ADHDNCT05700539
Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
A study testing Internet-based cognitive behavioral therapy in people with ADHD, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Internet-based cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder in Sweden
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.
- Conditions
- ADHD
- Being tested
- Internet-based cognitive behavioral therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioral therapyBehavioural
A ten-week treatment based on cognitive behavioral therapy for ADHD, including two mandatory modules and at least four self-selected modules (out of ten available modules). The treatment consists of reading material and exercises to be completed each week.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive behavioral therapy | Experimental | Not described Receives: Behavioral: Internet-based cognitive behavioral therapy |
| Wait-list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
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.
Measured: Change in quality of life from baseline to 10 week (i.e., post-treatment)
Adult Attention-deficit/hyperactivity disorder Quality-of-Life scale (AAQoL)
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.
Measured: Change in quality of life from baseline six-month follow-up
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
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.
Measured: Change in ADHD symptoms from baseline to 10 week (i.e., post-treatment)
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) Symptoms Checklist (ASRS)
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.
Measured: Change in ADHD symptoms from baseline to six-month follow-up
Secondary outcomes (7)
Generalized Anxiety Disorder - 7 Items (GAD-7)
The GAD-7 is an instrument that measures anxiety (Spitzer, Kroenke, Williams, \& Löwe, 2006). Its internal consistency is excellent (Cronbach's α = .92), and it has good test-retest reliability (IntraClass Correlation = .83; Spitzer et al., 2006). The instrument includes seven items and has a single-factor solution. The score ranges from 0 to 21 points and the items range from 0 ("Not at all") to 3 ("Nearly every day"; Spitzer et al., 2006). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Feeling nervous, anxious, or on edge."
Measured: Change in anxiety symptoms from baseline to 10 week (i.e., post-treatment)
Generalized Anxiety Disorder - 7 Items (GAD-7)
The GAD-7 is an instrument that measures anxiety (Spitzer, Kroenke, Williams, \& Löwe, 2006). Its internal consistency is excellent (Cronbach's α = .92), and it has good test-retest reliability (IntraClass Correlation = .83; Spitzer et al., 2006). The instrument includes seven items and has a single-factor solution. The score ranges from 0 to 21 points and the items range from 0 ("Not at all") to 3 ("Nearly every day"; Spitzer et al., 2006). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Feeling nervous, anxious, or on edge."
Measured: Change in anxiety symptoms from baseline to six-month follow-up
Patient Health Questionnaire - 9 Items (PHQ-9)
The PHQ-9 is a nine-item instrument measuring depression. It has excellent internal consistency (Cronbach's α = .89) and a good test-retest correlation (r = .84; Kroenke et al., 2001). The instrument has a single-factor solution. The score ranges from 0 to 27 points (Kroenke, Spitzer, \& Williams, 2001). Items range from 0 ("Not at all") to 3 ("Nearly every day"). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Little interest or pleasure in doing things."
Measured: Change in depressive symptoms from baseline to 10 week (i.e., post-treatment)
Patient Health Questionnaire - 9 Items (PHQ-9)
The PHQ-9 is a nine-item instrument measuring depression. It has excellent internal consistency (Cronbach's α = .89) and a good test-retest correlation (r = .84; Kroenke et al., 2001). The instrument has a single-factor solution. The score ranges from 0 to 27 points (Kroenke, Spitzer, \& Williams, 2001). Items range from 0 ("Not at all") to 3 ("Nearly every day"). One example of an item is: "Over the last 2 weeks, how often have you been bothered by any of the following problems? Little interest or pleasure in doing things."
Measured: Change in depressive symptoms from baseline to six-month follow-up
Perceived Stress scale (PSS)
The PSS is an instrument that evaluates the subjective experience of general stress in various situations and is scored on a five-point Likert-scale 0-4 ("Never" to "Very often"), with seven items being scored in reverse (items 4-7, 9-10, and 13). The PSS includes 14 items in total and has been shown to have good internal consistency (Cronbach's α = .84-.86) as well as good convergent and discriminant validity (Cohen, Kamarck, \& Mermelstein, 1983).
Measured: Change in stress symptoms from baseline to 10 week (i.e., post-treatment)
Perceived Stress scale (PSS)
The PSS is an instrument that evaluates the subjective experience of general stress in various situations and is scored on a five-point Likert-scale 0-4 ("Never" to "Very often"), with seven items being scored in reverse (items 4-7, 9-10, and 13). The PSS includes 14 items in total and has been shown to have good internal consistency (Cronbach's α = .84-.86) as well as good convergent and discriminant validity (Cohen, Kamarck, \& Mermelstein, 1983).
Measured: Change in stress symptoms from baseline to six-month follow-up
Negative Effects Questionnaire (NEQ)
The NEQ is a 32-item instrument that assesses unwanted and adverse events experienced by patients undergoing psychotherapy (Rozental, Kottorp, Boettcher, Andersson, \& Carlbring, 2016; Rozental et al., 2019), e.g., "I experienced more unpleasant feelings". It is comprised of six factors: symptoms, quality, dependency, stigma, hopelessness, and failure. The internal consistency for the full instrument is excellent (Cronbach's α = .95), and is scored on several dimensions; 1) "Did you experience this?" (yes/no), 2) "If yes - here is how negatively it affected me", from 0 ("Not at all") to 4 ("Extremely"), and 3) "Probably caused by" ("The treatment I received" or "Other circumstances").
Measured: Incidence of negative effects of psychological treatment from baseline to post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start25 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Alexander Rozental, Karolinska Institutet
- Investigators
- David Forsström, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700539
- Sponsor's protocol ID
- DF0001
- Status last verified
- Aug 2026
- First submitted
- 21 Dec 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder in Sweden
- ClinicalTrials.gov ID
- NCT05700539
- Acronym / sponsor ID
- DF0001
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavioral therapy | Experimental | Behavioral: Internet-based cognitive behavioral therapy |
| Wait-list control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive behavioral therapyA ten-week treatment based on cognitive behavioral therapy for ADHD, including two mandatory modules and at least four self-selected modules (out of ten available modules). The treatment consists of reading material and exercises to be completed each week. | Behavioural | Internet-based cognitive behavioral therapy |
Primary outcome
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 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 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.
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.
7 secondary outcomes
Generalized Anxiety Disorder - 7 Items (GAD-7)
Time frame: Change in anxiety symptoms from baseline to 10 week (i.e., post-treatment)
Generalized Anxiety Disorder - 7 Items (GAD-7)
Time frame: Change in anxiety symptoms from baseline to six-month follow-up
Patient Health Questionnaire - 9 Items (PHQ-9)
Time frame: Change in depressive symptoms from baseline to 10 week (i.e., post-treatment)
Patient Health Questionnaire - 9 Items (PHQ-9)
Time frame: Change in depressive symptoms from baseline to six-month follow-up
Perceived Stress scale (PSS)
Time frame: Change in stress symptoms from baseline to 10 week (i.e., post-treatment)
Perceived Stress scale (PSS)
Time frame: Change in stress symptoms from baseline to six-month follow-up
Negative Effects Questionnaire (NEQ)
Time frame: Incidence of negative effects of psychological treatment from baseline to post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Forsström, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavioral therapy in people with ADHD, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.