Clinical trial NCT05644028: A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults with ADHD
Official title: A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults with ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2022-12-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Up to 12 weeks
measure: Open questions on treatment satisfaction
timeFrame: Up to 12 weeks
measure: Treatment adherence
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Up to 12 weeks
measure: The Adult ADHD Self-Rating Scale (ASRS)
timeFrame: Up to 12 weeks
measure: The Adult ADHD Quality of Life Measure (AAQoL)
timeFrame: Up to 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Up to 12 weeks
measure: The Behavior Rating Inventory of Executive Functioning Adult version (BRIEF-A)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Vestland
Study officials:
affiliation: University of Bergen
name: Astri Lundervold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.