Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression

NCT ID: NCT06434883

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-04
• Study Completion Date: 2025-06-26

Brief 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.

Detailed Description

Participants who meet the inclusion criteria will complete the informed consent procedure and the baseline assessment consisting of the study's primary outcomes of anxiety (GAD-7) and depression (PHQ-8) and the secondary outcome measures including sleep quality using the PSQI, perceived stress using the PSS-10, mindfulness using the MAAS, well-being using the WEMWBS, and report use of prescription medication. After the baseline assessment, participants will be randomized into one of two groups (Headspace Anxiety/Depression Program or waitlist control). Participants will participate in the intervention/waitlist control group for 3 weeks. Having completed the 3 week intervention, participants will complete the post-intervention assessment consisting of the primary and secondary outcome measures. Finally, participants will complete the follow-up assessment 3 weeks after post-intervention with a questionnaire to assess changes in routines (including physical activity, prescription medication use or treatments), and the primary and secondary outcome measures.

Conditions

Depression Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Anxiety/Depression Program

Group Type: ACTIVE_COMPARATOR

Anxiety/Depression Program

Intervention Type: BEHAVIORAL

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).

Waitlist

Group Type: OTHER

Waitlist

Intervention Type: OTHER

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

Interventions

Anxiety/Depression Program

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).

Intervention Type: BEHAVIORAL

Waitlist

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).
• Prescription medication for anxiety, depressive symptoms provided a stable dose for ≥4 weeks before baseline or no medication.
• 18+ years old.
• Based in the U.S.
• Access to a smartphone device, as the intervention will be delivered via a smartphone application.

Exclusion Criteria

• 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.
• Risks associated with suicidal ideation and risk of self-harm.
• Two or more hospitalizations within the past 6 months for psychiatric reasons.
• Completed CBT (or another "active" form of psychotherapy that includes self-monitoring and cognitive and/or behavioral exercises) delivered by a licensed therapist in the past 6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Ulrich Kirk

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrich Kirk, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, United States

Countries

United States

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Other Identifiers

434587

Identifier Type: -

Identifier Source: org_study_id