ADHD Predominantly Inattentive TypeNCT04090983
Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation
A study testing Cognitive-behavioral therapy (Hesslinger protocol) and Cognitive-behavioral therapy (CADDI protocol) in people with ADHD Predominantly Inattentive Type, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Using a randomized controlled design, standard treatment of group cognitive-behavioral therapy (CBT) according to the Hesslinger protocol is compared to a newly developed group treatment specifically designed for adult patients with ADHD inattentive presentation (ADHD-I) called CBT for ADHD-I (CADDI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD Predominantly Inattentive Type
- What is being tested?
- Cognitive-behavioral therapy (Hesslinger protocol) and Cognitive-behavioral therapy (CADDI protocol)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Principal diagnosis of ADHD inattentive presentation
- 18 years of age or older
- If on medication, it needs to be well-established since three months, and
- Prior psycho-educational intervention
Who cannot join
- Intellectual impairment
- Substance use disorder
- Difficulties in adherence to medical or other treatment
- Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or
- Simultaneous psychological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group-Based Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: Randomized Controlled Trial
Using a randomized controlled design, standard treatment of group cognitive-behavioral therapy (CBT) according to the Hesslinger protocol is compared to a newly developed group treatment specifically designed for adult patients with ADHD inattentive presentation (ADHD-I) called CBT for ADHD-I (CADDI). Research setting is psychiatric outpatient clinics. Research hypotheses include: 1. The CADDI protocol is more effective than standard treatment in terms of behavioral activation, procrastination, depressive symptoms, functional impairment, and quality of life, 2. Is equally effective in terms of ADHD symptoms, 3. Is more appreciated and tolerable, and 4. Outcome is mediated by mindful awareness. Effects are followed up at 6 and 12 months post treatment.
- Conditions
- ADHD Predominantly Inattentive Type
- Being tested
- Cognitive-behavioral therapy (Hesslinger protocol), Cognitive-behavioral therapy (CADDI protocol)
- 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.
Cognitive-behavioral therapy (Hesslinger protocol)Behavioural
Cognitive-behavioral therapy in a group format focusing on improving symptoms of ADHD, specifically by using skills in counteracting hyperactivity and impulsiveness, and promoting mindful awareness.
Cognitive-behavioral therapy (CADDI protocol)Behavioural
Cognitive-behavioral therapy in a group format focusing on improving inattentive symptoms of ADHD, specifically by using skills in organizing, executing, and completing activity, and promoting mindful awareness.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral therapy (Hesslinger protocol) | Active comparator | Not described Receives: Behavioral: Cognitive-behavioral therapy (Hesslinger protocol) |
| Cognitive-behavioral therapy (CADDI protocol) | Experimental | Not described Receives: Behavioral: Cognitive-behavioral therapy (CADDI protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Activation for Depression Scale
Total score 0-150; higher scores represent increased activation
Measured: 14 weeks
Pure Procrastination Scale
Total score 12-60; higher scores represent more procrastination
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD Predominantly Inattentive TypeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Bohman, Karolinska Institutet
- Investigators
- Benjamin Bohman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090983
- Sponsor's protocol ID
- KI-2019-02444
- Status last verified
- Mar 2025
- First submitted
- 13 Sep 2019
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-Based Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04090983
- Acronym / sponsor ID
- KI-2019-02444
- Conditions
- ADHD Predominantly Inattentive Type
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Sep 2019 (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.
Using a randomized controlled design, standard treatment of group cognitive-behavioral therapy (CBT) according to the Hesslinger protocol is compared to a newly developed group treatment specifically designed for adult patients with ADHD inattentive presentation (ADHD-I) called CBT for ADHD-I (CADDI). Research setting is psychiatric outpatient clinics. Research hypotheses include: 1. The CADDI protocol is more effective than standard treatment in terms of behavioral activation, procrastination, depressive symptoms, functional impairment, and quality of life, 2. Is equally effective in terms of ADHD symptoms, 3. Is more appreciated and tolerable, and 4. Outcome is mediated by mindful awareness. Effects are followed up at 6 and 12 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy (Hesslinger protocol) | Active comparator | Behavioral: Cognitive-behavioral therapy (Hesslinger protocol) |
| Cognitive-behavioral therapy (CADDI protocol) | Experimental | Behavioral: Cognitive-behavioral therapy (CADDI protocol) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Principal diagnosis of ADHD inattentive presentation
- 18 years of age or older
- If on medication, it needs to be well-established since three months, and
- Prior psycho-educational intervention
Key exclusion criteria (5 listed)
- Intellectual impairment
- Substance use disorder
- Difficulties in adherence to medical or other treatment
- Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or
- Simultaneous psychological treatment
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 |
|---|---|---|
| Cognitive-behavioral therapy (Hesslinger protocol)Cognitive-behavioral therapy in a group format focusing on improving symptoms of ADHD, specifically by using skills in counteracting hyperactivity and impulsiveness, and promoting mindful awareness. | Behavioural | Cognitive-behavioral therapy (Hesslinger protocol) |
| Cognitive-behavioral therapy (CADDI protocol)Cognitive-behavioral therapy in a group format focusing on improving inattentive symptoms of ADHD, specifically by using skills in organizing, executing, and completing activity, and promoting mindful awareness. | Behavioural | Cognitive-behavioral therapy (CADDI protocol) |
Primary outcome
Behavioral Activation for Depression Scale
Time frame: 14 weeks
Total score 0-150; higher scores represent increased activation
Pure Procrastination Scale
Time frame: 14 weeks
Total score 12-60; higher scores represent more procrastination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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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.
Benjamin Bohman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy (Hesslinger protocol) and Cognitive-behavioral therapy (CADDI protocol) in people with ADHD Predominantly Inattentive Type, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 4 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioral Activation for Depression Scale (time frame: 14 weeks). The study lists 2 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 4 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.