The Stress Reduction Intervention Study

Ohio University

Status: Unknown

Conditions: Stress, Psychological; Stress, Physiological

Treatments: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Cognitive-Behavioral Therapy (CBT) Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02894229

16F18

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

No intervention wait-list

No Intervention group

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

Mindfulness Based Stress Reduction(MBSR)

Active Comparator group

Description:

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

Treatment:

Behavioral: Mindfulness Based Stress Reduction

Cognitive Behavioral Therapy (CBT) Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive-Behavioral Therapy (CBT) Group