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NCT Number: NCT04846777

Brief Smartphone Treatment Study

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline to 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.

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

    Time frame: Baseline to 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.

  3. Change from Baseline Perseverative Cognitions at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  4. Change from Baseline Perseverative Cognitions at 6-Week Post-Randomization

    Time frame: Baseline to 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.

Secondary outcomes

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

    Time frame: Baseline to 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.

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

    Time frame: Baseline to 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.

  3. Change from Baseline Attentional Control at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  4. Change from Baseline Attentional Control at 6-Week Post-Randomization

    Time frame: Baseline to 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.

  5. Change from Baseline Working Memory at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  6. Change from Baseline Working Memory at 6-Week Post-Randomization

    Time frame: Baseline to 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.

  7. Change from Baseline Set-Shifting at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  8. Change from Baseline Set-Shifting at 6-Week Post-Randomization

    Time frame: Baseline to 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.

  9. Change from Baseline Inhibitory Control at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  10. Change from Baseline Inhibitory Control at 6-Week Post-Randomization

    Time frame: Baseline to 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.

  11. Change from Baseline Verbal Fluency at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  12. Change from Baseline Verbal Fluency at 6-Week Post-Randomization

    Time frame: Baseline to 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.

  13. Change from Baseline Empathy at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  14. Change from Baseline Empathy at 6-Week Post-Randomization

    Time frame: Baseline to 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.

  15. Change from Baseline Interpersonal Reactivity Traits at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  16. Change from Baseline Interpersonal Reactivity Traits at 6-Week Post-Randomization

    Time frame: Baseline to 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.

  17. Change from Baseline Trait Mindfulness at 14-Day Post-Treatment

    Time frame: Baseline to 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.

  18. Change from Baseline Trait Mindfulness at 6-Week Post-Randomization

    Time frame: Baseline to 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.

Other outcomes

  1. Mental health disorder screening measures

    Time frame: Baseline

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Brief Smartphone Treatment Study for Anxiety and Depression

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2021
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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