Trial Summary
What is the purpose of this trial?Generalized anxiety disorder is a mental health disorder characterized by feelings of tension and worry with physical symptoms including increased blood pressure. Approximately 20% of US adults reported an anxiety disorder in the past year and an estimated 31% of US adults reported anxiety at some time in their lives. Anxiety can be experienced throughout one's life and levels of anxiety can increase with stressful life events, physical health conditions, and medication use. Chronic, untreated anxiety has been linked to headaches, dizziness, depression, high blood pressure, heart disease, digestive disorders, and a worsened immune system - greatly impacting one's overall quality of life (QOL).
Anxiety and depression are highly comorbid, with approximately 50-60% of those with anxiety symptoms also experiencing depression symptoms. Experiencing these disorders and symptoms comorbidly may further worsen one's mental health and overall QOL. Untreated, chronic depression can heighten symptoms of depression leading to increased risk of heart disease, sleep disruptions, weight gain/loss, a weakened immune system, physical pains, and suicide attempts.
Anxiety and depression are commonly treated using various psychotherapeutic techniques including cognitive behavioral therapy (CBT) and acceptance and commitment therapy techniques administered by a licensed therapist. However, therapy has many barriers to treatment including insurance not covering treatments, overall treatment cost, unsure where to seek treatment/no access to a therapist, and therapy being unavailable and inconvenient due to scheduling during the workday. As such, app-based mental health tools have increased in popularity to improve access and affordability to effective mental health treatments.
The purpose of the study is to examine the effectiveness of a guided anxiety/depression app-based program by Headspace, which uses CBT with mindfulness to improve anxiety and depression symptoms in a population with elevated baseline anxiety and/or depression. The study will employ a 2-arm app-based intervention involving 1 active intervention and a waitlist control for a duration of 3 weeks, followed by a 3-week follow-up assessment.
Eligibility Criteria
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.Inclusion Criteria
Based in the U.S.
I have been on a stable dose of anxiety or depression medication for at least 4 weeks.
Access to a smartphone device, as the intervention will be delivered via a smartphone application
+2 more
Exclusion Criteria
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.
Risks associated with suicidal ideation and risk of self-harm
I have not been on a stable dose of medication for anxiety or depression for at least 4 weeks.
+2 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: WaitlistExperimental Treatment1 Intervention
Group II: Anxiety/Depression ProgramActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fralin Biomedical Research Institute at VTCRoanoke, VA
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Who Is Running the Clinical Trial?
University of Southern DenmarkLead Sponsor
Virginia Polytechnic Institute and State UniversityCollaborator