Brief Smartphone Treatment Study

Official title

Brief Smartphone Treatment Study for Anxiety and Depression

Overview

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.

Interventions

• Device 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.
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Change from Baseline Depression Symptom Severity at 14-Day Post-Treatment [Time frame: Baseline to 14-Day Post-Treatment]
• Change from Baseline Depression Symptom Severity at 6-Week Post-Randomization [Time frame: Baseline to 6-Week Post-Randomization]
• Change from Baseline Attentional Control at 14-Day Post-Treatment [Time frame: Baseline to 14-Day Post-Treatment]
• Change from Baseline Attentional Control at 6-Week Post-Randomization [Time frame: Baseline to 6-Week Post-Randomization]
• Change from Baseline Working Memory at 14-Day Post-Treatment [Time frame: Baseline to 14-Day Post-Treatment]
• Change from Baseline Working Memory at 6-Week Post-Randomization [Time frame: Baseline to 6-Week Post-Randomization]
• Change from Baseline Set-Shifting at 14-Day Post-Treatment [Time frame: Baseline to 14-Day Post-Treatment]
• Change from Baseline Set-Shifting at 6-Week Post-Randomization [Time frame: Baseline to 6-Week Post-Randomization]
• Change from Baseline Inhibitory Control at 14-Day Post-Treatment [Time frame: Baseline to 14-Day Post-Treatment]
• Change from Baseline Inhibitory Control at 6-Week Post-Randomization [Time frame: Baseline to 6-Week Post-Randomization]
• Change from Baseline Verbal Fluency at 14-Day Post-Treatment [Time frame: Baseline to 14-Day Post-Treatment]
• Change from Baseline Verbal Fluency at 6-Week Post-Randomization [Time frame: Baseline to 6-Week Post-Randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• The Pennsylvania State University — University Park

Publications

• Zainal NH, Newman MG. Who engages? Machine learning insights into digital mindfulness-based intervention for generalized anxiety disorder. J Affect Disord. 2026 Apr 15;399:120963. doi: 10.1016/j.jad.2025.120963. Epub 2025 Dec 19. PMID 41422949
• Zainal NH, Newman MG. Examining the Effects of a Brief, Fully Self-Guided Mindfulness Ecological Momentary Intervention on Empathy and Theory-of-Mind for Generalized Anxiety Disorder: Randomized Controlled Trial. JMIR Ment Health. 2024 May 24;11:e54412. doi: 10.2196/54412. PMID 38787613

Identifiers

NCT: NCT04846777 · STUDY00010664

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