Psychological StressNCT05832632
The Effect of Mindfulness on Psychophysiological Stress in a Population With Elevated Stress Symptoms
A study testing Headspace Basics Program, Headspace Breathing Exercises and Headspace Stress Program in people with Psychological Stress and Physiological Stress, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Stress-related disorders have over the last decade increased and contributed to a worldwide disease burden. At the same time there is limited treatment access for mental health disorders, which has left many people without necessary care. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychological Stress, Physiological Stress
- What is being tested?
- Headspace Basics Program, Headspace Breathing Exercises and Headspace Stress Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Nov 2021to 1 Mar 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate to high perceived stress based on PSS total scores (14-40)
- Fluent in English
Who cannot join
- Regular mindfulness practice for more than 1 month within the last year
- Medical diagnosis e.g. psychiatric/neurological conditions
- Low levels of stress (i.e., less than a score of 14 assessed with the PSS)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark. Department of Psychology.
Odense, 5230
About this study
Official title: A Randomized Controlled Trial Comparing 3 Formats of Mindfulness Interventions to an Active Control Intervention in a Population With Elevated Levels of Stress: Effects of Subjective and Physiological Stress
Stress-related disorders have over the last decade increased and contributed to a worldwide disease burden. At the same time there is limited treatment access for mental health disorders, which has left many people without necessary care. However, in recent years there has been a rise in digital mindfulness interventions. Specifically, these interventions have focused on smartphone-based applications as an effective format for mindfulness training programs. Thus, the goal of this randomized controlled trial is to test the effects of three types of mindfulness programs in a population with elevated stress. The three formats of mindfulness interventions are identical in total training duration but varies in content and intervention length. Specifically, the first intervention consists of programmatic mindfulness content that progress over the course of 30 sessions with a duration of 10 min per session. The second intervention consists of single succinct breathing exercises with no programmatic content over the course of 30 sessions with a duration of 10 min per session. The third intervention consists of mindfulness-based content specifically targeted to people with elevated stress that progress over the course of 20 sessions with a duration of 15 min per session. An active control group listening to an audiobook over the course of 30 sessions with a duration of 10 min per session will be employed and a passive control group.
The study will evaluate outcomes related to subjective stress, sleep quality, mindfulness and physiological effects of stress using HRV.
- Conditions
- Psychological Stress, Physiological Stress
- Being tested
- Headspace Basics Program, Headspace Breathing Exercises, Headspace Stress Program, Active Control (Audiobook)
- Keywords
- Stress, Mindfulness, HRV
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headspace Basics ProgramBehavioural
30-day smartphone-based mindfulness intervention consisting of 10 minutes per day. The program consist of generic mindfulness techniques such as breath awareness, body scans, mindful noting of thoughts and emotions.
Headspace Breathing ExercisesBehavioural
30-day smartphone-based breathing exercises. Each exercise consists of box breathing for 1 minute and participants are instructed to complete 10 sessions corresponding to 10 minutes per day.
Headspace Stress ProgramBehavioural
20-day smartphone-based mindfulness intervention consisting of 15 minutes per day. The Stress program content is based on well-established concepts and practices within stress management, and mindfulness, and is targeted to people with elevated stress.
Active Control (Audiobook)Behavioural
30-day smartphone-based Audiobook book consisting of 10 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Headspace Basics Program | Experimental | Not described Receives: Behavioral: Headspace Basics Program |
| Headspace Breathing Exercises | Experimental | Not described Receives: Behavioral: Headspace Breathing Exercises |
| Headspace Stress Program | Experimental | Not described Receives: Behavioral: Headspace Stress Program |
| Active Control (Audiobook) | Active comparator | Not described Receives: Behavioral: Active Control (Audiobook) |
| Passive Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS-10)
Measured: immediately post intervention
Heart rate variability (HRV)
HRV data will be recorded continuously during a rest period, acute stress period*, and recovery period at both pre and post on a subject-by-subject basis.
*The study will use an acute stress manipulation, specifically the CPT (Cold Pressor Task). The CPT is a standardized physiological acute stressor which has been shown to induce stress, reflected in autonomic stress reactivity (e.g. Lupien et al., 2007; Raio et al., 2017).
