Depression MildGAMESNCT04551976
Habits of Gamers Study
A study testing Mindfulness in people with Depression Mild and Depression, Anxiety, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Mild, Depression, Anxiety, Anxiety
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-64
- "Gamer" = must play at least 3 and no more than 30 hours per week
- Must read and speak English
- Must have a private area, of the participant's choosing, in which to complete the two study sessions Must be able to speak with study personnel via Zoom
Who cannot join
- "Gamer" = less than 3 hours of play per week, or more than 30 hours per week Prior experience with mindfulness in the form of
- "Formal Mindfulness Training". Formal mindfulness training is considered any class, group, or training that was done via individual group psychotherapy, with a licensed mental health professional.
- Be able to fluently read and speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychology; University of Southern California, Seely G Mudd Building
Los Angeles, California, 90089
About this study
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.
Read more
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.
Read the detailed 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.
- Being tested
- Mindfulness
- Keywords
- mindfulness
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Pay attention to the present moment, on purpose, in a nonjudgemental way.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Video Game Then Laundry Group | Experimental | Receive mindfulness prompt and play their video game first and fold laundry second. Receives: Behavioral: Mindfulness |
| Mindful Laundry Then Video Game Group | Experimental | Receive mindfulness prompt and fold laundry first, play their video game second. Receives: Behavioral: Mindfulness |
| Control Video Game Then Laundry Group | No intervention | Control condition that receives no mindfulness prompt and is asked to complete activities like they normally would. They will play their video game first and fold laundry second. |
| Control Laundry Then Video Game Group | No intervention | Control condition that receives no mindfulness prompt and is asked to complete activities like they normally would. They will fold laundry first and will play their video game second. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Affect Schedule (PANAS-X)
The Positive and Negative Affect Schedule is a 5-point Likert scale with a minimum value of "1" (very slightly or not at all) and a maximum value of "5" (extremely). The Positive and Negative Affect Schedule measures participants' emotions/affect in the present moment. For this study the Positive and Negative Affect Schedule will be administered prior to and then immediately following a study activity and the change score from pre- to post-activity will constitute a primary outcome. Higher scores on the Positive and Negative Affect Schedule indicates more extreme emotional experiences.
Measured: Administered prior to the intervention to 10 minutes after the intervention for sessions 1 and 2.
State Mindfulness Scale (SMS)
The State Mindfulness Scale is a 5-point Likert scale with a minimum value of "1" (not at all) and a maximum value of "5" (very well). The State Mindfulness Scale measures how "mindfully" one performed a specific task or activity. Higher scores on the State Mindfulness Scale indicate one performed a task in a more mindful way.
Measured: Administered 15 minutes after the intervention for sessions 1 and 2
Secondary outcomes (3)
Intrinsic Motivation Inventory (IMI)
The Intrinsic Motivation Inventory is a 7-point Likert scale with a minimum value of "1" (not at all) and a maximum value of "7" (extremely true). The Intrinsic Motivation Inventory measures how much enjoyment and satisfaction one derives from engaging in a given activity. Higher scores on the Intrinsic Motivation Inventory indicate more satisfaction and enjoyment for the activity.
Measured: Administered 20 minutes after the intervention for sessions 1 and 2.
Flow State Scale (FSS)
The Flow State Scale is a 5-point Likert scale with a minimum value of "1" (strongly disagree) and a maximum value of "5" (strongly agree). The Flow State Scale measures how immersed one was while performing a task or activity. A higher score on the Flow State Scale indicates that one was more immersed and present during a specified activity.
Measured: Administered 25 minutes after the intervention for sessions 1 and 2.
Qualitative and Quantitative Feedback for Likelihood to Continue Activity in the Future (QQFLCA)
Qualitative and Quantitative Feedback for Likelihood to Continue Activity in the Future are open-ended text-response questions that asks participants for feedback to a variety of questions. The questions ask whether they found the study activity useful and/or important to them.
Measured: Administered 30 minutes after the intervention for sessions 1 and 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start20 Aug 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Depression MildStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2 x 2 study design with four groups. Half the participants will be randomized to a control condition and half will be randomized to an experimental condition (i.e., mindfulness). All participants will complete each of two study activities, but the order of the activities will be crossed over so that order effects for the activity are minimized. Thus, the groups will be as follows: Group 1: mindfulness condition and play video game first, fold laundry second Group 2: mindfulness condition and fold laundry first, play video game second Group 3: control condition and play video game first, fold laundry second Group 4: control condition and fold laundry first, play video game second
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald Davison, University of Southern California
- Investigators
- Gerald Davison, Ph.D., Study chair, Faculty PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551976
- Sponsor's protocol ID
- UP-20-00148
- Acronym
- GAMES
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson CA, Sakamoto A, Gentile DA, Ihori N, Shibuya A, Yukawa S, Naito M, Kobayashi K. Longitudinal effects of violent video games on aggression in Japan and the United States. Pediatrics. 2008 Nov;122(5):e1067-72. doi: 10.1542/peds.2008-1425.
