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Clinical Trial Summary

Rationale: Mindfulness is a popular therapeutic strategy that has a growing body of evidence suggesting it can improve a wide range of physical and psychological symptoms. Yet, confusion exists as to why mindfulness is effective as well as the most effective ways in which to teach and practice mindfulness. The present study will test a mindfulness training protocol to better understand the most effective ways to teach and practice mindfulness. Intervention: A group of video game players, or "gamers", will be instructed on how to play a video game of their choice in a more mindful way and compare this to an activity of daily functioning (i.e., folding laundry). Outcomes from self-report measures taken both before and after study activities will be tested against a control group of gamers who will perform the same study activities without the mindfulness induction. Objective or Purpose: The purpose of the present study is to test the effects of a brief, standardized mindfulness prompt in order to better understand effective ways to train mindfulness concepts. The mindfulness prompt will be applied to an intrinsically motivated activity (i.e., video game play for experienced gamers) and an activity of daily functioning (i.e., laundry folding) in order to evaluate the different effects of mindfulness practice when implemented with a popular leisure activity versus a less engaging activity of daily living. Study Population: This study will include adult "gamers" ages 18-65. A gamer is someone who engages in some form of digital video game play for a minimal average of three hours per week. A pre-screening measuring will rule out any participants who do not play video games with enough frequency to be considered a gamer. Study sessions will take place remotely overseen via a Zoom-based video call with study personnel. Another exclusion criteria will be an inability to speak with study personnel via Zoom or do not have a private area to perform the study activities. Study Methodology: To address the aims of this study a mixed-method, between- and within-group, counterbalanced study design will be employed. Thus, participants will be randomized to either a mindfulness or control condition with pre- and post-study-task self-report measures collected at two separate study sessions in order to statistically analyze the study hypotheses. Study Aims: The present study has one primary aim and several secondary aims: The primary aim is to test the beneficial effects of a standardized, brief mindfulness induction prior to the completion of two different activities (i.e., play a video game or fold laundry). A secondary aim is to evaluate the impact that the type of activity has on one's ability to practice mindfulness. In addition to the primary and secondary aims, an exploratory analysis will be utilized in order to better understand what factors may have mediated the results from the first two aims. Study Outcomes or Endpoints: A main effect will be used to test the differences between the study manipulation (i.e., mindfulness prompt) and control (i.e., perform the task as you usually do) conditions. The primary outcome will be a self-reported state-mindfulness scale that measures the degree to which one "mindfully" performed a specific activity. Secondary outcomes will capture changes in emotions from pre- to post-activity, level of engagement or "flow" during the activity, enjoyment performing study activities, and level of focus/concentration during study activities. Follow-up: No follow-up is planned at this time. A baseline screening measure as well as in-session pre and post-study task questions will be the only data collected. Statistics and Plans for Analysis: For the primary aim of the study, a repeated measures multivariate analysis of variance (MANOVA) with a 2 (study group) X 2 (activity type) X 2 (state mindfulness) matrix. The second study aim will be tested with a repeated measures multivariate analysis of covariation (MANCOVA) with the covariates of changes in emotions from pre- to post-activity, level of engagement or "flow" during the activity, enjoyment performing study activities, and level of focus/concentration during study activities.

