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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
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Physiological

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 5, 2016
    Last Updated
    April 3, 2018
    Sponsor
    Ohio University
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    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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