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临床试验/NCT05644028
NCT05644028已完成不适用

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

University of Bergen2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
The Credibility and Expectancy Questionnaire (CEQ)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

The Credibility and Expectancy Questionnaire (CEQ)

时间窗: 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

时间窗: Up to 12 weeks

Number of attended group sessions and number of completed homework assignments

Open questions on treatment satisfaction

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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