Recruiting

Smartphone Treatment

Sponsor:

Penn State University

Code:

NCT04846777

Conditions

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness ecological momentary intervention

Self-monitoring placebo

Study Details

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

Conditions

Generalized Anxiety Disorder

Study ID

NCT04846777

Start date

Nov 14, 2018

Status verified date

Apr, 2022

Completion date

Jul 31, 2023

Anticipated

Primary completion date

Jul 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Below age 18
  • Failure to meet any of above inclusion criteria
  • Participant currently undergoing
  • Presence of suicidality, mania, psychosis, or substance use disorders

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness ecological momentary intervention

The SMP condition was developed to parallel the treatment while eliminating its theorized active therapeutic elements - open monitoring, acceptance, attending to small moments, breathing retraining, continual practice of mindfulness. Therefore, it did not mention anything about mindfulness at all. Instead, SMP participants were instructed to notice their cognitions and emotions and how distress they might be. No instruction on accepting their thoughts and feelings as they are were given.

placebo comparator: Self-monitoring placebo

The SMP condition was developed to parallel the treatment while eliminating its theorized active therapeutic elements - open monitoring, acceptance, attending to small moments, breathing retraining, continual practice of mindfulness. Therefore, it did not mention anything about mindfulness at all. Instead, SMP participants were instructed to notice their cognitions and emotions and how distress they might be. No instruction on accepting their thoughts and feelings as they are were given.

Interventions

Mindfulness ecological momentary intervention

Access to a smartphone-delivered mindfulness ecological momentary intervention with the Personal Analytics Companion (PACO) app that regularly prompts participants to practice various mindfulness skills at 5 preset times each day.

Self-monitoring placebo

Access to a smartphone-delivered self-monitoring placebo with the PACO app that regularly prompts participants to practice self-monitoring at 5 preset times each day.

Primary outcome measure

  • Change from Baseline Generalized Anxiety Disorder Symptoms at 14-Day Post-Treatment [ Time Frame: Baseline to 14-Day Post-Treatment ]
  • Change from Baseline Generalized Anxiety Disorder Symptoms at 6-Week Post-Randomization [ Time Frame: Baseline to 6-Week Post-Randomization ]
  • Change from Baseline Perseverative Cognitions at 14-Day Post-Treatment [ Time Frame: Baseline to 14-Day Post-Treatment ]
  • Change from Baseline Perseverative Cognitions at 6-Week Post-Randomization [ Time Frame: Baseline to 6-Week Post-Randomization ]

Central Contacts and Locations

Central contacts

Nur Hani Zainal, M.S.

917-767-7088nvz5057@psu.edu

Michelle G. Newman, Ph.D.

814-883-4572mgn1@psu.edu

Locations

The Pennsylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

Nur Hani Zainal, M.S.

917-767-7088nvz5057@psu.edu

Michelle G. Newman, Ph.D.

814-883-4572mgn1@psu.edu

Principal Investigator:

Nur Hani Zainal, M.S.

More Information

Sponsor

Penn State University

Last update posted

Apr 26, 2022

Last verified

Apr, 2022

Keywords

  • Ecological momentary intervention
  • Mindfulness
  • Self-help
  • Digital health
  • Mobile app

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2022-04-26.