The Stress Reduction Intervention Study

NCT02894229 | Unknown

• 1 other identifier: 16F18
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress, Physiological; Stress, Psychological

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Post-intervention (approximately 7-14 weeks after baseline assessment)

Secondary Outcomes (24)

• Cardiovascular response to repeated acute psychosocial stress

  Post-intervention (approximately 7-14 weeks after baseline assessment)

• Autonomic response to repeated acute psychosocial stress

  Post-intervention (approximately 7-14 weeks after baseline assessment)

• Dispositional Mindfulness

  Baseline and 6-weeks

• Equanimity

  Baseline and 6-weeks

• Smoking

  Baseline and 6-weeks

Study Arms (3)

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

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

Behavioral: Cognitive-Behavioral Therapy (CBT) Group

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

A modified version of traditional MBSR. The current study's version of MBSR is shortened to 6-weeks.

Mindfulness Based Stress Reduction(MBSR)

Cognitive-Behavioral Therapy (CBT) Group BEHAVIORAL

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).

Cognitive Behavioral Therapy (CBT) Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead

Related Publications (1)

• 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.

  PMID: 33630641 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction; Cognitive Behavioral Therapy; Population Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 9, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share