Healthy ParticipantsNCT05115240
The Effects of a Brief Mindfulness Intervention on Emotional Responses and the Moderating Role of Interoception
A study testing Body Scan and Audio-book in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
Trial summary
This study examines the effects of a brief mindfulness intervention (body scan) on emotional responses (e.g., affect, heart rate variability (HRV)) compared to an active control group. Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Body Scan and Audio-book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fluent in the German language
- ability to give informed consent
Who cannot join
- cardiovascular disease (previous myocardial infarction, hypertension)
- neurological disorders (epilepsy, stroke, multiple sclerosis)
- continuous medication intake (exceptions: contraceptives, nutritional supplements, L-thyroxine for hypothyroidism are allowed)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Marburg, Hesse, 35032
About this study
This study examines the effects of a brief mindfulness intervention (body scan) on emotional responses (e.g., affect, heart rate variability (HRV)) compared to an active control group. Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception on the mindfulness intervention's effects will also be examined.
Read the detailed description
This 3-armed study examines the effects of a brief mindfulness intervention (audio-guided body scan) on emotional responses (e.g., affect, and heart rate variability (HRV)) compared to an active control group (listening to an audio-book). Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception (i.e., interoceptive accuracy as assessed by the Schandry task) on the mindfulness intervention's effects will also be examined.
- Conditions
- Healthy Participants
- Being tested
- Body Scan, Audio-book
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body ScanBehavioural
The body scan intervention aims to raise one's awareness of one's own body. It is considered a relaxation, meditation or mindfulness intervention. During the body scan participants will walk through his or her body by focusing their mind on specific body parts without analyzing, judging or reacting.
Audio-bookOther
Participants listen to an audio book for the same amount of time as the body scan groups
| Study group | Role | What they receive |
|---|---|---|
| Audio-guided mindfulness-based intervention (body scan) | Experimental | Not described Receives: Behavioral: Body Scan |
| Enhanced Audio-guided mindfulness-based intervention (body scan) | Experimental | Participants undergo the same audio-guided body scan intervention. However, in this arm the instruction focuses on the positive effects of mindfulness-based interventions and body scan aiming to optimize participants' interventions outcome expectations of the intervention. The idea of this arm is to assess whether the effects of the mindfulness-based intervention can be augmented by boosting participants positive expectations prior to the intervention. Receives: Behavioral: Body Scan |
| Audio-Book | Active comparator | Participants in this group listen to an audio-book for the same duration as the participants in the two experimental groups. Receives: Other: Audio-book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in affect
Participants are asked to rate adjectives regarding their current mood (positive and negative) at two time points (baseline and after body scan or active control intervention) on a questionnaire. Change scores are calculated (post- minus pre-scores).
Instrument: Positive and Negative Affect Scale (PANAS) by Watson, Clark, and Tellegen (1988) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Range for sum score of positive/negative affect: 10-50. For positive affect higher scores are better; for negative affect lower scores are better.
Measured: Change from pre (baseline) to post scores (30 minutes later)
Secondary outcomes (4)
Change in perceived stress
Participants are asked to rate how stressed they feel at the moment at two time points (baseline and after body scan or active control intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores). More negative change scores are better since it indicates a stronger stress reduction (maximum reduction: -100). Higher positive change scores are worse since this indicates an increase in perceived stress (maximum increase: +100). Range of change scores: -100 - +100).
Measured: Change from pre (baseline) to post scores (30 minutes later)
Change in heart rate variability (HRV)
Heart rate variability (HRV) describes the variations between two successive heart beats and is considered a measure for cardiac adaptation to internal and external stimuli. HRV is considered an important transdiagnostic biomarker of health. HRV is frequently quantified using time- domain measures such as the standard deviation of NN intervals (SDNN) and the root mean square of successive differences between normal heartbeats (RMSSD). For HRV levels higher scores are better
Measured: Change from pre (baseline) to post scores (30 minutes later)
Change in interoceptive accuracy
The heartbeat perception task (Schandry, 1981) encompasses several trials in which participants are instructed to silently count their heartbeats and report the number they counted after each trial. Reported and actual number of heart beats (as assessed by ECG) will be used to calculate a heartbeat detection index (error score).
