TALENT-Study Stress - A randomized controlled trial to investigate the effectiveness of a lifestyle program (IHM-SEPP) on stress symptoms

Not Applicable

Recruiting

• Conditions: Z73; Z72; Problems related to lifestyle; Problems related to life-management difficulty

• Registration Number: DRKS00013040
• Lead Sponsor: Technische Hochschule Deggendorf - Fakultät Angewandte Gesundheitswissenschaften

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Tedium-Measure = 3,20 (= moderate stress/pre-burnout)
- PSQ total score (Perceived Stress Questionnaire) > 41
- Subjective feeling of stress exposure for more than 3 months
- informed consent

Exclusion Criteria

- being unable to consent for themself
- insufficient skills in German language
- no private access to internet
- known hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg) with or without medication
- known hypotension (systolic blood pressure = 70 mmHg or diastolic blood pressure = 50 mmHg)
- body mass index (BMI) < 17,5
- psychiatric/psychotherapeutic treatment requirements defined as severe signs and symptoms according to the ISR (ICD-10-Symptom Rating) questionnaire in at least one of the subcales depressive syndrome, anxiety syndrome, obsessive-compulsive syndrome, somatoform syndrome, eating disorder syndrome or in the ISR total score
- known psychiatric treatment (with or without medication)
- known diabetes mellitus (type 1 or 2)
- known heart disease (like CHD, arrhythmia, valvular heart defect, cardiac insufficiency)
- known gastric or duodenal ulcers
- known diseases of the liver or kidneys
- known diseases of the eyes (e.g. retinal detachment)
- known disease of the thyroid gland or taking of thyroid hormones
- known disease-related impairments preventing a participation in the lifestyle program (e.g. arthrosis)
- known therapeutic conditions that are due to known risiks/side effects not compatible with participation in the lifestyle program
- known pregnancy (or lactation) or planned in the next year
- participation in another currently cinical trial or during the last 6 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in perceived stress (PSQ total score; Perceived Stress Questionnaire) after 6 months

Secondary Outcome Measures

Name	Time	Method
Tedium-Measure, ICD-10-Symptom-Rating (ISR), tcm diagnosis, tcm constitution, heart rate variability (HRV), heart rate, laboratory findings, waist circumference, blood pressure, stresses and strains, 3-level-stresstest, severity of mood state in general (VAS), life satisfaction (FLZ), WHO-5-well-being, self-efficacy, optimism and pessimism (SWOP), motivation and willingness to change, sense of coherence (SOC-13), social support (SSS), psycho-vegetative test, comprehensive medical history, cardiovascular and metabolic risk factors, hypertension risk, diabetes risk (findrisk), nutrition index, moving index, physical power and the body’s defenses. Examinations are conducted at months 0, 3 and 6. In the intervention group additional examinations are carried out in the course of a longitudinal analysis in months 9 and 12.