Clinical trial NCT04846777: Brief Smartphone Treatment Study
Official title: Brief Smartphone Treatment Study for Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Ecological momentary intervention
Mindfulness
Self-help
Digital health
Mobile app
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline Generalized Anxiety Disorder Symptoms at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Generalized Anxiety Disorder Symptoms at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Perseverative Cognitions at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Perseverative Cognitions at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
Secondary outcomes:
measure: Change from Baseline Depression Symptom Severity at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Depression Symptom Severity at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Attentional Control at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Attentional Control at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Working Memory at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Working Memory at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Set-Shifting at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Set-Shifting at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Inhibitory Control at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Inhibitory Control at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Verbal Fluency at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Verbal Fluency at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Empathy at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Empathy at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Interpersonal Reactivity Traits at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Interpersonal Reactivity Traits at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
measure: Change from Baseline Trait Mindfulness at 14-Day Post-Treatment
timeFrame: Baseline to 14-Day Post-Treatment
measure: Change from Baseline Trait Mindfulness at 6-Week Post-Randomization
timeFrame: Baseline to 6-Week Post-Randomization
Other outcomes:
measure: Mental health disorder screening measures
timeFrame: Baseline
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Nur Hani Zainal, M.S.
role: PRINCIPAL_INVESTIGATOR
References: