Generalized Anxiety DisorderNCT04846777
Brief Smartphone Treatment Study
A study testing Mindfulness ecological momentary intervention in people with Generalized Anxiety Disorder, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Mindfulness ecological momentary intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Below age 18
- Failure to meet any of above inclusion criteria
- Participant currently undergoing
- Presence of suicidality, mania, psychosis, or substance use disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Pennsylvania State University
University Park, Pennsylvania, 16802
Nur Hani Zainal, M.S., 917-767-7088, nvz5057@psu.edu
Michelle G. Newman, Ph.D., 814-883-4572, mgn1@psu.edu
About this study
Official title: 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Mindfulness ecological momentary intervention, Self-monitoring placebo
- Keywords
- Ecological momentary intervention, Mindfulness, Self-help, Digital health, Mobile app
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness ecological momentary interventionDevice
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 placeboDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Self-monitoring placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6-Week Post-Randomization
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6-Week Post-Randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start14 Nov 2018
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle G. Newman, Penn State University
- Investigators
- Nur Hani Zainal, M.S., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846777
- Sponsor's protocol ID
- STUDY00010664
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2021
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zainal NH, Newman MG. Who engages? Machine learning insights into digital mindfulness-based intervention for generalized anxiety disorder. J Affect Disord. 2026 Apr 15;399:120963. doi: 10.1016/j.jad.2025.120963. Epub 2025 Dec 19.
PubMed 41422949Zainal 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.
PubMed 38787613
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Smartphone Treatment Study for Anxiety and Depression
- ClinicalTrials.gov ID
- NCT04846777
- Acronym / sponsor ID
- STUDY00010664
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Ecological momentary intervention, Mindfulness, Self-help, Digital health, Mobile app
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness ecological momentary intervention | Experimental | Device: Mindfulness ecological momentary interventionThe 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. |
| Self-monitoring placebo | Placebo comparator | Device: Self-monitoring placeboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Below age 18
- Failure to meet any of above inclusion criteria
- Participant currently undergoing
- Presence of suicidality, mania, psychosis, or substance use disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness ecological momentary interventionAccess 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. | Device | Mindfulness ecological momentary intervention |
| Self-monitoring placeboAccess 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. | Device | Self-monitoring placebo |
Primary outcome
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.
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.
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.
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.
18 secondary outcomes
Change from Baseline Depression Symptom Severity at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Depression Symptom Severity at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Change from Baseline Attentional Control at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Attentional Control at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Change from Baseline Working Memory at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Working Memory at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Change from Baseline Set-Shifting at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Set-Shifting at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Change from Baseline Inhibitory Control at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Inhibitory Control at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Change from Baseline Verbal Fluency at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Verbal Fluency at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Change from Baseline Empathy at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Empathy at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Change from Baseline Interpersonal Reactivity Traits at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Interpersonal Reactivity Traits at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Change from Baseline Trait Mindfulness at 14-Day Post-Treatment
Time frame: Baseline to 14-Day Post-Treatment
Change from Baseline Trait Mindfulness at 6-Week Post-Randomization
Time frame: Baseline to 6-Week Post-Randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Derived from this study: PubMed 41422949Zainal NH, Newman MG. Who engages? Machine learning insights into digital mindfulness-based intervention for generalized anxiety disorder. J Affect Disord. 2026 Apr 15;399:120963. doi: 10.1016/j.jad.2025.120963. Epub 2025 Dec 19.
- Derived from this study: PubMed 38787613Zainal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nur Hani Zainal, M.S. principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness ecological momentary intervention in people with Generalized Anxiety Disorder, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nur Hani Zainal, M.S. (917-767-7088, nvz5057@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Generalized Anxiety Disorder Symptoms at 14-Day Post-Treatment (time frame: Baseline to 14-Day Post-Treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846777, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.