A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder in Sweden
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Over 18 years old of age.
- •Can read and write in Swedish.
- •Have access to a computer, tablet, or smartphone with an Internet connection.
- •Have previously been diagnosed with ADHD.
- •Are studying at a university or college in Sweden or working at least 50% of a full time-employment.
Exclusion Criteria
- •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.
- •Has started or changed their medication for any psychiatric diagnosis in the last three months.
- •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).
Arms & Interventions
Wait-list control
Internet-based cognitive behavioral therapy
Intervention: Internet-based cognitive behavioral therapy (Behavioral)
Outcomes
Primary Outcomes
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
Time Frame: Change in ADHD symptoms from baseline to six-month follow-up
The ASRS is an instrument that measures ADHD-symptoms (Kessler et al., 2005). The instrument consists of 18 items that correspond to the 18 symptom-criteria for ADHD found in the DSM-IV-TR (Association, 2000). Of these 18 questions, six have been identified as most predictive of ADHD-symptoms. The overall range of the entire measure is 0 to 72. However, there are separate items focusing on attention and hyperactivity.
Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
Time Frame: Change in quality of life from baseline six-month follow-up
The AAQoL (Brod et al., 2015; Brod, Johnston, Able, \& Swindle, 2006) is a disease-specific quality of life measure for adults with ADHD. The instrument measures quality of life-consequences of ADHD in four domains using and consists of 29 items. The instrument has excellent internal consistency (Cronbach's α = .93 for the overall measure). One example of an item is "In the last two weeks, how hard has it been for you to remember important things?", scored on a five-point Likert-like scale from "Not at all/Never" (1) to "Extremely/Very Often" (5). The scale ranges from 0 to 145.
Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
Time Frame: Change in quality of life from baseline to 10 week (i.e., post-treatment)
The AAQoL (Brod et al., 2015; Brod, Johnston, Able, \& Swindle, 2006) is a disease-specific quality of life measure for adults with ADHD. The instrument measures quality of life-consequences of ADHD in four domains using and consists of 29 items. The instrument has excellent internal consistency (Cronbach's α = .93 for the overall measure). One example of an item is "In the last two weeks, how hard has it been for you to remember important things?", scored on a five-point Likert-like scale from "Not at all/Never" (1) to "Extremely/Very Often" (5). The scale ranges from 0 to 145.
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
Time Frame: Change in ADHD symptoms from baseline to 10 week (i.e., post-treatment)
The ASRS is an instrument that measures ADHD-symptoms (Kessler et al., 2005). The instrument consists of 18 items that correspond to the 18 symptom-criteria for ADHD found in the DSM-IV-TR (Association, 2000). Of these 18 questions, six have been identified as most predictive of ADHD-symptoms. The overall range of the entire measure is 0 to 72. However, there are separate items focusing on attention and hyperactivity.
Secondary Outcomes
- Perceived Stress scale (PSS)(Change in stress symptoms from baseline to six-month follow-up)
- Negative Effects Questionnaire (NEQ)(Incidence of negative effects of psychological treatment from baseline to post-treatment)
- Generalized Anxiety Disorder - 7 Items (GAD-7)(Change in anxiety symptoms from baseline to six-month follow-up)
- Patient Health Questionnaire - 9 Items (PHQ-9)(Change in depressive symptoms from baseline to six-month follow-up)
- Generalized Anxiety Disorder - 7 Items (GAD-7)(Change in anxiety symptoms from baseline to 10 week (i.e., post-treatment))
- Patient Health Questionnaire - 9 Items (PHQ-9)(Change in depressive symptoms from baseline to 10 week (i.e., post-treatment))
- Perceived Stress scale (PSS)(Change in stress symptoms from baseline to 10 week (i.e., post-treatment))
Investigators
Alexander Rozental
Principal Investigator
Karolinska Institutet