Unguided Internet-based Relaxation Program for Anxiety

NCT07098013 | Completed

• 2 other identifiers: 2023/603PD 143491
• Study Type: interventional
• Target: 1,186
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Stress (Psychology)

Outcome Measures

Primary Outcomes (3)

• State and Trait Anxiety Inventory

  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.

  Pre-and postintervention (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2).

• Depression, Anxiety and Stress Scale

  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).

  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).

• Perceived Stress Scale

  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.

  Pre- and post-intervention (after 4 weeks in Trial 1, and after 3 weeks in Trial 2).

Secondary Outcomes (3)

• Burnout (Maslach Burnout Inventory - General Survey)

  Pre- and post-intervention. (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2)

• Self-Efficacy (General Self-Efficacy Scale, GSE)

  Pre- and post-intervention. (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2)

• Resilience (Connor-Davidson Resilience Scale, CD-RISC-10)

  Pre- and post-intervention. (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2)

Study Arms (2)

Internet-based Anxiety Intervention

EXPERIMENTAL

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.

Behavioral: Relaxation Self-Coach

Waitlist Control

NO INTERVENTION

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.

Interventions

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.

Internet-based Anxiety Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Eotvos Lorand University: lead

Study Sites (1)

Eötvös Loránd University PPK Psychology Department

Budapest, Hungary

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 1, 2025
• Study Start: June 3, 2023
• Primary Completion: April 3, 2024
• Study Completion: April 30, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

HU (1)