Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Depressive Symptoms
研究概览
简要总结
This study evaluates a Just-In-Time Adaptive Intervention (JITAI) aiming to foster social support processes for adults with elevated depressive symptoms awaiting outpatient psychotherapy. Utilizing a daily-level micro-randomized trial (MRT) design conducted over 21 days, participants are assessed six times daily. Participants are randomized across four conditions: (1) vulnerability-triggered, (2) vulnerability and receptivity-triggered, (3) support-need-triggered, and (4) a no-intervention control. The primary objective of this study is to evaluate the effectiveness of the JITAI in reducing daily depressive symptoms and increasing received social support (primary outcomes), as well as reducing daily loneliness and enhancing perceived social support (secondary outcomes). Furthermore, the study aims to compare the relative efficacy of three distinct triggering strategies to identify the most effective timing for intervention delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Due to the micro-randomized trial design, randomization occurs automatically and daily within the smartphone application. Consequently, participants are masked as they are not informed of which triggering strategy is active on any given day. Furthermore, because the intervention is delivered entirely through the app without human mediation, study personnel who interact with participants remain unaware of the specific experimental allocations at any given timepoint.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indicating to seek outpatient psychotherapy
- •elevated levels of self-reported depressive symptoms (Beck Depression Inventory-II (BDI) score > 13 (out of 63); Kühner et al., 2007)
- •owning a smartphone
- •signing the informed consent form
排除标准
- •first session for outpatient psychotherapy is scheduled within four weeks
- •suicidal ideation (values > 2 in BDI item 9)
- •presence of manic symptoms (Mood Disorder Questionnaire (MDQ) score > 7), - shift work
- •age below 18 or above 70
研究组 & 干预措施
Social Support JITAI triggered based on Vulnerability
The intervention will be delivered when at least one vulnerability indicator reaches a score of ≥ 5 on a 7-point scale. Original german wording can be found in on the repository of the Open Science Framework (OSF) at https://osf.io/r8mks.
Vulnerability indicators
Negative affect (single item):
"To what extent are you currently experiencing negative emotions?" 7-point Likert-Scale (1 = "I do not experience any negative emotions" to 7 = "I experience very strong negative emotions")
Stress (single item; self-developed):
"I'm feeling stressed at the moment." 7-point Likert-Scale (1 = "strongly disagree" to 7 = "strongly agree")
Loneliness (single item):
"I feel lonely at the moment." 7-point Likert-Scale, as above
Rumination (single item):
"I notice that I keep having the same negative thoughts over and over again." 7-point Likert-Scale, as above
Listlessness (single item; self-developed):
"I don't feel like doing anything right now." 7-point Likert-Scale, as above
干预措施: Social Support Just-in-Time Adaptive Intervention (Behavioral)
Social Support JITAI triggered based on Vulnerability and Receptivity
The intervention will be delivered when the vulnerability criterion (≥ 5) is met and the respondent answers "yes" to the receptivity item. The content of this intervention condition is slightly different to the other ones (conditions 1 + 3) as it allows for postponement of the intervention when one is not receptive. Original german wording can be found in on the repository of the Open Science Framework (OSF) at https://osf.io/r8mks.
Receptivity (single item; self-developed) "I am currently open to receiving support from this app which could help me to feel better." 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree")
干预措施: Social Support Just-in-Time Adaptive Intervention (Behavioral)
Social Support JITAI triggered based on Support Need
The intervention will be delivered when the participants indicate "yes" in the support need item. Original german wording can be found in on the repository of the Open Science Framework (OSF) at https://osf.io/r8mks.
Support need item (single item; self-developed) "Would it help you right now to talk to someone about how you're feeling?" (Yes / No)
干预措施: Social Support Just-in-Time Adaptive Intervention (Behavioral)
Control Condition
No interventions are delivered on the respective study days
结局指标
主要结局
Depressive Symptoms
时间窗: Measured in the evening of study days 1-21
PHQ-2, adapted for daily measurement "Today, I felt down, depressed, or hopeless." "Today, I had little interest or pleasure in my activities." (7-point Likert scale with 1 = "strongly disagree" to 7 = "strongly agree")
Received Social Support
时间窗: Measured in the evening of study days 1-21
"Today, I received emotional support from others." "Today, I received practical help from others." (7-point Likert scale with 1 = "strongly disagree" to 7 = "strongly agree") Before that the participants were shown a definition of emotional and practical support: "Support can be emotional (e.g., listening, offering comfort, encouraging, etc.) or involve practical assistance (e.g., giving advice, gathering information, running errands, etc.)."
次要结局
- Loneliness(Measured in the evening of study days 1-21)
- Perceived Social Support(Measured in the evening of study days 1-21)