Brief Smartphone Treatment Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness ecological momentary intervention

Intervention Type DEVICE

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

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.

Group Type PLACEBO_COMPARATOR

Self-monitoring placebo

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

* Participant currently undergoing
* Presence of suicidality, mania, psychosis, or substance use disorders