Brief Smartphone Treatment Study

Recruiting in Palo Alto (17 mi)

Overseen byNur Hani Zainal, M.S.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Penn State University

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nur Hani Zainal, M.S.

Principal Investigator

The Pennsylvania State University

Eligibility Criteria

Inclusion Criteria

I'm a current student at the Pennsylvania State University or a community-dwelling adult who expressed interest to participate in a research study through the PSU StudyFinder portal.

You are not currently seeing a mental health professional for treatment.

Presence of Generalized Anxiety Disorder based on the Generalized Anxiety Disorder Questionnaire-IV self-report and Mini International Neuropsychiatric Interview

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Exclusion Criteria

I'm sorry, it seems like the criterion got cut off. Could you please provide the complete criterion so I can summarize it for you?

Below age 18

Failure to meet any of above inclusion criteria

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Treatment Details

Interventions

Mindfulness ecological momentary intervention (Behavioural Intervention)
Self-monitoring placebo (Behavioural Intervention)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mindfulness ecological momentary interventionExperimental Treatment1 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 II: Self-monitoring placeboPlacebo Group1 Intervention