Measured: immediately post intervention
Secondary outcomes (2)
The Pittsburgh Sleep Quality Index (PSQI)
Measured: immediately post intervention
Mindful Attention Awareness Scale (MAAS)
Measured: immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start8 Nov 2021
- Primary completion4 Oct 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Headspace Health
- Responsible party
- Sponsor
- Investigators
- Ulrich Kirk, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832632
- Sponsor's protocol ID
- 45345
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen, S., & Janicki-Deverts, D. (2012), Who's Stressed? Distributions of Psychological Stress in the United States in Probability Samples from 1983, 2006, and 2009. Journal of Applied Social Psychology, 42: 1320-1334. https://doi.org/10.1111/j.1559-1816.2012.00900.x
Tian F, Shen Q, Hu Y, Ye W, Valdimarsdottir UA, Song H, Fang F. Association of stress-related disorders with subsequent risk of all-cause and cause-specific mortality: A population-based and sibling-controlled cohort study. Lancet Reg Health Eur. 2022 May 28;18:100402. doi: 10.1016/j.lanepe.2022.100402. eCollection 2022 Jul.
PubMed 35663363World Health Organization. The impact of COVID-19 on mental, neurological and substance use services: results of rapid assessment. Geneva: World Health Organization; 2020. Available from: https://www.who.int/publications-detail-redirect/978924012455
Sorkin DH, Janio EA, Eikey EV, Schneider M, Davis K, Schueller SM, Stadnick NA, Zheng K, Neary M, Safani D, Mukamel DB. Rise in Use of Digital Mental Health Tools and Technologies in the United States During the COVID-19 Pandemic: Survey Study. J Med Internet Res. 2021 Apr 16;23(4):e26994. doi: 10.2196/26994.
PubMed 33822737Philippe TJ, Sikder N, Jackson A, Koblanski ME, Liow E, Pilarinos A, Vasarhelyi K. Digital Health Interventions for Delivery of Mental Health Care: Systematic and Comprehensive Meta-Review. JMIR Ment Health. 2022 May 12;9(5):e35159. doi: 10.2196/35159.
PubMed 35551058Raio CM, Hartley CA, Orederu TA, Li J, Phelps EA. Stress attenuates the flexible updating of aversive value. Proc Natl Acad Sci U S A. 2017 Oct 17;114(42):11241-11246. doi: 10.1073/pnas.1702565114. Epub 2017 Oct 2.
PubMed 28973957Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. doi: 10.1016/j.bandc.2007.02.007. Epub 2007 Apr 26.
PubMed 17466428Kirk U, Staiano W, Hu E, Ngnoumen C, Kunkle S, Shih E, Clausel A, Purvis C, Lee L. App-Based Mindfulness for Attenuation of Subjective and Physiological Stress Reactivity in a Population With Elevated Stress: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Oct 13;11:e47371. doi: 10.2196/47371.
PubMed 37831493
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing 3 Formats of Mindfulness Interventions to an Active Control Intervention in a Population With Elevated Levels of Stress: Effects of Subjective and Physiological Stress
- ClinicalTrials.gov ID
- NCT05832632
- Acronym / sponsor ID
- 45345
- Conditions
- Psychological Stress, Physiological Stress
- Keywords
- Stress, Mindfulness, HRV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Headspace Health
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 27 Apr 2023 (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.
Stress-related disorders have over the last decade increased and contributed to a worldwide disease burden. At the same time there is limited treatment access for mental health disorders, which has left many people without necessary care. However, in recent years there has been a rise in digital mindfulness interventions. Specifically, these interventions have focused on smartphone-based applications as an effective format for mindfulness training programs. Thus, the goal of this randomized controlled trial is to test the effects of three types of mindfulness programs in a population with elevated stress. The three formats of mindfulness interventions are identical in total training duration but varies in content and intervention length. Specifically, the first intervention consists of programmatic mindfulness content that progress over the course of 30 sessions with a duration of 10 min per session. The second intervention consists of single succinct breathing exercises with no programmatic content over the course of 30 sessions with a duration of 10 min per session. The third intervention consists of mindfulness-based content specifically targeted to people with elevated stress that progress over the course of 20 sessions with a duration of 15 min per session. An active control group listening to an audiobook over the course of 30 sessions with a duration of 10 min per session will be employed and a passive control group.
