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临床试验/NCT05235243
NCT05235243已完成不适用

Can Mindfulness Meditation and Self-monitoring Can Help Improve Control Over Maladaptive Daydreaming: A Randomized Controlled Trial of a Self-guided Web-based Program

University of Haifa1 个研究点 分布在 1 个国家目标入组 697 人开始时间: 2018年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
697
试验地点
1
主要终点
Change from baseline in maladaptive daydreaming

研究概览

简要总结

Maladaptive daydreaming (MD) is a compulsive form of daydreaming that causes distress and functional impairment among tens of thousands of self-diagnosed sufferers. This is the first controlled treatment trial for MD. The investigators built an internet-based self-help program for MD and tested the effectiveness of mindfulness and self-monitoring in improving control over MD, comparing three groups across three measurement points in time.

详细描述

Objective

Maladaptive daydreaming (MD) is a compulsive form of daydreaming that causes distress and functional impairment among tens of thousands of self-diagnosed sufferers. This is the first controlled treatment trial for MD. Method: The investigators built an internet-based self-help program for MD and tested the effectiveness of mindfulness and self-monitoring in improving control over MD, compared to internet-based support as usual (waiting-list group). Participants were randomly assigned to three groups and measured across three points in time (baseline, post-intervention, and 6 months follow-up). The investigators measured the change in daydreaming pathology (MDS-16), daydreaming frequency (DDFS), and daydreaming functioning (DWSAS), alongside changes in psychiatric symptoms (BSI), and intervention outcome (OQ). Changes in mindful attention and awareness skills, compliance with program requirements, and feedback to the program were also measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •Age above 18 years
  • •MD diagnosis
  • •Not being in any concurrent treatment for MD
  • •English fluent
  • •Daily access to the internet, and to a device with internet access
  • •Give informed consent to the study
  • •Respondents who reported being on a stable dose of medication for at least three months could take part in the study provided that they did not change their dosages while participating in the study.

排除标准

  • •Age under 18 years
  • •No MD diagnosis
  • •In concurrent psychology therapy for MD
  • •Not fluent in English
  • •Not having a daily internet access
  • •Taking medication for less than three months

研究组 & 干预措施

The Full Intervention (FI) group

Experimental

The full intervention (FI) group received a psycho-education module about MD and its addictive behavior mechanism, a motivation enhancement module based on motivational interviewing, mindfulness modules, and self-monitoring modules.

干预措施: Online therapeutic intervention for maladaptive daydreaming based on mindfulness and self-monitoring (Other)

The partial intervention (PI) group

Active Comparator

The partial intervention (PI) group received an intervention identical to the FI group (a psycho-education module about MD and its addictive behavior mechanism, a motivation enhancement module based on motivational interviewing, mindfulness modules) with the exclusion of the self-monitoring modules.

干预措施: Online therapeutic intervention for maladaptive daydreaming based on mindfulness (Other)

Waiting List (WL) group

No Intervention

Waiting List (WL) group did not undergo any intervention during the study period. However, WL participants were told that the program will commence in three months. During their waiting time participants were instructed to reduce their daydreaming activity to the best of their ability. Since all participants were recruited for this study from an online support forum (that is not part of this research design), the investigators labeled WL as the Internet Support as Usual (ISAU) group.

结局指标

主要结局

Change from baseline in maladaptive daydreaming

时间窗: Baseline, post, and follow-up (8 month total)

Change in the 16-item Maladaptive Daydreaming Scale (MDS-16) compared to baseline, measured 2 months and 6 months post-intervention. The MDS-16 is the primary self-report scale that gauges maladaptive daydreaming on a 10-point Likert scale. Scores range from 0 to 100, with the mean score of 40 set as an evidence-based cut-off score for clinical-level MD. Higher scores indicate an elevated level of maladaptive daydreaming, hence, a worse outcome.

Change from baseline in daydreaming frequency

时间窗: Baseline, post, and follow-up (8 month total)

Change in the Daydreaming Frequency Scale (DDFS) compared to baseline, measured 2 months and 6 months post-intervention. The DDFS is a 12-item subscale of the Imaginal Processes Inventory, gauging reported daydreaming frequency. Items are marked on a 5-point Likert scale. Scores range from 12 to 60. Higher scores indicate an elevated frequency of daydreaming, hence, a worse outcome.

Change from baseline in work and social adjustment

时间窗: Baseline, post, and follow-up (8 month total)

Change in the Daydreaming Work and Social Adjustment Scale (DWSAS) compared to baseline, measured 2 months and 6 months post-intervention. The DWSAS is a 6-item measure assessing adjustment and disfunction in relation to daydreaming. Items are ranked on a 9-point Likert scale ranging from 0 to 8. The DWSAS scores range from 0 to 48. A score of 12 or lower indicates "no pathology and disfunction". Scores between 12 and 24 indicate "pathology and impaired function", while scores of 24 or above suggest "severe pathology and impaired function".

次要结局

  • Change from baseline in psychiatric symptoms(Baseline, post, and follow-up (8 month total))
  • Change from baseline in intervention outcome(Baseline, post, and follow-up (8 month total))

研究者

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

Eli Somer

Professor Eli Somer

University of Haifa

研究点 (1)

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