跳至主要内容
临床试验/NCT05434429
NCT05434429Unknown不适用

Evaluating the Effectiveness of a Smartphone App to Reduce Craving and Lapse Risk in Problematic Behaviors and Substance Use

PredictWatch2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
2
主要终点
Craving level according to EMA self-report

研究概览

简要总结

The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in problematic behaviors (compulsive sex, pornography, overeating, gaming, gambling) and substance use (cannabis, nicotine). Participants are randomly assigned to either the intervention group or the control. Participants in the intervention group have access to short-term and long-term interventions, whereas those in the control group only have access to the weekly ecological momentary assessment reports. Participants in the intervention group are able to access the intervention materials 5 days after enrollment and receive weekly ecological momentary assessment reports. Those in the control group will be granted access to all intervention materials after five weeks following study enrollment. A questionnaire battery assessments is administered (1) at baseline in the first week following onboarding in; (2) after 5 weeks; (3) after six months. In addition, longitudinal data on several variables related to craving and lapse risk are collected daily using ecological momentary assessment

详细描述

The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in problematic behaviors and substance use.

Two main self-guided intervention modules are available. Short-term self-guided intervention module include mainly audio-guided sessions on gratitude, thoughts management, auto-empathy, and relaxation. Moreover, there based on breath relaxation exercises, craving management, and motivation to change Long-term self-guided intervention module include CBT-based interventions, meditations, mindfulness, and journaling.

Participants are recruited via newsletters, local and nation-wide advertisements, as well as through social media. The study is conducted via a mobile application "Nałogometr", freely available to participants. We recruit people from the general population residing in Poland.

To compare the effectiveness of mobile app-based self-guided psychological interventions, study participants are randomly assigned to either the intervention group or the control.

Experimental conditions are balanced based on multiple variables provided during onboarding: (1) main addiction type; (2) participation in addiction-related therapy; (3) gender; (4) age; (5) addiction severity; (6) abstinence duration.

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

入选标准

  • are at least 18 years of age
  • speak Polish fluently
  • use either an Android or iOS smartphone

排除标准

  • 未提供

研究组 & 干预措施

Control

No Intervention

Given access to all interventions at the end of the 5 weeks of the trial.

Intervention

Experimental

Participants have access to short-term and long-term interventions.

干预措施: mobile application (Other)

结局指标

主要结局

Craving level according to EMA self-report

时间窗: 5 weeks

Collected daily via the participant's smartphone; an item asking how strong is one's urge to use \[substance\] at the moment on a scale of 0 to 6 (none - incalculable ). The score will be tracked for changes over time.

Lapses rate according to EMA self-report

时间窗: 5 weeks

Collected daily via the participant's smartphone; an item asking whether or not the lapse occurred since the last survey (yes / no). The score will be tracked for changes over time.

次要结局

  • Severity of Dependence Scale(1 week, 5 weeks, 6 months)
  • Brief Pornography Screen-PL(1 week, 5 weeks, 6 months)
  • Compulsive Sexual Behavior Disorder(1 week, 5 weeks, 6 months)
  • Binge Eating Disorder Screener-7(1 week, 5 weeks, 6 months)
  • Drug Use Disorders Identification Test(1 week, 5 weeks, 6 months)
  • The Cannabis Use Disorder Identification Test - Revised(1 week, 5 weeks, 6 months)
  • The Hospital Anxiety Depression Scale(1 week, 5 weeks, 6 months)
  • The Fagerstrom Test for Nicotine Dependence(1 week, 5 weeks, 6 months)
  • Satisfaction with Life Scale(1 week, 5 weeks, 6 months)
  • Internet Gaming Disorder Scale-Short-Form(1 week, 5 weeks, 6 months)
  • The South Oaks Gambling Screen(1 week, 5 weeks, 6 months)

研究者

发起方
PredictWatch
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验