The study will evaluate outcomes related to subjective stress, sleep quality, mindfulness and physiological effects of stress using HRV.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Headspace Basics Program | Experimental | Behavioral: Headspace Basics Program |
| Headspace Breathing Exercises | Experimental | Behavioral: Headspace Breathing Exercises |
| Headspace Stress Program | Experimental | Behavioral: Headspace Stress Program |
| Active Control (Audiobook) | Active comparator | Behavioral: Active Control (Audiobook) |
| Passive Control | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Moderate to high perceived stress based on PSS total scores (14-40)
- Fluent in English
Key exclusion criteria (3 listed)
- Regular mindfulness practice for more than 1 month within the last year
- Medical diagnosis e.g. psychiatric/neurological conditions
- Low levels of stress (i.e., less than a score of 14 assessed with the PSS)
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 |
|---|---|---|
| Headspace Basics Program30-day smartphone-based mindfulness intervention consisting of 10 minutes per day. The program consist of generic mindfulness techniques such as breath awareness, body scans, mindful noting of thoughts and emotions. | Behavioural | Headspace Basics Program |
| Headspace Breathing Exercises30-day smartphone-based breathing exercises. Each exercise consists of box breathing for 1 minute and participants are instructed to complete 10 sessions corresponding to 10 minutes per day. | Behavioural | Headspace Breathing Exercises |
| Headspace Stress Program20-day smartphone-based mindfulness intervention consisting of 15 minutes per day. The Stress program content is based on well-established concepts and practices within stress management, and mindfulness, and is targeted to people with elevated stress. | Behavioural | Headspace Stress Program |
| Active Control (Audiobook)30-day smartphone-based Audiobook book consisting of 10 minutes per day. | Behavioural | Active Control (Audiobook) |
Primary outcome
Perceived Stress Scale (PSS-10)
Time frame: immediately post intervention
Heart rate variability (HRV)
Time frame: immediately post intervention
HRV data will be recorded continuously during a rest period, acute stress period*, and recovery period at both pre and post on a subject-by-subject basis. *The study will use an acute stress manipulation, specifically the CPT (Cold Pressor Task). The CPT is a standardized physiological acute stressor which has been shown to induce stress, reflected in autonomic stress reactivity (e.g. Lupien et al., 2007; Raio et al., 2017).
2 secondary outcomes
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: immediately post intervention
Mindful Attention Awareness Scale (MAAS)
Time frame: immediately post intervention
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 22 Feb 2024.
- BackgroundCohen, S., & Janicki-Deverts, D. (2012), Who's Stressed? Distributions of Psychological Stress in the United States in Probability Samples from 1983, 2006, and 2009. Journal of Applied Social Psychology, 42: 1320-1334. https://doi.org/10.1111/j.1559-1816.2012.00900.x
- Background: PubMed 35663363Tian F, Shen Q, Hu Y, Ye W, Valdimarsdottir UA, Song H, Fang F. Association of stress-related disorders with subsequent risk of all-cause and cause-specific mortality: A population-based and sibling-controlled cohort study. Lancet Reg Health Eur. 2022 May 28;18:100402. doi: 10.1016/j.lanepe.2022.100402. eCollection 2022 Jul.
- BackgroundWorld Health Organization. The impact of COVID-19 on mental, neurological and substance use services: results of rapid assessment. Geneva: World Health Organization; 2020. Available from: https://www.who.int/publications-detail-redirect/978924012455
- Background: PubMed 33822737Sorkin DH, Janio EA, Eikey EV, Schneider M, Davis K, Schueller SM, Stadnick NA, Zheng K, Neary M, Safani D, Mukamel DB. Rise in Use of Digital Mental Health Tools and Technologies in the United States During the COVID-19 Pandemic: Survey Study. J Med Internet Res. 2021 Apr 16;23(4):e26994. doi: 10.2196/26994.
- Background: PubMed 35551058Philippe TJ, Sikder N, Jackson A, Koblanski ME, Liow E, Pilarinos A, Vasarhelyi K. Digital Health Interventions for Delivery of Mental Health Care: Systematic and Comprehensive Meta-Review. JMIR Ment Health. 2022 May 12;9(5):e35159. doi: 10.2196/35159.
- Background: PubMed 28973957Raio CM, Hartley CA, Orederu TA, Li J, Phelps EA. Stress attenuates the flexible updating of aversive value. Proc Natl Acad Sci U S A. 2017 Oct 17;114(42):11241-11246. doi: 10.1073/pnas.1702565114. Epub 2017 Oct 2.
- Background: PubMed 17466428Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. doi: 10.1016/j.bandc.2007.02.007. Epub 2007 Apr 26.
- Derived from this study: PubMed 37831493Kirk U, Staiano W, Hu E, Ngnoumen C, Kunkle S, Shih E, Clausel A, Purvis C, Lee L. App-Based Mindfulness for Attenuation of Subjective and Physiological Stress Reactivity in a Population With Elevated Stress: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Oct 13;11:e47371. doi: 10.2196/47371.
- Individual participant dataSharing planned: No
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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.
Ulrich Kirk, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headspace Basics Program, Headspace Breathing Exercises and Headspace Stress Program in people with Psychological Stress and Physiological Stress, run by University of Southern Denmark at 1 site in Denmark.
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 3 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 22 Feb 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 Denmark. 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?
Perceived Stress Scale (PSS-10) (time frame: immediately post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832632, which also lists 8 linked publications.
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 22 Feb 2024.