Stress, PhysiologicalNCT02894229
The Stress Reduction Intervention Study
A study testing Mindfulness Based Stress Reduction and Cognitive-Behavioral Therapy (CBT) Group in people with Stress, Physiological and Stress, Psychological, run by Ohio University.
Trial summary
The primary purpose of the present study is to investigate the relationship between mindfulness and stress habituation. The investigators propose to measure the effect of mindfulness on stress habituation by randomly assigning participants to a 6-week mindfulness-based stress reduction group intervention, a… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological, Stress, Psychological
- What is being tested?
- Mindfulness Based Stress Reduction and Cognitive-Behavioral Therapy (CBT) Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jul 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-speaking adults who are between the ages of 18-50, who are in general good health
- Perceived stress scores (PSS) > 3 on a screening survey
Who cannot join
- reported previous completion of a Mindfulness-Based Stress Reduction or Cognitive Behavioral Therapy program.
- reported pregnancy
- reported use of steroid medication
- presence of a major psychiatric or endocrine disorder (e.g., Major Depression, Cushings Disease; self-reported)
- reported regular wake time after 10:00 AM on a weekday
About this study
Official title: The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study
The primary purpose of the present study is to investigate the relationship between mindfulness and stress habituation. The investigators propose to measure the effect of mindfulness on stress habituation by randomly assigning participants to a 6-week mindfulness-based stress reduction group intervention, a cognitive-behavioral skills group comparison intervention, or a waitlist control condition followed by repeated acute psychosocial stress testing (2 laboratory sessions on 2 separate days). Saliva will be collected from participants throughout both laboratory testing sessions to measure HPA axis activation (an essential stress-responsive system), along with other measures of physiological and psychological stress (e.g., heart rate, blood pressure, emotions). Mediators and moderators of treatment outcome will be examined. The cognitive-behavioral skills group condition is an appropriate comparison group due to the well-documented efficacy of cognitive-behavioral interventions on stress.
- Conditions
- Stress, Physiological, Stress, Psychological
- Being tested
- Mindfulness Based Stress Reduction, Cognitive-Behavioral Therapy (CBT) Group
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
A modified version of traditional MBSR. The current study's version of MBSR is shortened to 6-weeks.
Cognitive-Behavioral Therapy (CBT) GroupBehavioural
A 6-week, 2-hour per group, skills group that focuses on various cognitive-behavioral skills for stress reduction (e.g., progressive muscle relaxation; cognitive restructuring).
| Study group | Role | What they receive |
|---|---|---|
| No intervention wait-list | No intervention | This arm will receive no intervention for approximately the first 4 months. At the conclusion of the 4-month period, this group will receive a 6-week cognitive-behavioral therapy (CBT) group |
| Mindfulness Based Stress Reduction(MBSR) | Active comparator | This arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction Receives: Behavioral: Mindfulness Based Stress Reduction |
| Cognitive Behavioral Therapy (CBT) Group | Active comparator | This are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress Receives: Behavioral: Cognitive-Behavioral Therapy (CBT) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
A 10-item self-report measure that examines perceived stress. The measure produces one total score. The investigators will measure the change in total score from baseline to the 6-week assessment.
Measured: Baseline and 6-weeks after baseline.
Salivary cortisol response to repeated acute psychosocial stress
4 saliva samples will be collected before and after a psychosocial stressor task, which will be administered on two separate occasions separated in time by at least 48 hours. All saliva samples will be assayed for salivary cortisol using enzyme-linked immunoassays. The investigators will measure the change in cortisol stress profiles from the first stressor exposure to the second.
Measured: Post-intervention (approximately 7-14 weeks after baseline assessment)
Secondary outcomes (24)
Cardiovascular response to repeated acute psychosocial stress
Heart rate and blood pressure will be assessed non-invasively and periodically before, during, and after non-invasively a psychosocial stressor task, with an Omron Health Care HEM-907XL Professional Blood Pressure Monitor. The investigators will measure the change in heart rate and blood pressure stress profiles from the first stressor exposure to the second.
Measured: Post-intervention (approximately 7-14 weeks after baseline assessment)
Autonomic response to repeated acute psychosocial stress
Heart rate variability will be assessed continuously before, during, and after non-invasively a psychosocial stressor task, with a MP150 device manufactured by BIOPAC. The investigators will measure the change in heart rate variability stress profiles from the first stressor exposure to the second.
