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

NCT05644028 | Completed

• 1 other identifier: 494659
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  Up to 12 weeks

• Treatment adherence

  Number of attended group sessions and number of completed homework assignments

  Up to 12 weeks

Secondary Outcomes (5)

• Difficulties in Emotion Regulation Scale (DERS)

  Up to 12 weeks

• The Adult ADHD Self-Rating Scale (ASRS)

  Up to 12 weeks

• The Adult ADHD Quality of Life Measure (AAQoL)

  Up to 12 weeks

• Hospital Anxiety and Depression Scale (HADS)

  Up to 12 weeks

• The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A)

  Up to 12 weeks

Study Arms (1)

Emotion regulation Intervention

EXPERIMENTAL

An 8-week blended intervention targeting emotion dysregulation in ADHD

Behavioral: Emotion Regulation Intervention for ADHD

Interventions

Emotion Regulation Intervention for ADHD 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.

Emotion regulation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

University of Bergen

Bergen, Vestland, 5019, Norway

Location

Related Publications (2)

• 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.

  PMID: 38231536 BACKGROUND

• 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.

  PMID: 39833731 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Astri Lundervold, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 9, 2022
• Study Start: November 29, 2022
• Primary Completion: March 14, 2023
• Study Completion: April 18, 2023
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)