A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults with ADHD

NCT ID: NCT05644028

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2023-04-18

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emotion regulation Intervention

An 8-week blended intervention targeting emotion dysregulation in ADHD

Group Type: EXPERIMENTAL

Emotion Regulation Intervention for ADHD

Intervention Type: BEHAVIORAL

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.

Interventions

Emotion Regulation Intervention for ADHD

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 18 years old or older

2. A diagnosis of ADHD

3. Current problems with emotion regulation as indicated with a score above 80 on the Difficulties in Emotion Regulation Scale (DERS)

4. Access to a smartphone

Exclusion Criteria

1. Current self-reported diagnosis of severe psychiatric illness such as ongoing substance abuse or psychosis.

2. 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.

3. Other ongoing psychological treatment for ADHD or other psychiatric illnesses.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astri Lundervold, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

University of Bergen

Bergen, Vestland, Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 38231536 (View on PubMed)

Nordby 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.

Reference Type: BACKGROUND

PMID: 39833731 (View on PubMed)

Other Identifiers

494659

Identifier Type: -

Identifier Source: org_study_id