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/41422949/Actively Recruiting
Led by Penn State University · Updated on 2022-04-26
300
Participants Needed
1
Research Sites
N/A
Total Duration
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 Smartphone Treatment Study
N
Nur Hani Zainal, M.S.
M
Michelle G. Newman, Ph.D.
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Penn State University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Smartphone‑delivered mindfulness ecological momentary intervention | Smartphone‑delivered self‑monitoring placebo | Guideline‑recommended CBT |
|---|---|---|---|
| What it is | A smartphone‑delivered mindfulness ecological momentary intervention prompting mindfulness skills five times daily. | A smartphone‑delivered self‑monitoring sham intervention prompting self‑monitoring five times daily. | Cognitive behavioral therapy is a guideline‑recommended first‑line psychological treatment for generalized anxiety disorder. |
| Role in trial | Investigational intervention being tested compared to control. | Placebo comparator arm that delivers self‑monitoring prompts without mindfulness strategies. | Current standard therapy to which research findings are often compared in clinical practice. |
| Primary purpose | Was tested to reduce generalized anxiety and repetitive worry via smartphone‑based mindfulness. | Served as a sham control to isolate the effect of mindfulness content from app use. | Typically used to reduce anxiety through structured therapy sessions focusing on thoughts and behaviors. |
| How it is delivered | Via smartphone app prompting mindfulness exercises at five preset times each day. | Via smartphone app prompting self‑monitoring activities at five preset times each day. | Delivered in structured therapy sessions by trained providers (usually in person or telehealth). |
| Evidence status | Early trial evidence—evaluating symptom and worry improvements at two and six weeks. | Used as control; not intended to provide anxiety relief beyond placebo effects. | Strong evidence supports CBT effectiveness in reducing GAD symptoms. |
| Important risks | Not established; trial safety data pending. | Not established; trial safety data pending. | Generally well‑tolerated; some individuals may experience temporary emotional discomfort during therapy. |
| Important limitations | Effectiveness and long‑term impact remain uncertain pending trial results; digital access may limit participation. | Designed as placebo; lacks therapeutic components and not intended for clinical benefit. | Requires trained therapists and multiple sessions, which may limit accessibility. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nur Hani Zainal, Michelle G Newman
https://pubmed.ncbi.nlm.nih.gov/41422949/Nur Hani Zainal, Michelle G Newman
https://pubmed.ncbi.nlm.nih.gov/38787613/Penn State University
Lead Sponsor