Self Help Intervention to Decrease Stress

Self Help Intervention to Decrease Stress: A Pilot Trial

The present study is designed to test the feasibility and efficacy of a stand alone self help program for decreasing stress and anxiety and enhancing quality of life. The intervention will be offered in the form of a self help book and three handouts with no in-person instructor time.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological
• Intervention / Treatment: Behavioral: Attention and Interpretation Therapy

Detailed Description

Stress is a ubiquitous problem and a mediator of symptoms for a variety of medical conditions. Most medical diagnoses, procedures, and physician visits are associated with considerable stress. Excessive stress is associated with adverse medical outcomes, unhealthy coping mechanisms, symptoms of anxiety and depression, and overall a poor quality of life. No specific pharmacologic treatment is available for treating stress. Further, it is often difficult or sometimes impossible to change the reality of circumstances causing stress in an individual. Thus increasing individual coping mechanisms and ability of a person to handle stress, rather than changing the stressors itself might be a more feasible approach towards reducing stress.

Several interventions are available to decrease stress. Majority of these programs entail extensive in-person training which impacts on widespread dissemination of the program. We are interested in applying an innovative approach toward stress management by testing the efficacy of a stand alone self help program offered in the form of a book with no in-person instructor time. Participants will receive a copy of the book, "Train Your Brain Engage Your Heart Transform Your Life" along with three handouts summarizing the contents of the book. This book describes the program of Attention and Interpretation therapy that is designed to help decrease stress and anxiety and has been developed at Mayo Clinic Rochester.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• At least 18 years of age
• Good general health
• Provided with, understand, and have signed the informed consent

Exclusion criteria:

• Are currently using (at time of enrollment) antipsychotics and/or antidepressants
• Have a life time history of schizophrenia.
• Previously participated in Attention and Interpretation Therapy (AIT) training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Attention and Interpretation Therapy	Behavioral: Attention and Interpretation Therapy; Participants will receive a copy of the book, "Train Your Brain Engage Your Heart Transform Your Life" along with three handouts summarizing the contents of the book.; Other Names: AIT; Stress Management Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the efficacy of the self help stress management program on resilience.	12 Weeks
To assess the efficacy of the self help stress management program on stress.	12 Weeks
To assess the efficacy of the self help stress management program on anxiety.	12 Weeks
To assess the efficacy of the self help stress management program on mindfulness.	12 Weeks
To assess the efficacy of the self help stress management program on overall quality of life.	12 Weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brent A. Bauer, MD, Mayo Clinic

Publications and helpful links

General Publications

• Sharma V, Bauer B, Prasad K, Sood A, Schroeder D. P02.197. Self help intervention to decrease stress and increase mindfulness: a pilot trial. BMC Complementary and Alternative Medicine 2012, 12(Suppl 1):P253. http://www.biomedcentral.com/1472-6882/12/S1/P253

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: November 11, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (Estimate): November 17, 2010

Study Record Updates

• Last Update Posted (Estimate): April 26, 2013
• Last Update Submitted That Met QC Criteria: April 24, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Quality of Life; Anxiety; Stress; Mindfulness; Stress Management; Resilience
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 10-006367