The Stress Reduction Intervention Study

NCT ID: NCT02894229

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 cognitive-behavioral therapy (CBT) group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mindfulness Based Stress Reduction(MBSR)

This arm will receive 6 weekly, 2-hour groups that focuses on mindfulness meditation for stress reduction

Group Type: ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction

Intervention Type: BEHAVIORAL

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

Cognitive Behavioral Therapy (CBT) Group

This are will receive 6 weekly, 2-hour groups that focus on cognitive-behavioral skills for stress

Group Type: ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy (CBT) Group

Intervention Type: 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).

Interventions

Mindfulness Based Stress Reduction

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

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 33630641 (View on PubMed)

Other Identifiers

16F18

Identifier Type: -

Identifier Source: org_study_id