Attention Deficit Hyperactivity DisorderNCT05644028
A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults With ADHD
A study testing Emotion Regulation Intervention for ADHD in people with Attention Deficit Hyperactivity Disorder, run by University of Bergen at 1 site in Norway.
Trial summary
The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adults with ADHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Emotion Regulation Intervention for ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 29 Nov 2022to 18 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- A diagnosis of ADHD
- Current problems with emotion regulation as indicated with a score above 80 on the Difficulties in Emotion Regulation Scale (DERS)
- Access to a smartphone
Who cannot join
- Current self-reported diagnosis of severe psychiatric illness such as ongoing substance abuse or psychosis.
- High risk of suicidality, as indicated by a) has attempted suicide within the last year, b) has previously attempted suicide and reports suicidal ideation, or c) reports current ideations and has a plan or preferred method.
- Other ongoing psychological treatment for ADHD or other psychiatric illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adults with ADHD.
Read the detailed description
Adults with ADHD with co-occurring deficits in emotion regulation are expected to have more severe impairment than those without such deficits in several life domains. Both pharmacological and psychological treatment interventions for adults with ADHD tend to target core symptoms of inattention and hyperactivity, and there are few available interventions targeting emotional symptoms. The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in ADHD. The intervention consists of eight face-to-face group sessions and a companion app to be used by the participants between the sessions for skills training. The investigators seek to recruit between 15 to 20 adults with ADHD to participate in the pilot study. Feasibility outcomes include adherence, treatment satisfaction and treatment credibility. Self-report questionnaires assessing emotion dysregulation, ADHD symptoms, quality of life, anxiety and depression will be used to examine preliminary clinical effects. There will also be conducted qualitative process interviews to examine the participants expectations and experiences with the program. The investigators expect the intervention to be feasible and to find positive preliminary effects. The findings from the study will be of importance for to further improve the intervention for for a future randomized-controlled trial.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Emotion Regulation Intervention for ADHD
- 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.
Emotion Regulation Intervention for ADHDBehavioural
The intervention will be based on principles from dialectic behavioral therapy. The overall aim of the intervention is to improve emotion regulation skills. The intervention will consist of eight face-to-face group sessions and a digital companion app that the participants can use to practice skills between the sessions. The groups will include mindfulness-based exercises, homework review, introduction to new skills, and peer discussions.
| Study group | Role | What they receive |
|---|---|---|
| Emotion regulation Intervention | Experimental | An 8-week blended intervention targeting emotion dysregulation in ADHD Receives: Behavioral: Emotion Regulation Intervention for ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Credibility and Expectancy Questionnaire (CEQ)
The third item from the The Credibility and Expectancy Questionnaire (CEQ) will be used to assess treatment credibility. The third item states "How confident would you be in recommending this treatment to a friend with similar challenges? The item is rated on a scale from 1 (none at all confident) to 9 (very confident)
Measured: Up to 12 weeks
Open questions on treatment satisfaction
At the post-intervention assessment, the participants will be asked whether they are likely to continue using the exercises from the intervention in the future and whether they have experienced any adverse events, where the participants will have the option to elaborate in an open text-field. There will also be conducted qualitative interviews with the participants to examine their experiences (positive and negative) with the program.
Measured: Up to 12 weeks
Treatment adherence
Number of attended group sessions and number of completed homework assignments
Measured: Up to 12 weeks
Secondary outcomes (5)
Difficulties in Emotion Regulation Scale (DERS)
The measure is a self-report questionnaire that is commonly used to assess emotion dysregulation in clinical populations. The scale includes 36 items rated on a 5-point scale ranging from "Never" (1) to "Almost always" (5), yielding a total score of between 36 - 180, where a higher score indicate a higher degree of emotion dysregulation.
Measured: Up to 12 weeks
The Adult ADHD Self-Rating Scale (ASRS)
The scale assesses symptoms of inattention (nine items), and symptoms of hyperactivity-impulsivity (nine items) and includes a total of 18 items. The response type consists of a 5-point scale with options "Never" (0), "Rarely" (1), "Sometimes" (2), "Often" (3) or "Very Often" (4) giving the scale a maximum score of 72 for full-scale ASRS and 36 on each of the two subscales of inattention and hyperactivity-impulsivity. A higher score indicate a higher severity in symptoms.
Measured: Up to 12 weeks
The Adult ADHD Quality of Life Measure (AAQoL)
The measure assesses quality of life during the past two weeks and is specifically developed for adults with ADHD. The scale comprises 29 items rated on a scale from "Not at all/Never" (1) to "Extremely/Very Often" (5), yielding a total score between 0 - 100 points. The scale also included four subscales: life productivity, psychological health, life outlook, and relationships, all yielding a score between 0 - 100 points. A higher score indicates better quality of life.
Measured: Up to 12 weeks
Hospital Anxiety and Depression Scale (HADS)
The scale examine symptoms of depression and anxiety. The scale consists of 14 items with response options ranging from 0-3, with 3 being the most severe level of symptoms. The scale yields one total score, ranging from 0-42, and one subscale score from depression, and one subscale for anxiety, ranging from 0-21.
Measured: Up to 12 weeks
The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A)
The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A) is a self-report questionnaire assessing executive functioning in everyday life. The scale consists of 75 items and are rates on a 3-point scale from "Never" (1) to "Often" (3).
