App-based Stress Management with the MHealth Application "harmony"

University of Witten/Herdecke

Status: Not yet enrolling

Conditions: Self Efficacy; Resilience, Psychological; Goal Achievement; Well-Being, Psychological; Stress

Treatments: Behavioral: harmony

Study type: Interventional

Funder types: Other

Identifiers

NCT06744452

HARMONY RCT

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy of app-based stress prevention via the harmony application in a prospective, interventive, monocentric, explanatory pilot randomized controlled trial (RCT), with participants' subjective stress experience as the primary endpoint.

Research question: Does usage of the app harmony have a positive impact on the subjective experience of stress of its users? Do usage frequency, intensity or width of content engagement influence the efficacy of the intervention?

Hypothesis: We expect improvement of participants' subjective stress experience, stress-related symptoms, subjective well-being, resilient coping, self-efficacy, life satisfaction and goal-attainment.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Increased stress level (PSS-10 >= 19; corresponds to one standard deviation (SD 6.42)) above the mean (PSS-10 = 12.57) in a representative sample of the German population (Klein et al., 2016)
• Fulfillment of technical minimum requirements (internet and smartphone access with suitable operating systems)
• German language skills at a native level or the ability to use the language at at least B level
• Written informed consent to participate in the study after being informed about the study

Exclusion criteria

• Inclusion criteria not met.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

App-usage across a 12 week time period

Experimental group

Description:

Use of the harmony application, with 6- and 12-week follow-up. Measurements will be taken at baseline as well as at 6- and 12-week follow-up.

Treatment:

Behavioral: harmony

Waitlist-control group

No Intervention group

Description:

Use of the harmony application after a 12-week waiting period. Measurements will be taken at baseline as well as at 6- and 12-week follow-up.