norway	Clinical Psychology	Bergen	Vestland

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence	Usage outcomes of interest are attrition and adherence to the intervention.	immediately after the intervention
Other	User satisfaction	Four open end questions at the end of the modules: Were there parts of the module that you experienced as helpful and/or supportive?; Were there parts of the module that you experienced as complicated and/or unhelpful?; Would you recommend this module to a friend or a family member with similar difficulties as yourself?; How useful did you find this module? 1-10	immediately after the intervention
Primary	The Adult ADHD Self-Rating Scale (ASRS)	The Adult ADHD Self-Rating Scale (ASRS) includes all the 18 symptoms of ADHD included in the diagnostic manual (DSM-5).	Change in ADHD symptoms at 8 weeks
Primary	Adult ADHD Quality of Life Measure (AAQol)	The AAQoL has 29 items designed to assess HRQL during the past two weeks among adults with ADHD.	Change in quality of life at 8 weeks
Secondary	The perceived stress scale (PSS)	The Perceived Stress Scale (PSS) is a widely used psychological instrument for measuring stress.	Change in stress symptoms at 8 weeks
Secondary	The Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9: Kroenke et al., 2001) is a self-report tool used to assess the presence and severity of depressive symptoms	Change in depression symptoms at 8 weeks