CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 168 enrolled
Drug / intervention
Anxiety/Depression Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06434883
NCT06434883N/ACompleted

Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression A Clinical Randomized Controlled Trial

University of Southern Denmark·interventional·Posted May 30, 2024·Updated Jul 1, 2025

In Brief

A clinical study evaluating Anxiety/Depression Program and Waitlist for Depression Anxiety Disorder. Completed, enrolled 168 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20252026
First PostedMay 30, 2024
Enrollment StartOct 4, 2024
Primary CompletionApr 10, 2025
Study CompletionJun 26, 2025
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.1 years ago

Interventions

Anxiety/Depression Programbehavioral

Participants will complete the Headspace Anxiety/Depression Program, which is a 21 day program based on CBT, combined with mindfulness. The program is trans-diagnostic in nature (i.e. addresses both anxiety and depression symptoms).

Waitlistother

Participants will continue their regular routines for an 21 day period and will not be assigned to an intervention.