Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434883
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-23
Brief Title:
Assessment of an App-based AnxietyDepression Program in a Population With Elevated AnxietyDepression
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Assessment of an App-based AnxietyDepression Program in a Population With Elevated AnxietyDepression A Clinical Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ones 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 ones 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 ones mental health and overall QOL Untreated chronic depression can heighten symptoms of depression leading to increased risk of heart disease sleep disruptions weight gainloss 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 treatmentno 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 anxietydepression app-based program by Headspace which uses CBT with mindfulness to improve anxiety and depression symptoms in a population with elevated baseline anxiety andor 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
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 ones mental health and overall QOL Untreated chronic depression can heighten symptoms of depression leading to increased risk of heart disease sleep disruptions weight gainloss 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 treatmentno 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 anxietydepression app-based program by Headspace which uses CBT with mindfulness to improve anxiety and depression symptoms in a population with elevated baseline anxiety andor 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 studys 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 AnxietyDepression Program or waitlist control Participants will participate in the interventionwaitlist 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None