Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04551976
Other study ID # UP-20-00148
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 20, 2020
Est. completion date January 1, 2021

Study information

Verified date September 2021
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Department of Psychology; University of Southern California, Seely G Mudd Building Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (15)

See more »

Outcome

Type Measure Description Time frame Safety issue
Other Acceptability of mindfulness (AoM) Acceptability of mindfulness is a multiple choice question that asks participants how easy or difficult they found mindfulness to be, as well as whether it was easier to practice with a video game or via laundry folding. The scale has response options of "video game play," "folding laundry," "both," and "neither." Administered 45 minutes after the intervention for sessions 1 and 2.
Other Semantic Differentiation Scale for Ease of Learning (SDS-EL) The Semantic Differentiation Scale for Ease of Learning is a semantic differentiation scale with a given a set of word anchors (i.e., happy versus unhappy, pleased versus annoyed, hopeful versus despairing, etc.) that have 7 selection options in between the two words. Participants are asked to place a mark on one of the 7 selection options according to which word better represents how they feel. For data analysis purposes the three selection options closer to a negative word (i.e., unhappy, annoyed, despairing) will be scored -1, -2, and -3 with -3 representing an extreme negative feeling. The three selection options closer to a positive word (i.e., happy, pleased, hopeful) will be scored 1, 2, and 3 with a 3 representing an extreme positive feeling. Selecting a mark in the middle will be scored 0 for neutral. The scale will measure the extent to which participants found the intervention (i.e., mindfulness) to be easy to learn and apply to the study activity. Administered 35 minutes after the intervention for sessions 1 and 2.
Primary 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.
Primary 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 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. Administered 20 minutes after the intervention for sessions 1 and 2.
Secondary 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. Administered 25 minutes after the intervention for sessions 1 and 2.
Secondary 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. Administered 30 minutes after the intervention for sessions 1 and 2.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A