PubMed 18977956Baer, R. A. (2003). Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical psychology: Science and practice, 10(2), 125-143.
Baer, R. A. (Ed.). (2015). Mindfulness-based treatment approaches: Clinician's guide to evidence base and applications. Elsevier.
Baranowski T, Buday R, Thompson DI, Baranowski J. Playing for real: video games and stories for health-related behavior change. Am J Prev Med. 2008 Jan;34(1):74-82. doi: 10.1016/j.amepre.2007.09.027.
PubMed 18083454Brown, K. W., Ryan, R. M., & Creswell, J. D. (2007). Mindfulness: Theoretical foundations and evidence for its salutary effects. Psychological inquiry, 18(4), 211-237.
Brown, K. W., Ryan, R. M., & Creswell, J. D. (2007). Addressing fundamental questions about mindfulness. Psychological Inquiry, 18(4), 272-281.
Gackenbach, J., & Bown, J. (2011). Mindfulness and video game play: A preliminary inquiry. Mindfulness, 2(2), 114-122.
Granic I, Lobel A, Engels RC. The benefits of playing video games. Am Psychol. 2014 Jan;69(1):66-78. doi: 10.1037/a0034857. Epub 2013 Dec 2.
PubMed 24295515Hanley, A. W., Warner, A. R., Dehili, V. M., Canto, A. I., & Garland, E. L. (2014). Washing dishes to wash the dishes: brief instruction in an informal mindfulness practice. Mindfulness, 6(5), 1095-1103.
Lippelt DP, Hommel B, Colzato LS. Focused attention, open monitoring and loving kindness meditation: effects on attention, conflict monitoring, and creativity - A review. Front Psychol. 2014 Sep 23;5:1083. doi: 10.3389/fpsyg.2014.01083. eCollection 2014.
PubMed 25295025Lomas, T., Cartwright, T., Edginton, T., & Ridge, D. (2015). A qualitative analysis of experiential challenges associated with meditation practice. Mindfulness, 6(4), 848-860.
Ryan RM, Deci EL. On happiness and human potentials: a review of research on hedonic and eudaimonic well-being. Annu Rev Psychol. 2001;52:141-66. doi: 10.1146/annurev.psych.52.1.141.
PubMed 11148302Sliwinski, J., Katsikitis, M., & Jones, C. M. (2015, September). Mindful gaming: How digital games can improve mindfulness. In IFIP Conference on Human-Computer Interaction (pp. 167-184). Springer, Cham.
Snodgrass JG, Lacy MG, Francois Dengah HJ 2nd, Fagan J, Most DE. Magical flight and monstrous stress: technologies of absorption and mental wellness in Azeroth. Cult Med Psychiatry. 2011 Mar;35(1):26-62. doi: 10.1007/s11013-010-9197-4.
PubMed 21165683Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
PubMed 10965637
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Habits of Gamers Study
- ClinicalTrials.gov ID
- NCT04551976
- Acronym / sponsor ID
- GAMES / UP-20-00148
- Keywords
- mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 2 x 2 study design with four groups. Half the participants will be randomized to a control condition and half will be randomized to an experimental condition (i.e., mindfulness). All participants will complete each of two study activities, but the order of the activities will be crossed over so that order effects for the activity are minimized. Thus, the groups will be as follows: Group 1: mindfulness condition and play video game first, fold laundry second Group 2: mindfulness condition and fold laundry first, play video game second Group 3: control condition and play video game first, fold laundry second Group 4: control condition and fold laundry first, play video game second
| Arm | Type | Receives |
|---|---|---|
| Mindful Video Game Then Laundry Group | Experimental | Behavioral: MindfulnessReceive mindfulness prompt and play their video game first and fold laundry second. |
| Mindful Laundry Then Video Game Group | Experimental | Behavioral: MindfulnessReceive mindfulness prompt and fold laundry first, play their video game second. |
| Control Video Game Then Laundry Group | No intervention | –Control condition that receives no mindfulness prompt and is asked to complete activities like they normally would. They will play their video game first and fold laundry second. |
| Control Laundry Then Video Game Group | No intervention | –Control condition that receives no mindfulness prompt and is asked to complete activities like they normally would. They will fold laundry first and will play their video game second. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-64
- "Gamer" = must play at least 3 and no more than 30 hours per week
- Must read and speak English
- Must have a private area, of the participant's choosing, in which to complete the two study sessions Must be able to speak with study personnel via Zoom
Key exclusion criteria (3 listed)
- "Gamer" = less than 3 hours of play per week, or more than 30 hours per week Prior experience with mindfulness in the form of
- "Formal Mindfulness Training". Formal mindfulness training is considered any class, group, or training that was done via individual group psychotherapy, with a licensed mental health professional.
