Loading clinical trials...
Loading clinical trials...
Adherence and Efficacy of an Unguided Internet-Based Relaxation Program for Stress and Anxiety: Insights From Two Randomized Controlled Trials
This study aimed to evaluate the effectiveness and adherence of a fully automated, unguided internet-based relaxation program designed to reduce stress and anxiety in Hungarian adults with English proficiency. Conducted through two randomized controlled trials, the program delivered evidence-based audio exercises (e.g., mindfulness, breathing, progressive muscle relaxation, and imagery techniques) via the web. The key research questions were whether this non-native English language program could reduce symptoms of anxiety, stress, and depression, and whether adherence could be improved through design modifications. The first trial tested the original 4-week version, while the second trial tested a 3-week modified version with adherence-enhancing features. Primary outcomes included changes in anxiety, depression, and stress. The study contributes to understanding the feasibility and potential of low-cost, language-accessible digital interventions for underserved populations in less structured, real-world settings.
Study 1 tested a four-week program called the "28-day Relaxation Challenge." It included seven short audio sessions per week (3-12 minutes), incorporating mindfulness, mantra meditation, progressive muscle relaxation, guided imagery, acceptance-based techniques, and imaginal exposure. Participants were instructed to complete one audio session daily. Weekly assessments were administered to track engagement and symptom change. The content was housed on a Google Drive folder, and access to new exercises was contingent on completing weekly questionnaires. Based on findings from the first trial, Study 2 implemented several design enhancements aimed at improving adherence. The revised program reduced the duration from four to three weeks and repackaged the content into fewer but longer weekly modules (3-4 per week, 9-23 minutes each), integrating several techniques into each module. Delivery was upgraded to a streamlined website interface, incorporating videos with on-screen text, simplified navigation, and built-in reminders. Motivational and reinforcement emails, as well as reflective end-of-week questions, were introduced to foster intrinsic motivation and usability. The intervention remained fully automated and unguided. Both trials used waitlist control groups and were conducted with a 1:1 allocation ratio. Participants were recruited through Hungarian psychoeducational social media platforms without geographic or financial restrictions. Outcome measures included the Depression Anxiety Stress Scales (DASS-21), State-Trait Anxiety Inventory (STAI), and Perceived Stress Scale (PSS), among others. Adherence was monitored via self-reported engagement and weekly check-ins. Statistical analyses included both per-protocol and modified intention-to-treat (MITT) frameworks. The MITT sample included those who completed the first weekly assessment, serving as a proxy for program initiation. This research contributes to the understanding of how design adjustments in unguided digital mental health programs influence engagement and outcomes in real-world populations, particularly among non-native English speakers accessing interventions in English. The study also offers practical insight into feasible low-cost solutions for stress and anxiety in underserved populations.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Eötvös Loránd University PPK Psychology Department
Budapest, Hungary
Start Date
June 3, 2023
Primary Completion Date
April 3, 2024
Completion Date
April 30, 2024
Last Updated
August 1, 2025
1,186
ACTUAL participants
Relaxation Self-Coach
BEHAVIORAL
Lead Sponsor
Eotvos Lorand University
NCT07478393
NCT07456631
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions