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NCT04846777 · ClinicalTrials.gov registry record · NA
Brief Smartphone Treatment Study
A NA study of Generalized Anxiety Disorder, sponsored by Penn State University.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT04846777 is a NA study of Generalized Anxiety Disorder that is actively recruiting participants, run by Penn State University. The registered enrollment target is 300 participants, above the 209-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (44% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04846777, a NA study of Generalized Anxiety Disorder, is actively recruiting participants, sponsored by Penn State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
Little is known about whether and how brief mindfulness therapies yield clinically beneficial effects. This gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap. Specifically, no prior brief, smartphone mindfulness ecological momentary intervention (MEMI) has targeted generalized anxiety disorder (GAD). Moreover, although theories propose that mindfulness intervention can boost attentional control (AC), executive functioning (EF), perspective-taking, and social cognition skills they have largely gone untested. Thus, this randomized controlled trial (RCT) aims to address these gaps by assessing the efficacy of a 14-day smartphone mindfulness EMI (vs. placebo). Participants with GAD will be randomly assigned to either MEMI or self-monitoring placebo (SMP). Those in treatment will exercise multiple core mindfulness strategies (open monitoring, acceptance, attending to small moments, slowed rhythmic diaphragmatic breathing). Also, those in MEMI will be reminded before bedtime that mindfulness is a lifelong practice. Comparatively, participants assigned to SMP will only be prompted to practice self-monitoring. They will notice their thoughts, rate any distress associated with them, and will not be taught any mindfulness strategies. All prompts will occur 5 times a day, for 14 consecutive days. They will complete self-reports and neuropsychological assessments at pre-, post-, and 1-month follow-up. Multilevel modeling analyses will determine if treatment (vs. self-monitoring placebo (SMP)) produces substantially larger reductions in trait worry and negative perseverative cognitions as well as steeper increases in AC and EF (inhibition, set-shifting, working memory updating). In addition, the investigators hypothesized that MEMI (vs. SMP) would lead to greater increases in performance-based and self-reported trait mindfulness, empathy, and perspective taking. Findings will advance understanding of the effica
Conditions Studied
Interventions
- DEVICE Mindfulness ecological momentary intervention
- DEVICE Self-monitoring placebo
Study Locations (1)
Pennsylvania
- The Pennsylvania State University - University Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2023-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04846777
The ClinicalTrials.gov registry entry for NCT04846777 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 209-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (44% higher). The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Generalized Anxiety Disorder appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness ecological momentary intervention is the first listed.
NCT04846777 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04846777 about?
NCT04846777 is a clinical study titled "Brief Smartphone Treatment Study". Little is known about whether and how brief mindfulness therapies yield clinically beneficial effects. This gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap. Specifically, no prior brief, smartphone mindfulness ecological momentar...
What is the current status of trial NCT04846777?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2018-11-14. Estimated completion is 2023-07-31.
What conditions does trial NCT04846777 study?
This clinical trial studies the following conditions: Generalized Anxiety Disorder.
What interventions are being tested in trial NCT04846777?
The interventions under investigation include: Mindfulness ecological momentary intervention (DEVICE), Self-monitoring placebo (DEVICE).
Who is sponsoring clinical trial NCT04846777?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04846777 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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