Who engages? Machine learning insights into digital mindfulness-based intervention for generalized anxiety disorder.
Nur Hani Zainal, Michelle G Newman
https://pubmed.ncbi.nlm.nih.gov/41422949Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04846777
Brief Smartphone Treatment Study for Anxiety and Depression
Led by Penn State University · Updated on 2022-04-26
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether a brief, smartphone-based mindfulness program can help adults with generalized anxiety disorder (GAD). This randomized controlled trial compares a 14-day mindfulness ecological momentary intervention (MEMI) with a self-monitoring placebo (SMP) to see if mindfulness training improves anxiety symptoms, attentional control, executive functioning, empathy, and perspective-taking. The study aims to fill gaps in knowledge about the benefits of short mindfulness therapies delivered via smartphone apps in people with GAD. Participants will be randomly assigned to either the MEMI group or the SMP group. Those in the MEMI group will receive prompts five times a day through a smartphone app to practice mindfulness skills such as open monitoring, acceptance, noticing small moments, and diaphragmatic breathing, plus bedtime reminders about mindfulness as a lifelong practice. The SMP group will also receive five daily prompts but will only practice self-monitoring of thoughts and feelings without mindfulness instructions. The intervention lasts for 14 consecutive days. Participants will complete self-report questionnaires and neuropsychological tests before treatment, after the 14-day intervention, and at a one-month follow-up. Researchers will measure changes in anxiety symptoms, perseverative thoughts, attentional control, working memory, set-shifting, inhibitory control, verbal fluency, empathy, interpersonal reactivity, and trait mindfulness. The study will use these assessments to evaluate the impact of the mindfulness intervention compared to self-monitoring over time.
CONDITIONS
Brief Title
Brief Smartphone Treatment Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Presence of Generalized Anxiety Disorder confirmed by self-report and clinical interview
- Current student at Pennsylvania State University or community adult interested through PSU StudyFinder
- Interest in seeking treatment
- Not currently receiving mental health professional treatment
- Able to provide consent
- Proficient in English
You will not qualify if you...
- Under 18 years old
- Not meeting inclusion criteria
- Currently undergoing mental health treatment
- Presence of suicidality, mania, psychosis, or substance use disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 days
Participants use a smartphone app delivering either a mindfulness ecological momentary intervention or a self-monitoring placebo, prompted 5 times daily to practice assigned skills.
Daily app interactions throughout treatment
Follow-up
Duration - Up to 6 weeks after treatment start
Participants are assessed for changes in anxiety, depression, and cognitive measures after completing the smartphone intervention.
1 follow-up visit at 6 weeks post-randomization
Trial Site Locations
Total: 1 location
1
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Actively Recruiting
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Research Team
N
Nur Hani Zainal, M.S.
M
Michelle G. Newman, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Examining the Effects of a Brief, Fully Self-Guided Mindfulness Ecological Momentary Intervention on Empathy and Theory-of-Mind for Generalized Anxiety Disorder: Randomized Controlled Trial.
Nur Hani Zainal, Michelle G Newman
https://pubmed.ncbi.nlm.nih.gov/38787613