Mindfulness Training and Respiration Biosignal Feedback - Study 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorEqua Health
About this trial
The goal of this research is to test usability and user satisfaction with a new breathing feature on the meditation app, Equa, to help young adults who are distressed, understand their physiological responses and mindfulness skill development during meditation.
Our main aims are to test an algorithm that can use physiologic signals to give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa through:
* Assessing user satisfaction and usability * Measuring how much participant mindfulness skills are improving
Participants will:
* Complete a survey about demographics, their thoughts and feelings before and after the mindfulness meditation program * Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded * A subset of participants will see a graph tracking their physiological responses from the guided meditation lesson and predictive mindfulness skill scores * Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-30 years of Age
Fluent in English
Psychological distress
Willing to participate in guided meditation or stress management training.
Disqualifiers
Currently pregnant
Current or previous diagnosis with psychosis or schizophrenia
Trial design
Design model
Sequential
Treatments tested in this trial
Mindfulness Meditation
BehavioralParticipants will be randomly assigned to one of two different 14-unit smartphone meditation program groups that involve completing a 2-10 minute daily guided practice on their phones. Participants in both groups will follow the same 14 units of mindfulness meditation curriculum that consists of learning and practicing techniques to improve concentration, sensory clarity, and equanimity (Equa meditation app) and have access to additional curriculum. Physiological measures will be tracked throughout the duration of lessons. The control group will not see the graph tracking their physiological responses or the predictive mindfulness skill scores based on the algorithm development.
Mindfulness Meditation with Respiration Feedback Chart and Predictive Mindfulness Skill Scores
BehavioralParticipants will then be randomly assigned to one of two different 14-unit smartphone meditation program groups that involve completing a 2-10 minute daily guided practice on their phones. Participants in both groups will follow the same 14 units of mindfulness meditation curriculum that consists of learning and practicing techniques to improve concentration, sensory clarity, and equanimity (Equa meditation app) and have access to additional curriculum. Physiological measures will be tracked throughout the duration of lessons. Following the guided meditation lessons, a subset of participants (the experimental group) will see a graph tracking their physiological responses from the guided meditation lesson and predictive mindfulness skill scores based on our algorithm development. The feedback chart is produced by the physiological measures tracked throughout the duration of the lesson, and is displayed within the Equa app, moments after the meditation lessons concludes.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control Group, No Physiological FeedbackActive comparator 1 intervention
Group B: Experimental Group, Physiological FeedbackExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assess usability and user satisfaction with respiration biosignal tracking and predictive mindfulness skill scores during meditation training to changes in mindfulness skills from pre-training to post-training
\>85 on System Usability Scale and significantly more user satisfaction with biosignal augmented Equa. The investigators will conduct usability testing with the respiration biosignal tracking on Equa, and experimentally evaluate if Equa-augmented respiration biosignal tracking increases user satisfaction in the lab relative to Equa with no biosignal tracking.
Time frame
Throughout 5 sessions over the course of 4 weeks (study completion)Secondary outcomes
1
Change from Baseline in total anxiety as assessed by the General Anxiety Disorder, 7-item questionnaire at post treatment
Participants respond to a questionnaire asking about how often they have been bothered by any of the listed problems over the last 2 weeks. Zero is equivalent to not at all (lower anxiety) and 3 indicates nearly every day (higher anxiety).
Time frame
From enrollment to the end of treatment at up to week 42
Change from Baseline in total depression as assessed by the Patient Health Questionnaire-9 at post treatment
Participants respond to a questionnaire asking about how often they have been bothered by any of the listed problems over the last 2 weeks related to the severity of depression symptomology. Zero is equivalent to not at all (lower depression) and 3 indicates nearly every day (higher depression)
Time frame
From enrollment to the end of treatment at up to week 43
Change from Baseline in total affect as assessed by the Positive and Negative Affect Scale at post treatment
Participants respond to a questionnaire asking to indicate the extent they have felt the following ways over the past 2 weeks related to their feelings and emotions. One is equivalent to not at all and five indicates extremely. The scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19 are added. Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. The scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20 are added. Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Time frame
From enrollment to the end of treatment at up to week 44
Change from Baseline in mean state mindfulness as assessed by the Mindful Attention Awareness Scale - state at post treatment
Participants respond to a questionnaire asking to what degree they were having each experience described over the past 2 weeks related to mindfulness practices. Zero is equivalent to not at all and six indicates very much. A mean score of the 15 items is taken, a higher score indicates greater mindfulness and a lower score indicates lower mindfulness.
Time frame
From enrollment to the end of treatment at up to week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Equa Health
Lead sponsor
Worcester Polytechnic Institute
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov