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Completed

NCT Number: NCT05644028

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

The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adults with ADHD.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Vestland, 5019, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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.

  3. Treatment adherence

    Time frame: Up to 12 weeks

    Number of attended group sessions and number of completed homework assignments

Secondary outcomes

  1. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: Up to 12 weeks

    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.

  2. The Adult ADHD Self-Rating Scale (ASRS)

    Time frame: Up to 12 weeks

    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.

  3. The Adult ADHD Quality of Life Measure (AAQoL)

    Time frame: Up to 12 weeks

    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.

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Up to 12 weeks

    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.

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

    Time frame: Up to 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Haukeland University Hospital

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2022
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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