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Behavioral Intervention

App-Based Program for Anxiety and Depression

N/A
Waitlist Available
Led By Ulrich Kirk, PhD
Research Sponsored by University of Southern Denmark
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptoms of anxiety (defined as a score of 10 or greater on the GAD-7) and/or depression (defined as a score of 10 or greater on the PHQ-8)
18+ years old
Must not have
A diagnosis of any of the following conditions: self-reported schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder, recent trauma to the head or brain damage, severe cognitive impairment, serious physical health concerns necessitating surgery or with a prognosis of less than 6 months, or pregnancy
Not being on a stable dose of anxiety or depression medication for ≥4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately post-intervention and 3-week follow-up
Awards & highlights

Summary

This trial aims to test a phone app designed to help people with anxiety and depression. These mental health conditions are common and can negatively impact a person's quality of life. The app uses cognitive-beh

Who is the study for?
This trial is for adults with elevated anxiety or depression. Participants should have symptoms of these conditions but not be currently receiving treatment. It's not specified who can't join, so generally those with other mental health treatments or conflicting conditions may be excluded.
What is being tested?
The study tests a guided app-based program by Headspace that combines cognitive behavioral therapy (CBT) and mindfulness to treat anxiety and depression. Participants will either use the app or be on a waitlist for comparison over a period of 3 weeks, followed by another 3-week assessment.
What are the potential side effects?
Since this intervention involves an app-based mental health program, typical side effects associated with medications are not expected. However, users might experience discomfort if confronting challenging emotions during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have symptoms of anxiety or depression with scores indicating moderate severity.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe mental health issues, serious physical health concerns requiring surgery soon, a prognosis of less than 6 months, or am not pregnant.
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I have not been on a stable dose of medication for anxiety or depression for at least 4 weeks.
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I have been hospitalized for psychiatric reasons at least twice in the last 6 months.
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I finished a therapy program with exercises for my thoughts and behaviors in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to immediately post-intervention and 3-week follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to immediately post-intervention and 3-week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
General Anxiety Disorder-7 (GAD-7)
Patient Health Questionnaire-8 (PHQ8)
Secondary outcome measures
Mindful Attention Awareness Scale (MAAS)
Perceived Stress Scale (PSS-10)
The Pittsburgh Sleep Quality Index (PSQI)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WaitlistExperimental Treatment1 Intervention
Group II: Anxiety/Depression ProgramActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityOTHER
146 Previous Clinical Trials
28,285 Total Patients Enrolled
University of Southern DenmarkLead Sponsor
540 Previous Clinical Trials
1,949,688 Total Patients Enrolled
Ulrich Kirk, PhDPrincipal InvestigatorUniversity of Southern Denmark
2 Previous Clinical Trials
357 Total Patients Enrolled
~112 spots leftby Mar 2025
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