Measured: Change from pre (baseline) to post scores (30 minutes later)
Change in state anxiety and depression
The State-Trait-Anxiety-Depression-Inventory (STADI) (Laux, L. Hock, M., Bergner-Köther, R., Hodapp, V. \& Renner, K., 2013) measures participants' state anxiety (10 items) and state depression (10 items) severity. Each item can be answered on a 4-point-scale from 1 (not at all) - 4 (very much). Sum scores are calculated and range from 10-40 for each scale (depression and anxiety). Lower scores indicate lower severity (i.e., less negative mood).
Measured: Change from pre (baseline) to post scores (30 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Oct 2021
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115240
- Sponsor's protocol ID
- Mindfulness and interoception
- Status last verified
- Aug 2024
- First submitted
- 29 Oct 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data will be shared with researchers providing a relevant and methodologically sound proposal
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Brief Mindfulness Intervention on Emotional Responses and the Moderating Role of Interoception
- ClinicalTrials.gov ID
- NCT05115240
- Acronym / sponsor ID
- Mindfulness and interoception
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effects of a brief mindfulness intervention (body scan) on emotional responses (e.g., affect, heart rate variability (HRV)) compared to an active control group. Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception on the mindfulness intervention's effects will also be examined.
Detailed description
This 3-armed study examines the effects of a brief mindfulness intervention (audio-guided body scan) on emotional responses (e.g., affect, and heart rate variability (HRV)) compared to an active control group (listening to an audio-book). Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception (i.e., interoceptive accuracy as assessed by the Schandry task) on the mindfulness intervention's effects will also be examined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Audio-guided mindfulness-based intervention (body scan) | Experimental | Behavioral: Body Scan |
| Enhanced Audio-guided mindfulness-based intervention (body scan) | Experimental | Behavioral: Body ScanParticipants undergo the same audio-guided body scan intervention. However, in this arm the instruction focuses on the positive effects of mindfulness-based interventions and body scan aiming to optimize participants' interventions outcome expectations of the intervention. The idea of this arm is to assess whether the effects of the mindfulness-based intervention can be augmented by boosting participants positive expectations prior to the intervention. |
| Audio-Book | Active comparator | Other: Audio-bookParticipants in this group listen to an audio-book for the same duration as the participants in the two experimental groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fluent in the German language
- ability to give informed consent
Key exclusion criteria (4 listed)
- cardiovascular disease (previous myocardial infarction, hypertension)
- neurological disorders (epilepsy, stroke, multiple sclerosis)
- continuous medication intake (exceptions: contraceptives, nutritional supplements, L-thyroxine for hypothyroidism are allowed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body ScanThe body scan intervention aims to raise one's awareness of one's own body. It is considered a relaxation, meditation or mindfulness intervention. During the body scan participants will walk through his or her body by focusing their mind on specific body parts without analyzing, judging or reacting. | Behavioural | Audio-guided mindfulness-based intervention (body scan), Enhanced Audio-guided mindfulness-based intervention (body scan) |
| Audio-bookParticipants listen to an audio book for the same amount of time as the body scan groups | Other | Audio-Book |
Primary outcome
Change in affect
Time frame: Change from pre (baseline) to post scores (30 minutes later)
Participants are asked to rate adjectives regarding their current mood (positive and negative) at two time points (baseline and after body scan or active control intervention) on a questionnaire. Change scores are calculated (post- minus pre-scores). Instrument: Positive and Negative Affect Scale (PANAS) by Watson, Clark, and Tellegen (1988) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Range for sum score of positive/negative affect: 10-50. For positive affect higher scores are better; for negative affect lower scores are better.
4 secondary outcomes
Change in perceived stress
Time frame: Change from pre (baseline) to post scores (30 minutes later)
Change in heart rate variability (HRV)
Time frame: Change from pre (baseline) to post scores (30 minutes later)
Change in interoceptive accuracy
Time frame: Change from pre (baseline) to post scores (30 minutes later)
Change in state anxiety and depression
Time frame: Change from pre (baseline) to post scores (30 minutes later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided. Individual patient data will be shared with researchers providing a relevant and methodologically sound proposal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Scan and Audio-book in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in affect (time frame: Change from pre (baseline) to post scores (30 minutes later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.