Unguided Internet-based Relaxation Program for Anxiety

Eotvos Lorand University

Status: Completed

Conditions: Stress (Psychology); Anxiety

Treatments: Behavioral: Relaxation Self-Coach

Study type: Interventional

Funder types: Other

Identifiers

NCT07098013

PD 143491 (Other Grant/Funding Number)

2023/603

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,186 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,186 participants in 2 patient groups

Internet-based Anxiety Intervention

Experimental group

Description:

Participants received access to a fully automated, unguided internet-based relaxation program designed to reduce stress and anxiety. The program included evidence-based audio exercises such as mindfulness, deep breathing, progressive muscle relaxation, imagery, and acceptance-based practices. In Trial 1, participants completed a 4-week version with 28 short daily exercises. In Trial 2, a modified 3-week version with longer, fewer sessions. All materials were delivered in English to Hungarian non-native speakers via a website, without therapist support.

Treatment:

Behavioral: Relaxation Self-Coach

Waitlist Control

No Intervention group

Description:

Participants in the control arm were placed on a waitlist and did not receive access to the relaxation program during the active intervention phase. They were informed that they would gain full access to the same program after completing post-intervention assessments. During the waiting period, they completed the same online self-assessments (e.g., stress, anxiety, depression scales) as the intervention group. Automated reminder emails encouraged assessment completion and informed participants of their upcoming access to the program. No therapeutic content was delivered during the waitlist period.