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临床试验/NCT05623826
NCT05623826已完成不适用

Feasibility and Efficacy of Imager, a Digital Training Intervention to Increase Reward Sensitivity: A Randomised Controlled Trial

University of Zurich2 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2020年9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
137
试验地点
2
主要终点
State-Trait Anxiety Inventory (STAI)

研究概览

简要总结

Development and feasibility test of an Ecological Momentary Intervention (EMI) - Imager, to promote and improve stress resilience, specifically to increase reward sensitivity.

详细描述

Aim of the current project is to develop and test Ecological Momentary Intervention (EMI) - Imager, to promote and improve stress resilience, specifically to increase reward sensitivity. EMIs are mostly smartphone-based applications that deliver interventions to people as they go about in their daily lives. The EMI developed and tested here is based on theoretical and empirical findings and consists of several items and a repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones.

This study tests the feasibility and effects of the EMI on a change in (i) reward sensitivity, (ii) mental imagery, and (iii) indices of perceived stress. One hundred twenty healthy student participants, aged 18-29 will be included in the study. Participants will be screened first and included if they score 5 points or more on the Reward Sensitivity Subscale of Behavioral Avoidance/Inhibition (BIS/BAS) scales. This is necessary in order to avoid a ceiling effect. Then, participants will be randomly assigned to an experimental (reward sensitivity EMI) or two of the control conditions (control EMA or waitlist). The reward sensitivity EMI group will be taught about experiencing rewards in daily life and will be asked to apply the specific techniques to personal situations repeatedly. The control EMA group will use the same app consisting of Ecological Momentary Assessment only, and the waitlist group will not receive any mobile app.

The training will last seven consecutive days and the app will send (i) 10 prompts per day to ask about the current mood of the user in control EMA and experimental groups and (ii) three prompts per day resulting in a total of 21 reward training sessions only in the experimental group. Participants will be able to use a special button triggering the intervention or EMA by themselves too. After one week, participants will return to the lab, fill in questionnaires and participate in behavioral tasks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants are informed of the two group design, individual group allocation is released to participants at the end of the study participation.

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • being a student
  • having sufficient knowledge of the German language
  • being a smartphone user
  • score of 5 points or more in Reward Sensitivity Subscale of Behavioral Avoidance/Inhibition (BIS/BAS) scales

排除标准

  • having a mental illness or attending the psychotherapy

结局指标

主要结局

State-Trait Anxiety Inventory (STAI)

时间窗: one week: Pre- to post-intervention/control

Self-reported anxiety symptoms, scale range \[20-80\], higher score = worse outcome

The Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ)

时间窗: one week: Pre- to post-intervention/control

Self-reported reward sensitivity, scale range \[0-24\], higher score = better outcome

Behavioural avoidance/inhibition (BIS/BAS) scales

时间窗: one week: Pre- to post-intervention/control

Self-reported reward sensitivity, scale range \[0-15\], higher score = worse outcome

Beck Depression Inventory II (BDI-II)

时间窗: one week: Pre- to post-intervention/control

Self-reported depressive symptoms, scale range \[0-63\], higher score = worse outcome

Perceived Stress Scale (PSS)

时间窗: one week: Pre- to post-intervention/control

Self-reported level of stress, scale range \[0-40\], higher score = worse outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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