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Completed

NCT Number: NCT07098013

Unguided Internet-based Relaxation Program for Anxiety

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eötvös Loránd University PPK Psychology Department

Budapest, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being at least 18 years old
  • having a self-reported at least medium level English proficiency
  • Internet literacy (an an implicit eligibility criterion, as the whole procedure was done entirely online)

There was no exclusion criteria.

Treatment and study plan

Relaxation Self-Coach

Behavioral

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.

Primary outcomes

  1. State and Trait Anxiety Inventory

    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.

  2. Depression, Anxiety and Stress Scale

    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).

  3. Perceived Stress Scale

    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.

Secondary outcomes

  1. Burnout (Maslach Burnout Inventory - General Survey)

    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).

  2. Self-Efficacy (General Self-Efficacy Scale, GSE)

    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.

  3. Resilience (Connor-Davidson Resilience Scale, CD-RISC-10)

    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.

Sponsors and collaborators

Lead sponsor

Eotvos Lorand University

Other

Registry information

Official study title

Adherence and Efficacy of an Unguided Internet-Based Relaxation Program for Stress and Anxiety: Insights From Two Randomized Controlled Trials

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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