Evidence map›Paper›PMID 29973165›Full record

Trial reportBMC public health2018

The TALENT II study: a randomized controlled trial assessing the impact of an individual health management (IHM) on stress reduction.

Dieter Melchart, Erich Wühr, Kristina Wifling, Beatrice E Bachmeier

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC public health, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Dieter MelchartDirector of the Competence Center for Complementary Medicine and Naturopathy (CoCoNat), Klinikum rechts der Isar, Technische Universität München, D-80801, Munich, Germany. Dieter.melchart@tum.de.ORCID 0000-0001-9418-9761
Erich WührMember of the faculty for Applied Health Care Science, Deggendorf Institute of Technology DIT, D-94469, Deggendorf, Germany.
Kristina WiflingCompetence Center for Complementary Medicine and Naturopathy (CoCoNat), Klinikum rechts der Isar, Technische Universität München, D-80801, Munich, Germany.
Beatrice E BachmeierCompetence Center for Complementary Medicine and Naturopathy (CoCoNat), Klinikum rechts der Isar, Technische Universität München, D-80801, Munich, Germany.
TUM Klinikum · DEDeggendorf Institute of Technology · DEUniversity of Zurich · CH

Funding

Bayerisches Staatsministerium für Gesundheit und Pflege(DE) GE9-2499-KuHeMo-16-V7
6 · The paper itself

Abstract

backgroundUnfavorable lifestyle factors influence the risk of stress disorders. For risk reduction, lifestyle modifications, such as regular physical activity, balanced nutrition and competence in stress management, are a means of choice. The clinical study examines the efficacy of an intensive lifestyle intervention, named Individual Health Management (IHM), - with regard to a reduction of perceived stress. The study is supported by the major regional health insurance, which conducts, in cooperation with the Traditional Chinese Medicine (TCM) hospital, Bad Kötzting, a local model project offering insurants the IHM program as prevention measure against stress and related aftermath.

methodsThe study is a controlled, randomized, monocentric trial with a 12-months intervention phase. Feasible persons are checked according to inclusion and exclusion criteria and assigned to the intervention or control group. Randomization ratio is 1:1. (A) Participants of the intervention group receive the lifestyle program IHM, have access to a web-based health portal ( www.viterio.de ), and join 3 full-day and 10 two-hour training sessions during the first 3 months. During the remaining 9 months, 4 training sessions and a weekly monitoring are performed with remote assistance. Besides measurement of perceived stress, examinations include burnout symptoms, heart rate variability, laboratory and physical findings. Further patient reported outcomes are documented (e.g. well-being, life satisfaction, severity of mood state, sense of coherence, psycho-vegetative test, cardio-metabolic risk factors, hypertension and diabetes risk. (B) Participants in the control group have access to the intensive lifestyle intervention IHM after a waiting period of at least 6 months. Examinations are conducted at baseline, after 3 and 6 months and in the intervention group additionally after 9 and 12 months. The confirmatory analysis examines the differences between the two groups with regard to changes in perceived stress after 6 months compared to the initial value. DISCUSSION: In order to enhance adherence, avoid attrition and to insure data quality, different measures will be implemented in the study. Based on a blended learning concept including a web-based e-health tool named VITERIO®, the program promises to achieve sustainable effects in perceived stress.

trial registrationGerman Clinical Trial Register Freiburg (DRKS): DRKS00013040 (date registered 2017-10-1).

Indexed as

Life StyleRisk Reduction BehaviorAdolescentAdultAgedFemaleHealth PromotionHumansMaleMiddle AgedProgram EvaluationStress, PsychologicalYoung AdultBurnoutE-healthIndividual health management (IHM)Intensive lifestyle interventionPreventionStressTraditional Chinese medicine (TCM)Yang sheng

Identifiers

PMID29973165
PMCPMC6030744
OpenAlexW2810503323

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.