This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ohio University
ClinicalTrials.gov Identifier:
NCT02894229
First received: September 5, 2016
Last updated: September 8, 2016
Last verified: September 2016
The primary purpose of the present study is to investigate the relationship between mindfulness and stress habituation. We 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 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.
| Stress, Physiological Stress, Psychological |
Behavioral: Mindfulness Based Stress Reduction Behavioral: Cognitive-Behavioral Therapy (CBT) Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
- Perceived Stress Scale [ Time Frame: Baseline and 6-weeks after baseline. ] [ Designated as safety issue: No ]
A 10-item self-report measure that examines perceived stress. The measure produces one total score. We 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) ] [ Designated as safety issue: No ]
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. We will measure the change in cortisol stress profiles from the first stressor exposure to the second.
- Cardiovascular response to repeated acute psychosocial stress [ Time Frame: Post-intervention (approximately 7-14 weeks after baseline assessment) ] [ Designated as safety issue: No ]
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. We 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 [ Time Frame: Post-intervention (approximately 7-14 weeks after baseline assessment) ] [ Designated as safety issue: No ]
Heart rate variability will be assessed continuously before, during, and after non-invasively a psychosocial stressor task, with a MP150 device manufactured by BIOPAC. We will measure the change in heart rate variability stress profiles from the first stressor exposure to the second.
- Dispositional Mindfulness [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Five Facet Mindfulness Questionnaire
- Equanimity [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
The Non-Attachment Scale
- Smoking [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Fagerstrom Test for Nicotine Dependence
- Alcohol [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Alcohol Use Disorders Identification Test – Consumption items
- Marijuana [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Single item assessing frequency of marijuana use
- Perceived control over thoughts [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
Thought Control Ability Questionnaire
- Coping Skills [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Brief-COPE measure
- Depressed mood [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Center for Epidemiologic Studies Depression Scale
- Anxiety [ Time Frame: Baseline and 6-weeks later ] [ Designated as safety issue: No ]
Spielberger State-Trait Anxiety Inventory
- Social Connectedness [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Social Connectedness Scale-Revised
- Optimism [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Life Orientation Test
- Worry [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Penn State Worry Questionnaire
- Experiential Avoidance [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Acceptance and Action Questionnaire-II
- Emotion Regulation [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Difficulties in Emotion Regulation Scale
- Negative Urgency [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
UPPS-P Impulsive Behavior Scale: Negative Urgency Items
- Chronic Stress [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Trier Inventory for Chronic Stress
- Sleep [ Time Frame: Baseline and 6-weeks ] [ Designated as safety issue: No ]
Pittsburgh Sleep Quality Index
- State Affect [ Time Frame: Post-intervention (approximately 7-14 weeks after baseline assessment) ] [ Designated as safety issue: No ]
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. We will measure the change in emotion response profiles from the first stressor exposure to the second.
- State mindfulness [ Time Frame: Post-intervention (approximately 7-14 weeks after baseline assessment) ] [ Designated as safety issue: No ]
Mindful Attention Awareness Scale (MAAS) – state version. We will measure the change in state mindfulness from the first stressor exposure to the second.
- Implicit association between self and shame [ Time Frame: Post-intervention (approximately 7-14 weeks after baseline assessment) ] [ Designated as safety issue: No ]
A shame experience and self implicit association test will be used to measure experiential self-referential processing of present moment shame. We will measure the change in implicit association between self and shame from the first stressor exposure to the second.
- State rumination [ Time Frame: Post-intervention (approximately 7-14 weeks after baseline assessment) ] [ Designated as safety issue: No ]
Thoughts Questionnaire (TQ). We will measure the change in state rumination from the first stressor exposure to the second.
- Stress appraisals [ Time Frame: Post-intervention (approximately 7-14 weeks after baseline assessment) ] [ Designated as safety issue: No ]
Cognitive task appraisals will be assessed before and after a psychosocial stressor task. We will measure the change in appraisals from the first stressor exposure to the second.
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2016 |
| Estimated Study Completion Date: | July 2019 |
| Estimated Primary Completion Date: | July 2019 (Final data collection date for primary outcome measure) |
| No Intervention: No intervention wait-list
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 stress intervention (CBT) |
|
| Active Comparator: Mindfulness Based Stress Reduction (MBSR)
This arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction |
Behavioral: Mindfulness Based Stress Reduction
A modified version of traditional MBSR. The current study’s version of MBSR is shortened to 6-weeks. |
| Active Comparator: Cognitive Behavioral Therapy (CBT) Group
This are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress |
Behavioral: Cognitive-Behavioral Therapy (CBT) Group
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). |
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
No Contacts or Locations Provided
| Responsible Party: | Ohio University |
| ClinicalTrials.gov Identifier: | NCT02894229 History of Changes |
| Other Study ID Numbers: | 16F18 |
| Study First Received: | September 5, 2016 |
| Last Updated: | September 8, 2016 |
| Health Authority: | United States: Institutional Review Board |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
| Stress, Psychological Behavioral Symptoms |
ClinicalTrials.gov processed this record on September 08, 2016