Unguided Internet-based Relaxation Program for Anxiety

NCT ID: NCT07098013

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-03
• Study Completion Date: 2024-04-30

Brief Summary

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.

Detailed 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.

Conditions

Anxiety; Stress (Psychology)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based Anxiety Intervention

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.

Group Type: EXPERIMENTAL

Relaxation Self-Coach

Intervention Type: 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.

Waitlist Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Relaxation Self-Coach

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.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eotvos Lorand University

OTHER

Sponsor Role: lead

Responsible Party

Luca Csirmaz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eötvös Loránd University PPK Psychology Department

Budapest, , Hungary

Countries

Hungary

Other Identifiers

PD 143491

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023/603

Identifier Type: -

Identifier Source: org_study_id