The Stress Reduction Intervention Study
Primary Purpose
Stress, Physiological, Stress, Psychological
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Cognitive-Behavioral Therapy (CBT) Group
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Physiological
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
No intervention wait-list
Mindfulness Based Stress Reduction(MBSR)
Cognitive Behavioral Therapy (CBT) Group
Arm Description
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
This arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction
This are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Dispositional Mindfulness
Five Facet Mindfulness Questionnaire
Equanimity
The Non-Attachment Scale
Smoking
Fagerstrom Test for Nicotine Dependence
Alcohol
Alcohol Use Disorders Identification Test - Consumption items
Marijuana
Single item assessing frequency of marijuana use
Perceived control over thoughts
Thought Control Ability Questionnaire
Coping Skills
Brief-COPE measure
Depressed mood
Center for Epidemiologic Studies Depression Scale
Anxiety
Spielberger State-Trait Anxiety Inventory
Social Connectedness
Social Connectedness Scale-Revised
Optimism
Life Orientation Test
Worry
Penn State Worry Questionnaire
Experiential Avoidance
Acceptance and Action Questionnaire-II
Emotion Regulation
Difficulties in Emotion Regulation Scale
Negative Urgency
UPPS-P Impulsive Behavior Scale: Negative Urgency Items
Chronic Stress
Trier Inventory for Chronic Stress
Sleep
Pittsburgh Sleep Quality Index
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.
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.
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.
State rumination
Thoughts Questionnaire (TQ). The investigators will measure the change in state rumination from the first stressor exposure to the second.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02894229
Brief Title
The Stress Reduction Intervention Study
Official Title
The Mindfulness Intervention and Repeated Acute Stress (MIRAS) Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Physiological, Stress, Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No intervention wait-list
Arm Type
No Intervention
Arm Description
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
Arm Title
Mindfulness Based Stress Reduction(MBSR)
Arm Type
Active Comparator
Arm Description
This arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction
Arm Title
Cognitive Behavioral Therapy (CBT) Group
Arm Type
Active Comparator
Arm Description
This are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
A modified version of traditional MBSR. The current study's version of MBSR is shortened to 6-weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy (CBT) Group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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.
Time Frame
Baseline and 6-weeks after baseline.
Title
Salivary cortisol response to repeated acute psychosocial stress
Description
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.
Time Frame
Post-intervention (approximately 7-14 weeks after baseline assessment)
Secondary Outcome Measure Information:
Title
Cardiovascular response to repeated acute psychosocial stress
Description
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.
Time Frame
Post-intervention (approximately 7-14 weeks after baseline assessment)
Title
Autonomic response to repeated acute psychosocial stress
Description
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.
Time Frame
Post-intervention (approximately 7-14 weeks after baseline assessment)
Title
Dispositional Mindfulness
Description
Five Facet Mindfulness Questionnaire
Time Frame
Baseline and 6-weeks
Title
Equanimity
Description
The Non-Attachment Scale
Time Frame
Baseline and 6-weeks
Title
Smoking
Description
Fagerstrom Test for Nicotine Dependence
Time Frame
Baseline and 6-weeks
Title
Alcohol
Description
Alcohol Use Disorders Identification Test - Consumption items
Time Frame
Baseline and 6-weeks
Title
Marijuana
Description
Single item assessing frequency of marijuana use
Time Frame
Baseline and 6-weeks
Title
Perceived control over thoughts
Description
Thought Control Ability Questionnaire
Time Frame
Baseline and 6 weeks
Title
Coping Skills
Description
Brief-COPE measure
Time Frame
Baseline and 6-weeks
Title
Depressed mood
Description
Center for Epidemiologic Studies Depression Scale
Time Frame
Baseline and 6-weeks
Title
Anxiety
Description
Spielberger State-Trait Anxiety Inventory
Time Frame
Baseline and 6-weeks later
Title
Social Connectedness
Description
Social Connectedness Scale-Revised
Time Frame
Baseline and 6-weeks
Title
Optimism
Description
Life Orientation Test
Time Frame
Baseline and 6-weeks
Title
Worry
Description
Penn State Worry Questionnaire
Time Frame
Baseline and 6-weeks
Title
Experiential Avoidance
Description
Acceptance and Action Questionnaire-II
Time Frame
Baseline and 6-weeks
Title
Emotion Regulation
Description
Difficulties in Emotion Regulation Scale
Time Frame
Baseline and 6-weeks
Title
Negative Urgency
Description
UPPS-P Impulsive Behavior Scale: Negative Urgency Items
Time Frame
Baseline and 6-weeks
Title
Chronic Stress
Description
Trier Inventory for Chronic Stress
Time Frame
Baseline and 6-weeks
Title
Sleep
Description
Pittsburgh Sleep Quality Index
Time Frame
Baseline and 6-weeks
Title
State Affect
Description
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.
Time Frame
Post-intervention (approximately 7-14 weeks after baseline assessment)
Title
State mindfulness
Description
Mindful Attention Awareness Scale (MAAS) - state version. The investigators will measure the change in state mindfulness from the first stressor exposure to the second.
Time Frame
Post-intervention (approximately 7-14 weeks after baseline assessment)
Title
Implicit association between self and shame
Description
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.
Time Frame
Post-intervention (approximately 7-14 weeks after baseline assessment)
Title
State rumination
Description
Thoughts Questionnaire (TQ). The investigators will measure the change in state rumination from the first stressor exposure to the second.
Time Frame
Post-intervention (approximately 7-14 weeks after baseline assessment)
Title
Stress appraisals
Description
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.
Time Frame
Post-intervention (approximately 7-14 weeks after baseline assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33630641
Citation
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.
Results Reference
derived
Learn more about this trial
The Stress Reduction Intervention Study
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