Measured: Post-intervention (approximately 7-14 weeks after baseline assessment)
Dispositional Mindfulness
Five Facet Mindfulness Questionnaire
Measured: Baseline and 6-weeks
Equanimity
The Non-Attachment Scale
Measured: Baseline and 6-weeks
Smoking
Fagerstrom Test for Nicotine Dependence
Measured: Baseline and 6-weeks
Alcohol
Alcohol Use Disorders Identification Test - Consumption items
Measured: Baseline and 6-weeks
Marijuana
Single item assessing frequency of marijuana use
Measured: Baseline and 6-weeks
Perceived control over thoughts
Thought Control Ability Questionnaire
Measured: Baseline and 6 weeks
Coping Skills
Brief-COPE measure
Measured: Baseline and 6-weeks
Depressed mood
Center for Epidemiologic Studies Depression Scale
Measured: Baseline and 6-weeks
Anxiety
Spielberger State-Trait Anxiety Inventory
Measured: Baseline and 6-weeks later
Social Connectedness
Social Connectedness Scale-Revised
Measured: Baseline and 6-weeks
Optimism
Life Orientation Test
Measured: Baseline and 6-weeks
Worry
Penn State Worry Questionnaire
Measured: Baseline and 6-weeks
Experiential Avoidance
Acceptance and Action Questionnaire-II
Measured: Baseline and 6-weeks
Emotion Regulation
Difficulties in Emotion Regulation Scale
Measured: Baseline and 6-weeks
Negative Urgency
UPPS-P Impulsive Behavior Scale: Negative Urgency Items
Measured: Baseline and 6-weeks
Chronic Stress
Trier Inventory for Chronic Stress
Measured: Baseline and 6-weeks
Sleep
Pittsburgh Sleep Quality Index
Measured: Baseline and 6-weeks
State Affect
Positive and Negative Affect Schedule (PANAS) will be used to assess state affect and specific emotions several times before and after a psychosocial stressor task. The investigators will measure the change in emotion response profiles from the first stressor exposure to the second.
Measured: Post-intervention (approximately 7-14 weeks after baseline assessment)
State mindfulness
Mindful Attention Awareness Scale (MAAS) - state version. The investigators will measure the change in state mindfulness from the first stressor exposure to the second.
Measured: Post-intervention (approximately 7-14 weeks after baseline assessment)
Implicit association between self and shame
A shame experience and self implicit association test will be used to measure experiential self-referential processing of present moment shame. The investigators will measure the change in implicit association between self and shame from the first stressor exposure to the second.
Measured: Post-intervention (approximately 7-14 weeks after baseline assessment)
State rumination
Thoughts Questionnaire (TQ). The investigators will measure the change in state rumination from the first stressor exposure to the second.
Measured: Post-intervention (approximately 7-14 weeks after baseline assessment)
Stress appraisals
Cognitive task appraisals will be assessed before and after a psychosocial stressor task. The investigators will measure the change in appraisals from the first stressor exposure to the second.
Measured: Post-intervention (approximately 7-14 weeks after baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PhysiologicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894229
- Sponsor's protocol ID
- 16F18
- Status last verified
- Apr 2018
- First submitted
- 5 Sep 2016
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Manigault AW, Shorey RC, Decastro G, Appelmann HM, Hamilton KR, Scanlin MC, France CR, Zoccola PM. Standardized stress reduction interventions and blood pressure habituation: Secondary results from a randomized controlled trial. Health Psychol. 2021 Mar;40(3):196-206. doi: 10.1037/hea0000954.
PubMed 33630641
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study
- ClinicalTrials.gov ID
- NCT02894229
- Acronym / sponsor ID
- 16F18
- Conditions
- Stress, Physiological, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- 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.
The primary purpose of the present study is to investigate the relationship between mindfulness and stress habituation. The investigators propose to measure the effect of mindfulness on stress habituation by randomly assigning participants to a 6-week mindfulness-based stress reduction group intervention, a cognitive-behavioral skills group comparison intervention, or a waitlist control condition followed by repeated acute psychosocial stress testing (2 laboratory sessions on 2 separate days). Saliva will be collected from participants throughout both laboratory testing sessions to measure HPA axis activation (an essential stress-responsive system), along with other measures of physiological and psychological stress (e.g., heart rate, blood pressure, emotions). Mediators and moderators of treatment outcome will be examined. The cognitive-behavioral skills group condition is an appropriate comparison group due to the well-documented efficacy of cognitive-behavioral interventions on stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention wait-list | No intervention | –This arm will receive no intervention for approximately the first 4 months. At the conclusion of the 4-month period, this group will receive a 6-week cognitive-behavioral therapy (CBT) group |
| Mindfulness Based Stress Reduction(MBSR) | Active comparator | Behavioral: Mindfulness Based Stress ReductionThis arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction |
| Cognitive Behavioral Therapy (CBT) Group | Active comparator | Behavioral: Cognitive-Behavioral Therapy (CBT) GroupThis are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English-speaking adults who are between the ages of 18-50, who are in general good health
- Perceived stress scores (PSS) > 3 on a screening survey
Key exclusion criteria (5 listed)
- reported previous completion of a Mindfulness-Based Stress Reduction or Cognitive Behavioral Therapy program.
