NCT04551976

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

September 1, 2020

Last Update Submit

September 30, 2021

Conditions

Keywords

mindfulness

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Administered 15 minutes after the intervention for sessions 1 and 2

Secondary Outcomes (3)

  • Intrinsic Motivation Inventory (IMI)

    Administered 20 minutes after the intervention for sessions 1 and 2.

  • Flow State Scale (FSS)

    Administered 25 minutes after the intervention for sessions 1 and 2.

  • Qualitative and Quantitative Feedback for Likelihood to Continue Activity in the Future (QQFLCA)

    Administered 30 minutes after the intervention for sessions 1 and 2.

Other Outcomes (2)

  • Acceptability of mindfulness (AoM)

    Administered 45 minutes after the intervention for sessions 1 and 2.

  • Semantic Differentiation Scale for Ease of Learning (SDS-EL)

    Administered 35 minutes after the intervention for sessions 1 and 2.

Study Arms (4)

Mindful Video Game Then Laundry Group

EXPERIMENTAL

Receive mindfulness prompt and play their video game first and fold laundry second.

Behavioral: Mindfulness

Mindful Laundry Then Video Game Group

EXPERIMENTAL

Receive mindfulness prompt and fold laundry first, play their video game second.

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.

Interventions

MindfulnessBEHAVIORAL

Pay attention to the present moment, on purpose, in a nonjudgemental way.

Mindful Laundry Then Video Game GroupMindful Video Game Then Laundry Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • "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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology; University of Southern California, Seely G Mudd Building

Los Angeles, California, 90089, United States

Location

Related Publications (15)

  • 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.

    PMID: 18977956BACKGROUND
  • Baer, R. A. (2003). Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical psychology: Science and practice, 10(2), 125-143.

    BACKGROUND
  • Baer, R. A. (Ed.). (2015). Mindfulness-based treatment approaches: Clinician's guide to evidence base and applications. Elsevier.

    BACKGROUND
  • 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.

    PMID: 18083454BACKGROUND
  • Brown, K. W., Ryan, R. M., & Creswell, J. D. (2007). Mindfulness: Theoretical foundations and evidence for its salutary effects. Psychological inquiry, 18(4), 211-237.

    BACKGROUND
  • Brown, K. W., Ryan, R. M., & Creswell, J. D. (2007). Addressing fundamental questions about mindfulness. Psychological Inquiry, 18(4), 272-281.

    BACKGROUND
  • Gackenbach, J., & Bown, J. (2011). Mindfulness and video game play: A preliminary inquiry. Mindfulness, 2(2), 114-122.

    BACKGROUND
  • 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.

    PMID: 24295515BACKGROUND
  • Hanley, 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
  • 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.

    PMID: 25295025BACKGROUND
  • Lomas, T., Cartwright, T., Edginton, T., & Ridge, D. (2015). A qualitative analysis of experiential challenges associated with meditation practice. Mindfulness, 6(4), 848-860.

    BACKGROUND
  • 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.

    PMID: 11148302BACKGROUND
  • Sliwinski, 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.

    BACKGROUND
  • 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.

    PMID: 21165683BACKGROUND
  • Teasdale 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.

    PMID: 10965637BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gerald Davison, Ph.D.

    Faculty PI

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in the control condition are told that we are interested in better understanding the behavioral habits of gamers. We ask them to complete the tasks as they normally would. Every participant will be debriefed after the final study session has concluded.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 16, 2020

Study Start

August 20, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations