Brief Smartphone Treatment Study

Brief Smartphone Treatment Study for Anxiety and Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Device: Mindfulness ecological momentary intervention; Device: Self-monitoring placebo

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nur Hani Zainal, M.S.; Phone Number: 917-767-7088; Email: nvz5057@psu.edu
• Study Contact Backup: Name: Michelle G. Newman, Ph.D.; Phone Number: 814-883-4572; Email: mgn1@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Recruiting
      • The Pennsylvania State University
      • Contact: Nur Hani Zainal, M.S.; Phone Number: 917-767-7088; Email: nvz5057@psu.edu
      • Contact: Michelle G. Newman, Ph.D.; Phone Number: 814-883-4572; Email: mgn1@psu.edu
      • Principal Investigator: Nur Hani Zainal, M.S.
      • Sub-Investigator: Michelle G. Newman, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Depression Symptom Severity at 14-Day Post-Treatment	Beck Depression Inventory (Beck, Steer, & Brown, 1996) (21 of 21 items; self-report; possible range = 0-63). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Depression Symptom Severity at 6-Week Post-Randomization	Beck Depression Inventory (Beck, Steer, & Brown, 1996) (21 of 21 items; self-report; possible range = 0-63). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Change from Baseline Attentional Control at 14-Day Post-Treatment	Attentional Control Questionnaire (Derryberry & Reed, 2002) (21 of 21 items; self-report; possible range = 0-60). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Attentional Control at 6-Week Post-Randomization	Attentional Control Questionnaire (Derryberry & Reed, 2002) (21 of 21 items; self-report; possible range = 0-60). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Change from Baseline Working Memory at 14-Day Post-Treatment	Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV; Wechsler, 2008) (21 of 21 items; self-report; possible range = 0-78). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Working Memory at 6-Week Post-Randomization	Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV; Wechsler, 2008) (21 of 21 items; self-report; possible range = 0-78). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization
Change from Baseline Set-Shifting at 14-Day Post-Treatment	Trail Making Test Part A and Part B (TMT-A and B; Strauss, Sherman, & Spreen, 2006) (2 of 2 items; self-report; possible range = 0-480). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Set-Shifting at 6-Week Post-Randomization	Trail Making Test Part A and Part B (TMT-A and B; Strauss, Sherman, & Spreen, 2006) (2 of 2 items; self-report; possible range = 0-480). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Change from Baseline Inhibitory Control at 14-Day Post-Treatment	Color-Word Interference Test response time (Delis, Kaplan, & Kramer, 2001) (1 of 4 items; self-report; possible range = 0-960). Larger reduction in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Inhibitory Control at 6-Week Post-Randomization	Color-Word Interference Test response time (Delis, Kaplan, & Kramer, 2001) (1 of 4 items; self-report; possible range = 0-960). Larger reduction in score denote better outcome.	Baseline to 6-Week Post-Randomization
Change from Baseline Verbal Fluency at 14-Day Post-Treatment	Phonemic cue; category fluency; switching fluency (Delis, Kaplan, & Kramer, 2001) (3 of 3 items; self-report; possible range = 0-240). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Verbal Fluency at 6-Week Post-Randomization	Phonemic cue; category fluency; switching fluency (Delis, Kaplan, & Kramer, 2001) (3 of 3 items; self-report; possible range = 0-240). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization
Change from Baseline Empathy at 14-Day Post-Treatment	Bell-Lysaker Emotion Recognition Test (BLERT; Bryson, Bell, & Lysaker, 1997) (21 of 21 items; self-report; possible range = 0-21). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Empathy at 6-Week Post-Randomization	Bell-Lysaker Emotion Recognition Test (BLERT; Bryson, Bell, & Lysaker, 1997) (21 of 21 items; self-report; possible range = 0-21). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization
Change from Baseline Interpersonal Reactivity Traits at 14-Day Post-Treatment	Interpersonal Reactivity Index (IRI; Davis, 1980) (28 of 28 items; self-report; possible range = 0-140). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Interpersonal Reactivity Traits at 6-Week Post-Randomization	Interpersonal Reactivity Index (IRI; Davis, 1980) (28 of 28 items; self-report; possible range = 0-140). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization
Change from Baseline Trait Mindfulness at 14-Day Post-Treatment	Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2008) (28 of 28 items; self-report; possible range = 0-395). Larger increase in score denote better outcome.	Baseline to 14-Day Post-Treatment
Change from Baseline Trait Mindfulness at 6-Week Post-Randomization	Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2008) (28 of 28 items; self-report; possible range = 0-395). Larger increase in score denote better outcome.	Baseline to 6-Week Post-Randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health disorder screening measures	Generalized anxiety disorder assessed using the Generalized Anxiety Disorder Questionnaire-IV (possible score range = 0 to 14). Higher score indicate worse outcome. Mental health disorders (generalized anxiety disorder, generalized anxiety disorder, major depressive disorder, manic and hypomanic episodes, agoraphobia, panic disorder, post-traumatic stress disorder, alcohol use disorder, substance use disorder, anorexia nervosa, bulimia nervosa, binge eating disorder), as well as rule out organic, drug, or medical causes of mental health problems were determined with the ADIS-5 (Brown & Barlow, 2014). Higher score indicate worse outcome.	Baseline

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Nur Hani Zainal, M.S., The Pennsylvania State University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Mindfulness; Self-help; Mobile app; Digital health; Ecological momentary intervention
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: STUDY00010664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No