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Mindfulness ecological momentary intervention for Generalized Anxiety Disorder

N/A
Recruiting
Led By Nur Hani Zainal, M.S.
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently not receiving treatment from a mental health professional
Presence of Generalized Anxiety Disorder based on the Generalized Anxiety Disorder Questionnaire-IV self-report and Mini International Neuropsychiatric Interview
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline to 14-day post-treatment
Awards & highlights

Study Summary

This trial is testing the efficacy of a 14-day smartphone mindfulness intervention for people with generalized anxiety disorder, compared to a self-monitoring placebo group. The primary outcome measures are reductions in worry and negative perseverative cognitions, and increases in attentional control and executive functioning.

Eligible Conditions
  • Generalized Anxiety Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are not currently seeing a therapist or counselor.
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You have shown interest in receiving treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 14-day post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 14-day post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety Disorders
Anxiety Disorders
Change from Baseline Perseverative Cognitions at 14-Day Post-Treatment
+1 more
Secondary outcome measures
Change from Baseline Attentional Control at 14-Day Post-Treatment
Change from Baseline Attentional Control at 6-Week Post-Randomization
Mental Depression
+15 more
Other outcome measures
Psychiatric Rehabilitation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mindfulness ecological momentary interventionExperimental Treatment1 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.
Group II: Self-monitoring placeboPlacebo Group1 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.

Find a Location

Who is running the clinical trial?

Penn State UniversityLead Sponsor
348 Previous Clinical Trials
124,858 Total Patients Enrolled
3 Trials studying Generalized Anxiety Disorder
174 Patients Enrolled for Generalized Anxiety Disorder
Nur Hani Zainal, M.S.Principal InvestigatorThe Pennsylvania State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being observed in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is presently recruiting participants and was first published on November 14th 2018. The protocol has been refreshed as of April 19th 2022, with the goal being to enrol 300 people at a single site."

Answered by AI

Are there any open enrollment opportunities for this medical experiment?

"The source of truth, clinicaltrials.gov, states that this trial is still looking for participants since its inception in November 2018 and last amendment on April 19th 2022."

Answered by AI

What practical effects is this trial looking to produce?

"The primary goal of this trial, measured over a Baseline to Post-Treatment period, is to observe the Change from Baseline Generalized Anxiety Disorder Symptoms at 6-Week Post-Randomization. Secondary outcomes that will be evaluated include cognitive changes such as Working Memory (WAIS-IV; Wechsler, 2008) and Verbal Fluency (Delis et al., 2001), with larger increases in score denoting better performance. Additionally, changes in Depressiond Anxiety Disorder Symptoms at 6-Week Post-Randomization. Secondary outcomes that will be evaluated include cognitive changes such as Working Memory (WAIS-IV; Wechsler, 2008) and Verbal Fluency (Delis et al., 2001), with larger increases in score denoting better performance. Additionally, changes in Depression Symptom Severity based on Beck's depression inventory (Beck et al., 1996) will also be monitored; wherein lower scores indicate more favourable results."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
California
North Carolina
Other
How old are they?
18 - 65
What site did they apply to?
The Pennsylvania State University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Brief Smartphone Treatment Study
Michelle G. Newman 2018. "Brief Smartphone Treatment Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04846777.
~50 spots leftby Nov 2024
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