Clinical trial NCT05700539: Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
Official title: A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder in Sweden
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2023-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Attention deficit hyperactivity disorder (ADHD) is a disorder characterized by lack of attention, hyperactivity, and impulsivity. It can have major impact on everyday life and result in negative consequences for one's personal, academic, and work situation. For individuals with symptoms of ADHD, increased levels of anxiety and depression are common, and an overall reduction of quality of life is often present. This study protocol describes a clinical trial of internet-based cognitive behavioral therapy (iCBT), using a randomized controlled study design, with the primary aim to increase quality of life, as well as to reduce symptoms of ADHD, anxiety, depression, and stress. A second aim is to investigate, by qualitative means, what aspects of treatment were perceived as helpful and hindering when it comes to completing iCBT. Two hundred participants with symptoms of ADHD will be included and randomized to two conditions (treatment and wait-list control). The treatment period is comprised of ten weeks, with two mandatory modules and ten modules from which the participants can choose freely. Self-report measures are completed by the participants at baseline and end of treatment, as well as at a six-month follow-up. The treatment is guided by therapists and consists of weekly correspondence with the participants. The study will utilize an intention to treat design, with ANOVAs and Reliable Change Index to evaluate treatment effects. The qualitative part of the project will be interview-based and employ thematic analysis. Lastly, a psychometric evaluation of a common instrument for determining ADHD-symptoms will also be made. The results will hopefully contribute to the evidence base for iCBT for individuals with symptoms of ADHD and help disseminate potentially effective interventions.


Eligibility criteria: Inclusion Criteria:

1. Over 18 years old of age.
2. Can read and write in Swedish.
3. Have access to a computer, tablet, or smartphone with an Internet connection.
4. Have previously been diagnosed with ADHD.
5. Are studying at a university or college in Sweden or working at least 50% of a full time-employment.

Exclusion Criteria:

1. Shows elevated symptoms of depression or risk of suicide, i.e., a total score on the Patient Health Questionnaire - 9 items (PHQ-9; Kroenke, K., Spitzer, R. L., \& Williams, J. B. (2001)), \> 15 points, or scores \> 2 points on question i) concerning suicidality.
2. Has started or changed their medication for any psychiatric diagnosis in the last three months.
3. Exhibits another form of psychiatric diagnosis that requires more specialized care, for example substance abuse syndrome, anorexia nervosa, bipolar disorder, psychotic symptoms, or schizophrenia, as assessed with the MINI (Sheehan et al., 1998).

Primary outcomes:
measure: Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
timeFrame: Change in quality of life from baseline to 10 week (i.e., post-treatment)
measure: Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
timeFrame: Change in quality of life from baseline six-month follow-up
measure: Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
timeFrame: Change in ADHD symptoms from baseline to 10 week (i.e., post-treatment)
measure: Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
timeFrame: Change in ADHD symptoms from baseline to six-month follow-up
Secondary outcomes:
measure: Generalized Anxiety Disorder - 7 Items (GAD-7)
timeFrame: Change in anxiety symptoms from baseline to 10 week (i.e., post-treatment)
measure: Generalized Anxiety Disorder - 7 Items (GAD-7)
timeFrame: Change in anxiety symptoms from baseline to six-month follow-up
measure: Patient Health Questionnaire - 9 Items (PHQ-9)
timeFrame: Change in depressive symptoms from baseline to 10 week (i.e., post-treatment)
measure: Patient Health Questionnaire - 9 Items (PHQ-9)
timeFrame: Change in depressive symptoms from baseline to six-month follow-up
measure: Perceived Stress scale (PSS)
timeFrame: Change in stress symptoms from baseline to 10 week (i.e., post-treatment)
measure: Perceived Stress scale (PSS)
timeFrame: Change in stress symptoms from baseline to six-month follow-up
measure: Negative Effects Questionnaire (NEQ)
timeFrame: Incidence of negative effects of psychological treatment from baseline to post-treatment
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: David Forsström, PhD
role: PRINCIPAL_INVESTIGATOR
References: