Clinical trial NCT06434883: Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression
Official title: Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression A Clinical Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression Anxiety Disorder
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2024-05-30
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Patient Health Questionnaire-8 (PHQ8)
timeFrame: Change from baseline to immediately post-intervention and 3-week follow-up
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Change from baseline to immediately post-intervention and 3-week follow-up
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline to immediately post-intervention and 3-week follow-up
measure: Perceived Stress Scale (PSS-10)
timeFrame: Change from baseline to immediately post-intervention and 3-week follow-up
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Change from baseline to immediately post-intervention and 3-week follow-up
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: Change from baseline to immediately post-intervention and 3-week follow-up
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
affiliation: University of Southern Denmark
name: Ulrich Kirk, PhD
role: PRINCIPAL_INVESTIGATOR
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