- reported pregnancy
- reported use of steroid medication
- presence of a major psychiatric or endocrine disorder (e.g., Major Depression, Cushings Disease; self-reported)
- reported regular wake time after 10:00 AM on a weekday
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 |
|---|---|---|
| Mindfulness Based Stress ReductionA modified version of traditional MBSR. The current study's version of MBSR is shortened to 6-weeks. | Behavioural | Mindfulness Based Stress Reduction(MBSR) |
| Cognitive-Behavioral Therapy (CBT) GroupA 6-week, 2-hour per group, skills group that focuses on various cognitive-behavioral skills for stress reduction (e.g., progressive muscle relaxation; cognitive restructuring). | Behavioural | Cognitive Behavioral Therapy (CBT) Group |
Primary outcome
Perceived Stress Scale
Time frame: Baseline and 6-weeks after baseline.
A 10-item self-report measure that examines perceived stress. The measure produces one total score. The investigators will measure the change in total score from baseline to the 6-week assessment.
Salivary cortisol response to repeated acute psychosocial stress
Time frame: Post-intervention (approximately 7-14 weeks after baseline assessment)
4 saliva samples will be collected before and after a psychosocial stressor task, which will be administered on two separate occasions separated in time by at least 48 hours. All saliva samples will be assayed for salivary cortisol using enzyme-linked immunoassays. The investigators will measure the change in cortisol stress profiles from the first stressor exposure to the second.
24 secondary outcomes
Cardiovascular response to repeated acute psychosocial stress
Time frame: Post-intervention (approximately 7-14 weeks after baseline assessment)
Autonomic response to repeated acute psychosocial stress
Time frame: Post-intervention (approximately 7-14 weeks after baseline assessment)
Dispositional Mindfulness
Time frame: Baseline and 6-weeks
Equanimity
Time frame: Baseline and 6-weeks
Smoking
Time frame: Baseline and 6-weeks
Alcohol
Time frame: Baseline and 6-weeks
Marijuana
Time frame: Baseline and 6-weeks
Perceived control over thoughts
Time frame: Baseline and 6 weeks
Coping Skills
Time frame: Baseline and 6-weeks
Depressed mood
Time frame: Baseline and 6-weeks
Anxiety
Time frame: Baseline and 6-weeks later
Social Connectedness
Time frame: Baseline and 6-weeks
Optimism
Time frame: Baseline and 6-weeks
Worry
Time frame: Baseline and 6-weeks
Experiential Avoidance
Time frame: Baseline and 6-weeks
Emotion Regulation
Time frame: Baseline and 6-weeks
Negative Urgency
Time frame: Baseline and 6-weeks
Chronic Stress
Time frame: Baseline and 6-weeks
Sleep
Time frame: Baseline and 6-weeks
State Affect
Time frame: Post-intervention (approximately 7-14 weeks after baseline assessment)
State mindfulness
Time frame: Post-intervention (approximately 7-14 weeks after baseline assessment)
Implicit association between self and shame
Time frame: Post-intervention (approximately 7-14 weeks after baseline assessment)
State rumination
Time frame: Post-intervention (approximately 7-14 weeks after baseline assessment)
Stress appraisals
Time frame: Post-intervention (approximately 7-14 weeks after baseline assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Derived from this study: PubMed 33630641Manigault AW, Shorey RC, Decastro G, Appelmann HM, Hamilton KR, Scanlin MC, France CR, Zoccola PM. Standardized stress reduction interventions and blood pressure habituation: Secondary results from a randomized controlled trial. Health Psychol. 2021 Mar;40(3):196-206. doi: 10.1037/hea0000954.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction and Cognitive-Behavioral Therapy (CBT) Group in people with Stress, Physiological and Stress, Psychological, run by Ohio University.
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 5 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: status not confirmed, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 (time frame: Baseline and 6-weeks after baseline.). 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 NCT02894229, which also lists 1 linked publication.
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 4 Apr 2018.