Eötvös Loránd University PPK Psychology Department
Budapest, Hungary
NCT Number: NCT07098013
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Budapest, Hungary
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
There was no exclusion criteria.
This intervention is a fully automated, unguided internet-based relaxation program in English. Unlike many digital mental health programs, it required no therapist involvement or incentives and was structured for real-world use. It combined evidence-based techniques-mindfulness, deep breathing, progressive muscle relaxation, guided imagery, and acceptance practices-delivered via audio modules. The program was tested in two formats: a 4-week daily format (28 sessions) and a revised 3-week modular format (21 sessions) with enhanced usability and adherence features, such as a simplified multimedia interface, reminder emails, and optional reflection prompts.
Time frame: Pre-and postintervention (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2).
The State-Trait Anxiety Inventory consists of two 20-item subscales measuring state anxiety (temporary) and trait anxiety (general disposition). Each item is scored from 1 to 4, yielding subscale scores ranging from 20 to 80. Higher scores reflect worse anxiety levels.
Time frame: Pre- and postintervention (intervention lasts 4 weeks in Trial 1 and 3 weeks in Trial 2) + at the end of each week during treatment (at the end of week 1, week 2 and week 3 in Trial 1).
The DASS-21 is a self-report instrument comprising three 7-item subscales measuring depression, anxiety, and stress. Each item is rated on a 4-point scale (0-3), resulting in subscale scores ranging from 0 to 21. Higher scores indicate worse symptoms (i.e., more severe depression, anxiety, or stress).
Time frame: Pre- and post-intervention (after 4 weeks in Trial 1, and after 3 weeks in Trial 2).
The Perceived Stress Scale is a 10-item measure assessing perceived stress over the past month. Items are scored from 0 (never) to 4 (very often), with total scores ranging from 0 to 40. Higher scores represent worse outcomes, indicating greater perceived stress.
Time frame: Pre- and post-intervention. (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2)
The Maslach Burnout Inventory measures burnout across three subscales: Emotional Exhaustion, Cynicism (Depersonalization), and Personal Accomplishment. Each item is rated on a 7-point scale (0-6), with higher scores on Emotional Exhaustion and Cynicism indicating worse burnout, and higher scores on Personal Accomplishment indicating a better outcome (i.e., less burnout).
Time frame: Pre- and post-intervention. (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2)
The General Self-Efficacy Scale contains 10 items scored from 1 (not at all true) to 4 (exactly true), yielding a total score range of 10 to 40. Higher scores reflect better outcomes, indicating greater perceived self-efficacy.
Time frame: Pre- and post-intervention. (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2)
The CD-RISC-10 assesses resilience using 10 items scored from 0 (not true at all) to 4 (true nearly all the time), with total scores ranging from 0 to 40. Higher scores indicate better resilience and psychological adaptability.
Eotvos Lorand University
Other
Adherence and Efficacy of an Unguided Internet-Based Relaxation Program for Stress and Anxiety: Insights From Two Randomized Controlled Trials
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