AnxietyNCT07098013
Unguided Internet-based Relaxation Program for Anxiety
A study testing Relaxation Self-Coach in people with Anxiety and Stress (Psychology), run by Eotvos Lorand University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress (Psychology)
- What is being tested?
- Relaxation Self-Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,186 participants
- Where
- 1 siteHungary
- Study dates
- 3 Jun 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence and Efficacy of an Unguided Internet-Based Relaxation Program for Stress and Anxiety: Insights From Two Randomized Controlled Trials
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.
Read the 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)
- Being tested
- Relaxation Self-Coach
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Self-CoachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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)
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).
Measured: Pre- and post-intervention. (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2)
Self-Efficacy (General Self-Efficacy Scale, GSE)
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.
Measured: 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)
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.
Measured: Pre- and post-intervention. (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start3 Jun 2023
- Primary completion3 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eotvos Lorand University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Csirmaz, Eotvos Lorand University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098013
- Sponsor's protocol ID
- 2023/603
- Other IDs
- PD 143491
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) is available to researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and Efficacy of an Unguided Internet-Based Relaxation Program for Stress and Anxiety: Insights From Two Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT07098013
- Acronym / sponsor ID
- 2023/603
- Conditions
- Anxiety, Stress (Psychology)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,186 participants (actual)
- Lead sponsor
- Eotvos Lorand UniversityUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based Anxiety Intervention | Experimental | Behavioral: Relaxation Self-CoachParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation Self-CoachThis 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. | Behavioural | Internet-based Anxiety Intervention |
Primary outcome
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.
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).
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) is available to researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Self-Coach in people with Anxiety and Stress (Psychology), run by Eotvos Lorand University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State and Trait Anxiety Inventory (time frame: Pre-and postintervention (intervention lasts 4 weeks in Trial 1, and 3 weeks in Trial 2).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.