Clinical Trial Description

The present study has been designed to address several shortcomings in the "mindfulness" literature. Mindfulness has been defined as, "paying attention in a particular way: on purpose, in the present moment, and nonjudgmentally." Mindfulness-based interventions have shown an ability to alleviate a wide range of psychological disorders including anxiety and depression and have been integrated into many popular and evidence-based psychotherapeutic modalities including Cognitive Behavioral Therapy (CBT), Dialectical-Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT), to name a few. Consequently, a better understanding of the most effective ways to teach mindfulness may help improve the positive effects of existing mindfulness-based interventions and may also inform future intervention and dissemination strategies based on this technique. One shortcoming of existing mindfulness research is that little consensus exists on how to operationalize the practice of mindfulness and few studies exist in which mindfulness is taught using a brief, standardized method. This is problematic because a lack of such brief and standardized training methods has led to inconsistencies and broad differences in how mindfulness interventions, to date, have defined, operationalized, and applied mindfulness principles and practice strategies. Moreover, it has been suggested that this literature suffers from an over-reliance on long-term, randomized clinical trials, which has resulted in a lack of controlled laboratory-based studies in which the mediating variables responsible for observed changes can be tested. Stated another way, mindfulness lacks research that is controlled, systematic and laboratory-based. Consequently, investigators still understand little about why mindfulness is effective as well as what factors may enhance or hinder one's ability to learn mindfulness strategies. A nebulous understanding of how to operationalize mindfulness and what mechanisms are responsible for change within mindfulness-based interventions should be addressed because the effectiveness of such interventions may be limited and may also lead to misattributions for what factors are mediating the positive effects demonstrated in these interventions. The present study will address this limitation by replicating an existing mindfulness study in which a brief, standardized mindfulness intervention was compared to a control group. The present study will apply similar mindfulness instructions to a different set of activities. This mindfulness manipulation will be compared to a control group receiving no mindfulness instructions. The first aim of this study, to test a brief, standardized mindfulness prompt prior to the completion of an activity, is meant to address the aforementioned shortcomings in current mindfulness literature. This study will be a partial replication of a systematic investigation conducted by Hanley, who tested a brief, standardized mindfulness induction prior to the completion of an instrumental activity of daily living (i.e., dishwashing) and compared the effects to a control group performing the same activity with no mindfulness prompt. Instrumental activities of daily living like meal preparation, shopping and cleaning are often used to teach mindfulness. Hanley found that participants in the mindfulness condition reported significantly greater levels of mindfulness during the activity, greater levels of positive emotions following the task, more engagement in the activity, and significantly lower levels of negative emotions as compared to the control condition. The present study will employ a similar set of mindfulness instructions prior to the completion of a different activity of instrumental daily living, folding laundry. A similar set of outcomes in relation to state-mindfulness, current emotional states, and experience performing the activity will also be utilized in the present study. This study will be a partial replication and extension of Hanley work. If similar results are observed in the present study it will suggest that brief, standardized mindfulness interventions may be flexibly applied to a wide range of activities. This, in turn, may help increase the opportunities one has to practice mindfulness throughout the day. Consistent practice has been demonstrated to be one of the most important factors in learning mindfulness. Thus, a brief, standardized set of mindfulness instructions that can be flexibly applied to a number of activities may improve the effectiveness of future mindfulness interventions. The second aim, which is intended to better understand the impact that type of activity has on a mindfulness prompt, may also help further mindfulness literature in several important ways. First, evidence suggests that in addition to consistent practice, feeling engaged and motivated while practicing may also help enhance mindfulness training. By asking participants to complete an activity after receiving mindfulness instructions for both video game play (VGP) and folding laundry the present study will be able to directly compare the differences between mindfulness training when applied to an engaging activity versus a routine activity. VGP was chosen to represent an engaging activity because VGP is a popular global activity that is practiced by millions of people on a daily basis. It has been suggested that VGP may represent an ideal platform in which to teach mindfulness because the real-time feedback and interactivity they provide can keep a user continuously engaged and immersed in the present moment. Much of the engagement and immersion observed during VGP studies may be attributed to the fact that many people find VGP to be a fun, enjoyable, intrinsically motivated activity. Intrinsic motivation, the motivation one feels to engage in activities that they enjoy, has been consistently shown to be one of the most powerful forms of human motivation. Further, people tend to feel the greatest sense of satisfaction and enjoyment when they engage in intrinsically motivated activities. Another reason VGP was selected as an activity for the present study is the emerging body of literature that suggests VGP can act as a platform for psychoeducation and enhance a wide range of behavioral and mental health functions including improved emotion regulation, ability to navigate negative emotions, problem solving, and social interactivity. In sum, this study is needed in order to better understand optimal ways in which to train and practice mindfulness. More studies like this are needed because the current mindfulness literature lacks systematic investigations of brief, standardized training methods. This has led to a dearth of knowledge about how to operationalize the term "mindfulness" as well as why existing mindfulness interventions have been effective. The present study will address these shortcomings by comparing a brief, standardized mindfulness manipulation when applied to VGP and laundry folding. A between-subjects analysis will be used to test the effects of the mindfulness prompt when compared to a control group. A within-subject analysis will be used to test whether the application of mindfulness to an enjoyable activity (i.e., video game play) produces greater effects than when it is applied to a more routine activity (i.e., folding laundry). This is intended to help inform future mindfulness interventions by providing more insight into effective ways to teach and practice mindfulness. Risks to participants: This study will present minimal risk to the participants for a variety of reasons. First, a brief screening measure will be used to exclude participants who don't meet our inclusion criteria (including screen out minors). Second, the two study tasks are non-invasive and present no health risks to participants. Specifically, folding laundry and playing a self-selected video game are common activities that participants should be familiar with and that present no inherent dangers to the participants. Third, the questionnaires within the study will be focused on assessing how participants are currently feeling and how they felt about the performance of study task from a variety of questionnaires. Since the questions are tied to a specific task and current thoughts and feelings, they should not present any prompts that participants would find distressing or offensive. Fourth, the mindfulness prompt in this study will be modeled after an existing study which demonstrated effectiveness in teaching participants principles of mindfulness when compared to a control group while also presenting minimal risk to participants. Finally, it will be made clear to participants during the informed consent process that they will be able to leave the study at any time and that they are under no obligation to complete both study sessions. Given these reasons, it is believed the present study does not present any undue risks to participants. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04551976
Study type Interventional
Source University of Southern California
Status Completed
Phase N/A
Start date August 20, 2020
Completion date January 1, 2021

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