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start29 Nov 2022
- Primary completion14 Mar 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Astri Lundervold, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644028
- Sponsor's protocol ID
- 494659
- Status last verified
- Mar 2025
- First submitted
- 21 Nov 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nordby ES, Guribye F, Schonning V, Andersen SL, Kuntsi J, Lundervold AJ. A Blended Intervention Targeting Emotion Dysregulation in Adults With Attention-Deficit/Hyperactivity Disorder: Development and Feasibility Study. JMIR Form Res. 2024 Jan 17;8:e53931. doi: 10.2196/53931.
PubMed 38231536Nordby ES, Schonning V, Barnes A, Denyer H, Kuntsi J, Lundervold AJ, Guribye F. Experiences of change following a blended intervention for adults with ADHD and emotion dysregulation: a qualitative interview study. BMC Psychiatry. 2025 Jan 20;25(1):56. doi: 10.1186/s12888-025-06476-1.
PubMed 39833731
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults With ADHD
- ClinicalTrials.gov ID
- NCT05644028
- Acronym / sponsor ID
- 494659
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 9 Dec 2022 (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.
The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adults with ADHD.
Detailed description
Adults with ADHD with co-occurring deficits in emotion regulation are expected to have more severe impairment than those without such deficits in several life domains. Both pharmacological and psychological treatment interventions for adults with ADHD tend to target core symptoms of inattention and hyperactivity, and there are few available interventions targeting emotional symptoms. The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in ADHD. The intervention consists of eight face-to-face group sessions and a companion app to be used by the participants between the sessions for skills training. The investigators seek to recruit between 15 to 20 adults with ADHD to participate in the pilot study. Feasibility outcomes include adherence, treatment satisfaction and treatment credibility. Self-report questionnaires assessing emotion dysregulation, ADHD symptoms, quality of life, anxiety and depression will be used to examine preliminary clinical effects. There will also be conducted qualitative process interviews to examine the participants expectations and experiences with the program. The investigators expect the intervention to be feasible and to find positive preliminary effects. The findings from the study will be of importance for to further improve the intervention for for a future randomized-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emotion regulation Intervention | Experimental | Behavioral: Emotion Regulation Intervention for ADHDAn 8-week blended intervention targeting emotion dysregulation in ADHD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- A diagnosis of ADHD
- Current problems with emotion regulation as indicated with a score above 80 on the Difficulties in Emotion Regulation Scale (DERS)
- Access to a smartphone
Key exclusion criteria (3 listed)
- Current self-reported diagnosis of severe psychiatric illness such as ongoing substance abuse or psychosis.
- High risk of suicidality, as indicated by a) has attempted suicide within the last year, b) has previously attempted suicide and reports suicidal ideation, or c) reports current ideations and has a plan or preferred method.
- Other ongoing psychological treatment for ADHD or other psychiatric illnesses.
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 |
|---|---|---|
| Emotion Regulation Intervention for ADHDThe intervention will be based on principles from dialectic behavioral therapy. The overall aim of the intervention is to improve emotion regulation skills. The intervention will consist of eight face-to-face group sessions and a digital companion app that the participants can use to practice skills between the sessions. The groups will include mindfulness-based exercises, homework review, introduction to new skills, and peer discussions. | Behavioural | Emotion regulation Intervention |
Primary outcome
The Credibility and Expectancy Questionnaire (CEQ)
Time frame: Up to 12 weeks
The third item from the The Credibility and Expectancy Questionnaire (CEQ) will be used to assess treatment credibility. The third item states "How confident would you be in recommending this treatment to a friend with similar challenges? The item is rated on a scale from 1 (none at all confident) to 9 (very confident)
Open questions on treatment satisfaction
Time frame: Up to 12 weeks
At the post-intervention assessment, the participants will be asked whether they are likely to continue using the exercises from the intervention in the future and whether they have experienced any adverse events, where the participants will have the option to elaborate in an open text-field. There will also be conducted qualitative interviews with the participants to examine their experiences (positive and negative) with the program.
Treatment adherence
Time frame: Up to 12 weeks
Number of attended group sessions and number of completed homework assignments
5 secondary outcomes
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Up to 12 weeks
The Adult ADHD Self-Rating Scale (ASRS)
Time frame: Up to 12 weeks
The Adult ADHD Quality of Life Measure (AAQoL)
Time frame: Up to 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 12 weeks
The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A)
Time frame: Up to 12 weeks
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 17 Mar 2025.
- Results publication: PubMed 38231536Nordby ES, Guribye F, Schonning V, Andersen SL, Kuntsi J, Lundervold AJ. A Blended Intervention Targeting Emotion Dysregulation in Adults With Attention-Deficit/Hyperactivity Disorder: Development and Feasibility Study. JMIR Form Res. 2024 Jan 17;8:e53931. doi: 10.2196/53931.
- Results publication: PubMed 39833731Nordby ES, Schonning V, Barnes A, Denyer H, Kuntsi J, Lundervold AJ, Guribye F. Experiences of change following a blended intervention for adults with ADHD and emotion dysregulation: a qualitative interview study. BMC Psychiatry. 2025 Jan 20;25(1):56. doi: 10.1186/s12888-025-06476-1.
- 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.
Astri Lundervold, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Intervention for ADHD in people with Attention Deficit Hyperactivity Disorder, run by University of Bergen at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 17 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 Norway. 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?
The Credibility and Expectancy Questionnaire (CEQ) (time frame: Up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644028, which also lists 2 linked publications.
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 17 Mar 2025.