The COMParing App Support Strategies Study
ConditionDepression, Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Wisconsin, Madison
About this trial
The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Elevated symptoms of depression and/or anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10)
Proficiency in English
Access to a smartphone and internet
Ability to receive text messages
Disqualifiers
Non-US citizen or legal resident (green card holder)
History of psychosis or mania
Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9
Individuals who do not provide the information required for GUID generation
Trial design
Design model
Parallel
Treatments tested in this trial
Introductory Coaching Session
Other interventionParticipant is randomized to receive a 30-minute meditation coaching session
Introductory Information Session
Other interventionParticipant is randomized to receive a 30-minute information session
On-Demand Email Support
Other interventionemail support throughout the 4 week intervention period
Microsupport
Other interventionText message microsupport throughout the 4 week intervention period
Treatment groups
688 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: CoachingExperimental treatment 1 intervention
Group B: Coaching with On-Demand email supportExperimental treatment 2 interventions
Group C: Coaching and microsupportExperimental treatment 2 interventions
Group D: Coaching with On-Demand email support and microsupportExperimental treatment 3 interventions
Group E: No additional supportNo intervention 0 interventions
Group F: On-Demand email supportExperimental treatment 2 interventions
Group G: MicrosupportExperimental treatment 2 interventions
Group H: On-Demand email support and microsupportExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) Score
The PHQ-ADS is scored by summing responses to its 16 items (combining the PHQ-9 and GAD-7), with scores ranging from 0 to 48, where higher scores indicate greater distress. Each item uses a 0-3 scale (0=Not at all, 3=Nearly every day). Common interpretation is 10 (mild), 20 (moderate), and 30 (severe) distress.
Time frame
baseline, week 1, week 2, week 3, week 4, 6-month follow up2
Anxiety Measured from Evening Daily Diary Items
Evening daily diary will include a single-item measure of anxiety using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate more severe anxiety. Daily means with and standard deviations will be reported.
Time frame
Daily through the Intervention Period (up to 4 weeks)3
Depression Measured from Evening Daily Diary Items
Evening daily diary will include a single-item measures of depression using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate more severe depression. Daily means with and standard deviations will be reported.
Time frame
Daily through the Intervention Period (up to 4 weeks)Secondary outcomes
1
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
A computer-adaptive measure of feelings of depression scored from 1 to 5 where higher numbers indicate increased feelings of depression. It provides t-scores with a mean of 50 and SD of 10
Time frame
baseline, week 1, week 2, week 3, week 4, 6-month follow up2
PROMIS Toolbox Meaning and Purpose Score
The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.
Time frame
baseline, week 1, week 2, week 3, week 4, 6-month follow up3
NIH Toolbox Loneliness Score
The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.
Time frame
baseline, week 1, week 2, week 3, week 4, 6-month follow up4
Beck's Depression Inventory (BDI) Item 9 Score
Item 9 on the Beck Depression Inventory (BDI) assesses suicidal thoughts or wishes. The possible scores for this item are 0, 1, 2, or 3, corresponding to different levels of severity. A score of 0 indicates no suicidal thoughts, while higher scores indicate increasing severity of suicidal ideation.
Time frame
baseline, week 1, week 2, week 3, week 4, 6-month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov