Clinical trial NCT05810259: Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life
Official title: Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life Via a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wellness
Quality of Life
Anxiety
Depression
Keywords: digital wellness interventions
wellness
mental health
mindfulness
exercise
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Caravan Wellness
First posted: 2023-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will examine the role of digital wellness modules (brief mindfulness and light to moderate physical exercise) delivered through a smartphone wellness application and their short-term effects on health behavior motivation and change, and longer-term quality of life and non-pathological affective states.

Detailed description: Primary Objective: The primary objective of this parallel-assignment longitudinal study is to determine whether the digital wellness modules (e.g., mindfulness and light to moderate physical activity) increase quality of life and decrease stress, anxiety, and depression, as mediated by health behavior motivation and change in a healthy population of adults. Secondary Objective(s): The secondary objective is to ascertain qualitatively through deductive thematic analysis specific themes of a) key drivers of health behavior change; b) types of motivations that drive health behavior change, and c) implementation of sustained health behavior change.

The study will be conducted virtually by Yale University researchers.

Eligibility criteria: Inclusion Criteria:

* Resides in United States

Exclusion Criteria:

* Any individual who endorses any of the following criteria will be excluded from participation in this study:
* Positive Health Screening Questions, as measured by the Health Screening Questionnaire (HSQ):

  * Pain, discomfort or pressure in the chest, difficulty breathing or shortness of breath, dizziness, fainting, or blackout, blood pressure with systolic greater than 140 or diastolic greater than 90, diagnosed or treated for any heart disease, heart murmur, chest pain (angina), palpitations (irregular beat), or heart attack, heart surgery, angioplasty, or a pacemaker, valve replacement, or heart transplant, resting pulse greater than 100 beats per minute, any arthritis, back trouble, hip /knee/joint /pain, or any other bone or joint condition, personal experience or doctor's advice of any other medical or physical reason that would prohibit the participant from doing light to moderate physical exercise, personal physician's recommendation against participating in light to moderate physical exercise because of asthma, diabetes, epilepsy or elevated cholesterol or a hernia.
* Positive Psychiatric Disorders Screening Questions:

  * Positive screen for depression, excluding suicide (PHQ-8) cutoff score \> 6
  * Positive screen for panic (SMPD) cutoff score \> 2
  * Positive screen for generalized anxiety (GAD-7) cutoff score \> 10
  * Positive screen psychosis (PDSQ) via psychosis section, cutoff score \> 3
  * Positive screen mania via the Altman Self-Rating Mania Scale (ASRM) cutoff score \> 6

Primary outcomes:
measure: Change in Mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: baseline, 1 Month follow up, 3 Month follow up
measure: Change in Exercise Behavior assessed by the Behavior Regulation Exercise Questionnaire, Third Version (BREQ-3)
timeFrame: baseline, 1 Month follow up, 3 Month follow up
measure: Utility of the Modules assessed by self report
timeFrame: up to Day 22
measure: Daily stressors assessed using the Brief Daily Stressors Screening Tool (BDSST)
timeFrame: up to Day 22
measure: Average number of minutes spent on Intervention
timeFrame: up to Day 22
measure: Change in health behavior motivation assessed using the Health Behavior Motivation Scale (HBMS)
timeFrame: baseline, 1 Month follow up, 3 Month follow up
measure: CHange in health behavior assessed using he Health Behavior Inventory-20 (HBI-20).
timeFrame: baseline, 1 Month follow up, 3 Month follow up
measure: Quality of life assessed using the Quality of Life Inventory (QOLI)
timeFrame: baseline, 1 Month follow up, 3 Month follow up
measure: Change in stress and non-pathological anxiety and depression assessed using the Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: baseline, 1 Month follow up, 3 Month follow up
Secondary outcomes:
measure: Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, 1 Month follow up, 3 Month follow up
measure: Physical activity assessed using the International Physical Activity Questionnaire, Long Form (IPAQ-LF).
timeFrame: up to Day 22
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: David Klemanski, Psy.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: