Can Applying the Science of Habit Formation to Contemplative Practice Improve Outcomes? A Randomized Controlled Trial of a Single-Session Habit Formation Intervention for Self-Compassionate Touch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 497
- 试验地点
- 1
- 主要终点
- Practice Frequency
研究概览
简要总结
In the present study, the investigators will conduct a confirmatory efficacy trial to test whether improving practice automaticity (i.e., habit formation) of self-compassionate touch improves outcomes in the predicted direction. Adults (n=440, including 20% for attrition) will be randomly assigned to: (1) the self-compassionate touch intervention plus habit formation tools ("SCT+HABITS") versus (2) the self-compassionate touch intervention alone ("SCT"). The investigators will conduct assessments at baseline, 3-month follow-up, and 6-month follow-up. The SCT+HABITS condition will be used to evaluate whether providing habit formation tools results in superior effects to SCT. The intervention will be delivered entirely online.
详细描述
Specific Aim 1: Evaluate whether SCT+HABITS shows more practice frequency and practice automaticity from baseline to 3-month, and to 6-month follow-up compared to the SCT. Hypothesis 1. The SCT+HABITS group will show greater increases in practice frequency and practice automaticity than SCT from baseline to 3-month, and to 6-month follow-up.
Specific Aim 2: Determine whether SCT+HABITS, relative to SCT, will experience increased self-compassion and self-compassion automaticity, and reduced stress and psychopathology. Hypothesis 2. SCT+HABITS will promote greater increases in self-compassion and self-compassion automaticity, and greater reductions in stress and psychopathology from baseline to 3-month, to 6-month follow-up.
Specific Aim 3: Assess whether greater baseline to 3-month follow-up increases in practice automaticity mediate the association between SCT+HABITS and baseline to 6-month follow-up increases in (a) self-compassion and (b) self-compassion automaticity, as well as reductions in (c) stress and (d) psychopathology. Hypothesis 3. Greater baseline to 3-month follow-up increases in practice automaticity will mediate the association between the SCT+HABITS group and baseline to 6-month follow-up increases in (a) self-compassion and (b) self-compassion automaticity, as well as reductions in (c) stress and (d) psychopathology.
Exploratory Aim: Evaluate the barriers, facilitators, and acceptability of SCT+HABITS and SCT alone. This aim will be addressed via qualitative analyses to characterize barriers and facilitators to habit formation, and the proportion of participants in each condition (SCT+HABITS and SCT alone) who noted each type of barrier and facilitator. Participants will self-report on acceptability and feasibility via questionnaire. Then, the investigators will examine whether SCT+HABITS and SCT alone will meet or exceed the established criteria for acceptability and feasibility.
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)
盲法说明
Study participants will not be made aware that there are two experimental conditions. All will be told that they are receiving the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older.
- •English language proficiency.
- •Able and willing to give informed consent.
- •Resides in the United States of America
排除标准
- •Does not have email address or access to email.
- •Does not personally own a smartphone device
- •Not able/willing to participate in and/or complete the baseline assessments
研究组 & 干预措施
Self-Compassionate Touch Intervention Alone
All participants will receive the self-compassion intervention after completing their baseline assessment, which will contain the same instructions used in the initial study (see NCT05199779).
干预措施: Self-Compassionate Touch Intervention (Behavioral)
Self-Compassionate Touch Intervention Plus Habit Formation Tools
SCT+HABITS participants will receive the abovementioned procedures, and will also receive evidence-based tools for forming habits.
干预措施: Self-Compassionate Touch Intervention (Behavioral)
Self-Compassionate Touch Intervention Plus Habit Formation Tools
SCT+HABITS participants will receive the abovementioned procedures, and will also receive evidence-based tools for forming habits.
干预措施: Habit Formation Tools (Behavioral)
结局指标
主要结局
Practice Frequency
时间窗: Change from baseline to 3-month follow-up, and to 6-month followup
Number of times practiced self-compassion exercise per week since last assessment. 1 item. Higher frequency indicates a better outcome.
Practice Automaticity (Practice Self-Report Behavioral Automaticity Index [SRBAI])
时间窗: Change from baseline to 3-month follow-up, and to 6-month follow-up.
4 items, 1-9 scale. Higher scores indicate a better outcome.
次要结局
- Perceived Stress (Perceived-Stress Scale [PSS-10])(Change from baseline to 3-month follow-up, and to 6-month followup)
- Psychopathology (DSM-5 Cross-Cutting Measure [DSM-XC])(Change from baseline to 3-month follow-up, and to 6-month followup)
- Self-Compassion Automaticity (Self-Compassion Self-Report Behavioral Automaticity Index [SRBAI])(Change from baseline to 3-month follow-up, and to 6-month followup.)
- Self-Compassion (Sussex-Oxford Compassion for the Self Scale [SOCS-S])(Change from baseline to 3-month follow-up, and to 6-month followup)