Clinical trial NCT06744452: App-based Stress Management with the MHealth Application "harmony"
Official title: App-based Stress Management: a Pragmatic Randomized Controlled Trial on the Efficacy of the MHealth Application "harmony"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Self Efficacy
Resilience, Psychological
Goal Achievement
Well-Being, Psychological
Keywords: Stress management
Stress prevention
Application
App-based prevention
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Increased stress level (PSS-10 \&gt;= 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.

Primary outcomes:
measure: Change from baseline stress at 6 weeks and 12 months
timeFrame: Baseline, 6-week follow-up, 12-week follow-up
measure: Change from baseline stress symptoms at 6 weeks and 12 months
timeFrame: Baseline, 6-week follow-up, 12-week follow-up
Secondary outcomes:
measure: Subjective well-being
timeFrame: Baseline, 6-week follow-up, 12-week follow-up
measure: Resilient coping
timeFrame: Baseline, 6-week follow-up, 12-week follow-up
measure: Self-efficacy
timeFrame: Baseline, 6-week follow-up, 12-week follow-up
measure: Life satisfaction
timeFrame: Baseline, 6-week follow-up, 12-week follow-up
measure: Goal Attainment
timeFrame: Baseline, 6-week follow-up, 12-week follow-up
measure: Experience in Social Systems (EXIS; Hunger et al., 2017)
timeFrame: Baseline, 6-week follow-up, 12-week follow-up
Other outcomes:
measure: Frequency of application use
timeFrame: 6-week follow-up, 12-week follow-up (experiment group only)
measure: Duration of application use
timeFrame: 6-week follow-up, 12-week follow-up (experiment group only)
measure: Extent of application use
timeFrame: 6-week follow-up, 12-week follow-up (experiment group only)
measure: User experience
timeFrame: 6-week follow-up, 12-week follow-up (experiment group only)
measure: User satisfaction
timeFrame: 6-week follow-up, 12-week follow-up (experiment group only)
Locations:
city: Witten
country: Germany
facility: Witten/Herdecke University
state: North Rhine-Westphalia
Study officials:
affiliation: University of Witten/Herdecke
name: Christina Hunger-Schoppe, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Apolinario-Hagen J, Hennemann S, Fritsche L, Druge M, Breil B. Determinant Factors of Public Acceptance of Stress Management Apps: Survey Study. JMIR Ment Health. 2019 Nov 7;6(11):e15373. doi: 10.2196/15373.