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临床试验/NCT06492824
NCT06492824已完成不适用

Intervention in Depression: Randomized Control Trial Examining a Fully Automated Mobile Behavioral Activation Intervention

Florida State University2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年11月1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
156
试验地点
2
主要终点
Change in anhedonia

研究概览

简要总结

The proposed project aims to examine the effectiveness of an automated digital (i.e., text message based) intervention prompting adults with at least moderate depressive symptoms to complete enjoyable daily activities (i.e., Behavioral Activation [BA]) over the course of one month compared to adults with moderate or more depressive symptoms that complete an active and a passive control condition broadly prompting a healthier lifestyle or no prompts at all. More specifically, we aim to examine if the BA intervention will improve mental health and overall well-being among adults experiencing moderate or more symptoms of depression over and beyond the active and passive control conditions. We will measure symptoms such as current depression, anxiety, and stress pre- and post- interventions to determine their effectiveness.

详细描述

Participants in the experimental (BA) condition will complete an introduction video about the intervention. They will then take a pre-intervention survey, after which they will choose five enjoyable activities from a large list. Daily text message reminders will be sent to BA participants in the morning to remind them to do their enjoyable activities for the day, as well as a link to a checklist where they will report how frequently they have completed any of their five activities from the previous day (example text message in documentation). At the end of the month, they will complete a follow-up survey consisting of the same measures from the pre-intervention survey.

Participants in the active control condition will complete mostly the same tasks as those in the experimental (BA) condition. They will then take a pre-intervention survey and choose five enjoyable activities from the same list; however, active control participants will not explicitly be asked to complete these activities for the intervention. Instead, participants in the active control condition will be promoted to complete tasks such as drinking more water, going to bed early, brushing their teeth, showering or bathing for that day, and eating well balanced meals. Daily text reminders will be sent about these healthy living activities in the morning. In that same message, they will receive a link to a checklist where they will report about their completed healthy living activities for the previous day (example text message in documentation).At the end of the month, they will also complete a follow-up survey consisting of the same measures from the pre-intervention survey. Importantly, participants in this condition will have the option to complete the BA digital intervention after completing the active control condition if they desire; however, these participants would not be paid for their time upon completing the BA intervention.

Finally, participants in the passive control condition will complete mostly the same tasks as those in the experimental (BA) and active control conditions. They will take a pre-intervention survey and choose five enjoyable activities from the same list; however, passive control participants will not explicitly be asked to complete these enjoyable activities or any of the healthy living activities during the month. To further clarify, passive control participants will not be enrolled in SlickText and will therefore not be sent daily text reminders or checklists. At the end of the month, they will also complete a follow-up survey consisting of the same measures from the pre-intervention survey. Importantly, participants in this condition will also have the option to complete the BA digital intervention after completing the passive control condition if they desire; however, these participants would not be paid for their time upon completing the BA intervention.

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 (Investigator)

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

  • PHQ-8 score greater than or equal to 10
  • 18 years or older
  • Had access to a cell phone

排除标准

  • 未提供

结局指标

主要结局

Change in anhedonia

时间窗: Collected at baseline and one month

Personality Inventory for DSM-5 (PID 5), anhedonia subscale, creates a score of current anhedonic symptoms consisting of 8 items. Scores range from 0-24, higher scores indicating more symptoms of anhedonia.

Change in depressive symptoms

时间窗: Collected at baseline and one month

Depression, Anxiety, and Stress Scale (DASS-21) creates a total score for depression based on 7 items. Scores range from 0-42, higher score indication more depression.

次要结局

未报告次要终点

研究者

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

Nick Santopetro

Co-Principal Investigator

Florida State University

研究点 (2)

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