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Clinical Trials/NCT05644028
NCT05644028
Completed
N/A

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

University of Bergen1 site in 1 country16 target enrollmentNovember 29, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
University of Bergen
Enrollment
16
Locations
1
Primary Endpoint
The Credibility and Expectancy Questionnaire (CEQ)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 29, 2022
End Date
April 18, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

Treatment adherence

Time Frame: Up to 12 weeks

Number of attended group sessions and number of completed homework assignments

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.

Secondary Outcomes

  • Difficulties in Emotion Regulation Scale (DERS)(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 Adult ADHD Self-Rating Scale (ASRS)(Up to 12 weeks)
  • The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A)(Up to 12 weeks)

Study Sites (1)

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