跳至主要内容
临床试验/NCT04726813
NCT04726813已完成不适用

An Internet-delivered Intervention for Coping With ADHD in Adulthood - a Randomized Controlled Trial

University of Bergen1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年4月27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
120
试验地点
1
主要终点
Adult ADHD Quality of Life Measure (AAQol)

研究概览

简要总结

The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes.

详细描述

ADHD in adulthood, with an estimated prevalence of 2 - 3 %, is associated with challenges in daily life functioning. The availability of evidence-based psychological interventions for adults with ADHD is poor. Interventions delivered over the Internet might help to increase the availability of effective psychological interventions for this group. The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes. A minimum of 118 participants with a self-reported ADHD diagnosis will be included in the study. In phase 1 we will conduct a randomized controlled trial with two arms, 1) self-guided Internet-delivered intervention for coping with ADHD (N=59), 2) self-guided online psychoeducation (control group, N= 59), with a 3 month follow-up. After 3 months the second phase of the study starts. In this phase (II) the control group participants will receive an adaptive version of the Internet-delivered intervention. This includes adaptation of the order of the modules to the individual participant needs, with the use of rule-based and machine-learning based adaptation. Clinical outcomes in both phases are inattention, hyperactivity, quality of life and stress. Uptake, usage, adherence and satisfaction will be explored. Repeated measurers are at baseline, weekly during the intervention period, post-intervention and 3 months follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Adults with a self-reported diagnosis of ADHD (date, venue and diagnosing physician)
  • Access to and ability to use a computer, smartphone and the Internet.
  • Current problems with organizing daily activity and 17 points of more on at least one of the ASRS subscales
  • Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
  • Speaks, writes and reads Norwegian

排除标准

  • Current self-reported diagnosis of severe psychiatric illness such as borderline or antisocial personality disorder, bipolar disorder, ongoing substance abuse, and/or suicidal ideation assessed with item 9 on the MADRS
  • Participants who are taking prescribed ADHD medication have to be stable on the medication at least four weeks before the study and during the study.

结局指标

主要结局

Adult ADHD Quality of Life Measure (AAQol)

时间窗: Change in quality of life at 8 weeks

The AAQoL has 29 items designed to assess HRQL during the past two weeks among adults with ADHD.

The Adult ADHD Self-Rating Scale (ASRS)

时间窗: Change in ADHD symptoms at 8 weeks

The Adult ADHD Self-Rating Scale (ASRS) includes all the 18 symptoms of ADHD included in the diagnostic manual (DSM-5).

次要结局

  • The perceived stress scale (PSS)(Change in stress symptoms at 8 weeks)
  • The Patient Health Questionnaire-9 (PHQ-9)(Change in depression symptoms at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robin Maria Francisca Kenter

Principal investigator

University of Bergen

研究点 (1)

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