Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT05866718
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT05866718
Study Brief:
Protocol Section:
NCT05866718