Brief Smartphone Treatment Study for Generalized Anxiety Disorder

This study is looking into whether a short smartphone-based mindfulness program can help people with Generalized Anxiety Disorder (GAD). You would use a smartphone app called PACO. One group will get a mindfulness program that regularly prompts them to practice mindfulness skills, while another group will use a self-monitoring version of the app. Researchers want to see if the mindfulness program can reduce anxiety symptoms and repetitive negative thoughts. To join, you need to be an adult with GAD, either a student at Penn State University or an adult who expressed interest through the PSU StudyFinder portal, and interested in seeking treatment. The study is currently unclear about its recruitment status and plans to enroll 300 people.

Study design
This is an interventional study planning to enroll 300 participants. It compares a mindfulness intervention to a placebo, both delivered via a smartphone app.
What's involved
You would use a smartphone app that prompts you to practice skills or self-monitor 5 times a day for 14 days.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check your anxiety symptoms and repetitive thoughts at 14 days after treatment and again at 6 weeks after you are assigned to a group.

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NCT04846777

Brief Smartphone Treatment Study

Recruiting
NAAges 18+InterventionalTreatment
Penn State University
~300 participants
Updated 2022-04-26 on ClinicalTrials.gov
What's tested:Mindfulness ecological momentary interventionSelf-monitoring placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline Generalized Anxiety Disorder Symptoms at 14-Day Post-Treatment
Measured over Baseline to 14-Day Post-Treatment
+3 more outcomes measured
Generalized Anxiety Disorder
1 sites across 1 states
Pennsylvania1
  • Nur Hani Zainal, M.S. · PRINCIPAL_INVESTIGATOR · The Pennsylvania State University

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Eligibility criteria

Inclusion

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
Participant currently undergoing
Presence of suicidality, mania, psychosis, or substance use disorders

Exclusion

Below age 18
  • Change from Baseline Generalized Anxiety Disorder Symptoms at 14-Day Post-TreatmentBaseline 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.

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

  • Change from Baseline Perseverative Cognitions at 14-Day Post-TreatmentBaseline 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.

  • Change from Baseline Perseverative Cognitions at 6-Week Post-RandomizationBaseline 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.