Plain English Summary
Background and study aims
It is well known that chronic (long-term) stress is a risk factor or intensifier for a variety of physical disorders or illnesses. Chronic stress has been demonstrated to increase cardiovascular (heart disease) risks, musculoskeletal disorders, and mental disorders such as depression. In Traditional Chinese Medicine acupuncture has been used to treat stress-related disorders. First studies have shown that acupuncture may serve as an adequate treatment for people with increased stress. However, well-designed studies demonstrating the effectiveness of acupuncture in chronic stress are still lacking. This study aims to assess the feasibility and acceptability of acupuncture in people with an increased stress level.
Who can participate?
Healthy adults aged 18 and over with an increased stress level
What does the study involve?
At the beginning of the study a diagnostic assessment is carried out for all participants. Afterwards participants are randomly allocated to one of three groups. One group receives verum (true) acupuncture treatment, one group sham acupuncture, and one group is put on a waiting list. Stress is measured at the start of the study, at the end of treatment and at three months after the end of treatment.
What are the possible benefits and risks of participating?
All participants are assessed closely by a professional team at the start of the study. Participants of all groups may benefit from the acupuncture treatment. Participation in this study involves no risks of physical injury or harm.
Where is the study run from?
University Hospital Heidelberg (Germany)
When is the study starting and how long is it expected to run for?
August 2017 to August 2018
Who is funding the study?
1. University Hospital Heidelberg (Germany)
2. Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg (Germany)
Who is the main contact?
Prof. Beate Wild
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pilot randomized-controlled trial on the efficacy of acupuncture in people with an increased stress level
Acronym
AkuRest
Study hypothesis
This pilot study aims to assess the feasibility and acceptability of the study design and treatment.
Study hypotheses:
1. The study design is well accepted by those persons meeting the inclusion criteria. The rate of persons consenting to participation is over 50%, and more than 70% of the included persons complete the study.
2. Explorative: The acupuncture intervention leads to a reduction of the stress level measured by using the Perceived Stress Questionnaire (PSQ-20) and the Patient Health Questionnaire (PHQ stress module).
3. Explorative: Acupuncture leads to alterations in psychoneuroimmunologic and psychophysiologic parameters.
Ethics approval
Ethics Committee of the University of Heidelberg, 12/05/2017, ref: S-011/2017
Study design
Randomized controlled three-armed pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Adults with high self-reported stress levels
Intervention
At the beginning of the study a diagnostic assessment is done for all participants. Afterwards participants are randomized to one out of three groups. The randomization will conducted by using the randomization software “RANDI 2”. Randomization will be stratified by center. The randomization program will be applied by an independent assistant at the University Hospital Heidelberg.
1. Verum acupuncture group. The indicated points of the verum acupuncture are predefined according to literature research and the expertise of the acupuncturist and will be maintained throughout the 10 sessions. Eliciting a De Qi sensation is the aim of the treatment. The individual points may be chosen and altered during the course of treatment by the acupuncturist according to the leading clinical symptoms.
2. Sham acupuncture group. 4-6 standardized points of acupuncture are chosen that are not on acupuncture meridians. These will only be placed superficially without eliciting a so-called De Qi sensation. The control acupuncture points may analogous to the verum acupuncture be changed individually during the course of treatment.
3. Waiting list control group: a group that will, to begin with, not be treated for 3 months.
The intervention consists of 10 sessions (each between 20-30 minutes). Acupuncture will be carried out by a licensed acupuncturist. Intervals between treatments are dependent on the participant and according to plan and feasibility between 3 and 7 days. The total duration of treatment will be up to three months. There will be a follow-up measurement at about three months after the end of treatment.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Feasibility and acceptability: defined as the study design is well accepted by those persons meeting the inclusion criteria, the rate of persons consenting to participation is over 50% and more than 70% of these complete the study. Measured at the end of treatment.
Secondary outcome measures
1. Stress level, measured by the PSQ-20, the PSS, and the PHQ stress module
2. Heart rate variability, measured at all three centers with the same device using a standardized protocol
3. Psychoneuroimmunologic parameters, analysed using blood samples
Measured at baseline (at the beginning of the study), end of treatment, and at three months follow-up
Overall trial start date
28/08/2017
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. PSQ-20 score ≥ 60
2. Age ≥ 18
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
75
Participant exclusion criteria
1. Suicidal ideation
2. Psychiatric disorder
3. Needle phobia
4. Insufficient knowledge of the German language
Recruitment start date
31/08/2017
Recruitment end date
15/06/2018
Locations
Countries of recruitment
Germany
Trial participating centre
Department of General Internal Medicine and Psychosomatics, University Hospital
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
Trial participating centre
Institute of General Practice and Interprofessional Care, University Hospital Tübingen
Tübingen
72076
Germany
Trial participating centre
Centre for Complimentary Medicine, University Hospital Freiburg
Freiburg
79106
Germany
Trial participating centre
The Institute of Immunology, University Hospital Heidelberg
Heidelberg
69120
Germany
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Heidelberg (preparation, design planning, data management, organization, treatment)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg (cooperation centers)
Alternative name(s)
Ministry of Science, Research and Art Baden-Württemberg, MWK
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Germany
Results and Publications
Publication and dissemination plan
The German study protocol is available upon request. The trialists intend to publish the study results in a high-impact journal at about 6 months after the end of the study.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list