- Be able to fluently read and speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessPay attention to the present moment, on purpose, in a nonjudgemental way. | Behavioural | Mindful Laundry Then Video Game Group, Mindful Video Game Then Laundry Group |
Primary outcome
Positive and Negative Affect Schedule (PANAS-X)
Time frame: Administered prior to the intervention to 10 minutes after the intervention for sessions 1 and 2.
The Positive and Negative Affect Schedule is a 5-point Likert scale with a minimum value of "1" (very slightly or not at all) and a maximum value of "5" (extremely). The Positive and Negative Affect Schedule measures participants' emotions/affect in the present moment. For this study the Positive and Negative Affect Schedule will be administered prior to and then immediately following a study activity and the change score from pre- to post-activity will constitute a primary outcome. Higher scores on the Positive and Negative Affect Schedule indicates more extreme emotional experiences.
State Mindfulness Scale (SMS)
Time frame: Administered 15 minutes after the intervention for sessions 1 and 2
The State Mindfulness Scale is a 5-point Likert scale with a minimum value of "1" (not at all) and a maximum value of "5" (very well). The State Mindfulness Scale measures how "mindfully" one performed a specific task or activity. Higher scores on the State Mindfulness Scale indicate one performed a task in a more mindful way.
3 secondary outcomes
Intrinsic Motivation Inventory (IMI)
Time frame: Administered 20 minutes after the intervention for sessions 1 and 2.
Flow State Scale (FSS)
Time frame: Administered 25 minutes after the intervention for sessions 1 and 2.
Qualitative and Quantitative Feedback for Likelihood to Continue Activity in the Future (QQFLCA)
Time frame: Administered 30 minutes after the intervention for sessions 1 and 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 18977956Anderson CA, Sakamoto A, Gentile DA, Ihori N, Shibuya A, Yukawa S, Naito M, Kobayashi K. Longitudinal effects of violent video games on aggression in Japan and the United States. Pediatrics. 2008 Nov;122(5):e1067-72. doi: 10.1542/peds.2008-1425.
- BackgroundBaer, R. A. (2003). Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical psychology: Science and practice, 10(2), 125-143.
- BackgroundBaer, R. A. (Ed.). (2015). Mindfulness-based treatment approaches: Clinician's guide to evidence base and applications. Elsevier.
- Background: PubMed 18083454Baranowski T, Buday R, Thompson DI, Baranowski J. Playing for real: video games and stories for health-related behavior change. Am J Prev Med. 2008 Jan;34(1):74-82. doi: 10.1016/j.amepre.2007.09.027.
- BackgroundBrown, K. W., Ryan, R. M., & Creswell, J. D. (2007). Mindfulness: Theoretical foundations and evidence for its salutary effects. Psychological inquiry, 18(4), 211-237.
- BackgroundBrown, K. W., Ryan, R. M., & Creswell, J. D. (2007). Addressing fundamental questions about mindfulness. Psychological Inquiry, 18(4), 272-281.
- BackgroundGackenbach, J., & Bown, J. (2011). Mindfulness and video game play: A preliminary inquiry. Mindfulness, 2(2), 114-122.
- Background: PubMed 24295515Granic I, Lobel A, Engels RC. The benefits of playing video games. Am Psychol. 2014 Jan;69(1):66-78. doi: 10.1037/a0034857. Epub 2013 Dec 2.
- BackgroundHanley, A. W., Warner, A. R., Dehili, V. M., Canto, A. I., & Garland, E. L. (2014). Washing dishes to wash the dishes: brief instruction in an informal mindfulness practice. Mindfulness, 6(5), 1095-1103.
- Background: PubMed 25295025Lippelt DP, Hommel B, Colzato LS. Focused attention, open monitoring and loving kindness meditation: effects on attention, conflict monitoring, and creativity - A review. Front Psychol. 2014 Sep 23;5:1083. doi: 10.3389/fpsyg.2014.01083. eCollection 2014.
- BackgroundLomas, T., Cartwright, T., Edginton, T., & Ridge, D. (2015). A qualitative analysis of experiential challenges associated with meditation practice. Mindfulness, 6(4), 848-860.
- Background: PubMed 11148302Ryan RM, Deci EL. On happiness and human potentials: a review of research on hedonic and eudaimonic well-being. Annu Rev Psychol. 2001;52:141-66. doi: 10.1146/annurev.psych.52.1.141.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Davison, Ph.D. study chair
Faculty PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Depression Mild and Depression, Anxiety, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Affect Schedule (PANAS-X) (time frame: Administered prior to the intervention to 10 minutes after the intervention for sessions 1 and 2.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551976, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.