Brief Smartphone Treatment Study

NCT04846777 | Recruiting FDA Device

• 1 other identifier: STUDY00010664
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change from Baseline Generalized Anxiety Disorder Symptoms at 14-Day Post-Treatment

  Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) with categorical ('Yes' for presence and 'No' for absence) and continuous response formats (0 = not at all to 8 = very severely) (Newman et al., 2002) (Item 1 to Item 14 self-report; possible range = 0-12). Generalized Anxiety Disorder Questionnaire-Dimensional (Item 15 to Item 30) with consistent continuous 8-point Likert scale response formats that measures the frequency, intensity, uncontrollability, and degree of excessive worry (e.g., 0 = Always in control to 8 = Never in control) (Newman et al.) (possible range = 0-128). Larger reduction in score denote better outcome.

  Baseline to 14-Day Post-Treatment

• Change from Baseline Generalized Anxiety Disorder Symptoms at 6-Week Post-Randomization

  Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) with categorical ('Yes' for presence and 'No' for absence) and continuous response formats (0 = not at all to 8 = very severely) (Newman et al., 2002) (Item 1 to Item 14 self-report; possible range = 0-12). Generalized Anxiety Disorder Questionnaire-Dimensional (Item 15 to Item 30) with consistent continuous 8-point Likert scale response formats that measures the frequency, intensity, uncontrollability, and degree of excessive worry (e.g., 0 = Always in control to 8 = Never in control) (Newman et al.) (possible range = 0-128). Larger reduction in score denote better outcome.

  Baseline to 6-Week Post-Randomization

• Change from Baseline Perseverative Cognitions at 14-Day Post-Treatment

  The 45-item PCQ assessed perseverative cognitive traits linked to anxiety, depressive, and obsessive-compulsive symptoms. Respondents endorsed on a 6-point Likert scale (0 = strongly disagree to 5 = strongly agree). Further, the PCQ-45 comprised six factors: dwelling on the past; expecting the worst; lack of controllability; thoughts discrepant with ideal self; preparing for the future; searching for causes and meanings. Additionally, the PCQ had strong two-week retest reliability, discriminant validity, and convergent validity (Szkodny \& Newman, 2019). A total score for PCQ was computed by summing the mean scores from each subscale (total possible score = 0-30). Larger reduction in score denote better outcome.

  Baseline to 14-Day Post-Treatment

• Change from Baseline Perseverative Cognitions at 6-Week Post-Randomization

  The 45-item PCQ assessed perseverative cognitive traits linked to anxiety, depressive, and obsessive-compulsive symptoms. Respondents endorsed on a 6-point Likert scale (0 = strongly disagree to 5 = strongly agree). Further, the PCQ-45 comprised six factors: dwelling on the past; expecting the worst; lack of controllability; thoughts discrepant with ideal self; preparing for the future; searching for causes and meanings. Additionally, the PCQ had strong two-week retest reliability, discriminant validity, and convergent validity (Szkodny \& Newman, 2019). A total score for PCQ was computed by summing the mean scores from each subscale (total possible score = 0-30). Larger reduction in score denote better outcome.

  Baseline to 6-Week Post-Randomization

Secondary Outcomes (18)

• Change from Baseline Depression Symptom Severity at 14-Day Post-Treatment

  Baseline to 14-Day Post-Treatment

• Change from Baseline Depression Symptom Severity at 6-Week Post-Randomization

  Baseline to 6-Week Post-Randomization

• Change from Baseline Attentional Control at 14-Day Post-Treatment

  Baseline to 14-Day Post-Treatment

• Change from Baseline Attentional Control at 6-Week Post-Randomization

  Baseline to 6-Week Post-Randomization

• Change from Baseline Working Memory at 14-Day Post-Treatment

  Baseline to 14-Day Post-Treatment

Other Outcomes (1)

• Mental health disorder screening measures

  Baseline

Study Arms (2)

Mindfulness ecological momentary intervention

EXPERIMENTAL

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.

Device: Mindfulness ecological momentary intervention

Self-monitoring placebo

PLACEBO COMPARATOR

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.

Device: Self-monitoring placebo

Interventions

Mindfulness ecological momentary intervention 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.

Mindfulness ecological momentary intervention

Self-monitoring placebo 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.

Self-monitoring placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Below age 18
• Participant currently undergoing
• Presence of suicidality, mania, psychosis, or substance use disorders

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

RECRUITING

Related Publications (2)

• Zainal NH, Newman MG. Who engages? Machine learning insights into digital mindfulness-based intervention for generalized anxiety disorder. J Affect Disord. 2025 Dec 19;399:120963. doi: 10.1016/j.jad.2025.120963. Online ahead of print.

  PMID: 41422949 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Nur Hani Zainal, M.S.

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nur Hani Zainal, M.S.

CONTACT

917-767-7088; nvz5057@psu.edu

Michelle G. Newman, Ph.D.

CONTACT

814-883-4572; mgn1@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 15, 2021
• Study Start: November 14, 2018
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)