An Internet-delivered Intervention for Coping With ADHD in Adulthood (MyADHD)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
MyADHD
Psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for ADHD focused on measuring ADHD, RCT, Internet-delivered intervention, Self-help, Coping
Eligibility Criteria
Inclusion Criteria:
- Adults with a self-reported diagnosis of ADHD (date, venue and diagnosing physician)
- Access to and ability to use a computer, smartphone and the Internet.
- Current problems with organizing daily activity and 17 points of more on at least one of the ASRS subscales
- Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
Speaks, writes and reads Norwegian
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Clinical Psychology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
a self-guided Internet delivered intervention
Psycho-education
Arm Description
MinADHD: 7 self-help modules.
One self-guided psychoeducation module
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
The perceived stress scale (PSS)
The Perceived Stress Scale (PSS) is a widely used psychological instrument for measuring stress.
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
Full Information
NCT ID
NCT04726813
First Posted
January 8, 2021
Last Updated
June 14, 2022
Sponsor
University of Bergen
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT04726813
Brief Title
An Internet-delivered Intervention for Coping With ADHD in Adulthood
Acronym
MyADHD
Official Title
An Internet-delivered Intervention for Coping With ADHD in Adulthood - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
October 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
The Research Council of Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, RCT, Internet-delivered intervention, Self-help, Coping
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a self-guided Internet delivered intervention
Arm Type
Experimental
Arm Description
MinADHD: 7 self-help modules.
Arm Title
Psycho-education
Arm Type
Placebo Comparator
Arm Description
One self-guided psychoeducation module
Intervention Type
Behavioral
Intervention Name(s)
MyADHD
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Adult ADHD Self-Rating Scale (ASRS)
Description
The Adult ADHD Self-Rating Scale (ASRS) includes all the 18 symptoms of ADHD included in the diagnostic manual (DSM-5).
Time Frame
Change in ADHD symptoms at 8 weeks
Title
Adult ADHD Quality of Life Measure (AAQol)
Description
The AAQoL has 29 items designed to assess HRQL during the past two weeks among adults with ADHD.
Time Frame
Change in quality of life at 8 weeks
Secondary Outcome Measure Information:
Title
The perceived stress scale (PSS)
Description
The Perceived Stress Scale (PSS) is a widely used psychological instrument for measuring stress.
Time Frame
Change in stress symptoms at 8 weeks
Title
The Patient Health Questionnaire-9 (PHQ-9)
Description
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
Time Frame
Change in depression symptoms at 8 weeks
Other Pre-specified Outcome Measures:
Title
Adherence
Description
Usage outcomes of interest are attrition and adherence to the intervention.
Time Frame
immediately after the intervention
Title
User satisfaction
Description
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
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with a self-reported diagnosis of ADHD (date, venue and diagnosing physician)
Access to and ability to use a computer, smartphone and the Internet.
Current problems with organizing daily activity and 17 points of more on at least one of the ASRS subscales
Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
Speaks, writes and reads Norwegian
Exclusion Criteria:
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
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.
Facility Information:
Facility Name
Clinical Psychology
City
Bergen
State/Province
Vestland
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34877262
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.
Results Reference
derived
Learn more about this trial
An Internet-delivered Intervention for Coping With ADHD in Adulthood
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