Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04846777

Brief Smartphone Treatment Study

Led by Penn State University · Updated on 2022-04-26

300

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 efficacy of unguided, technology-assisted, brief mindfulness in a clinical sample.

CONDITIONS

Official Title

Brief Smartphone Treatment Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of Generalized Anxiety Disorder based on the Generalized Anxiety Disorder Questionnaire-IV self-report and Mini International Neuropsychiatric Interview
  • Current student at the Pennsylvania State University or a community-dwelling adult who expressed interest to participate through the PSU StudyFinder portal
  • Expressed interest to seek treatment
  • Currently not receiving treatment from a mental health professional
  • Able to provide consent
  • Proficient in English
Not Eligible

You will not qualify if you...

  • Below age 18
  • Failure to meet any of the inclusion criteria
  • Participant currently undergoing any treatment from a mental health professional
  • Presence of suicidality, mania, psychosis, or substance use disorders

AI-Screening

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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.

CONTACT

M

Michelle G. Newman, Ph.D.

CONTACT

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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