Self Help Intervention to Decrease Stress

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01242865
First received: November 11, 2010
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Stress, Psychological
Behavioral: Attention and Interpretation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self Help Intervention to Decrease Stress: A Pilot Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the efficacy of the self help stress management program on resilience. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of the self help stress management program on stress. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of the self help stress management program on anxiety. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of the self help stress management program on mindfulness. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of the self help stress management program on overall quality of life. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: December 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242865

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Brent A. Bauer, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Brent A. Bauer, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01242865     History of Changes
Other Study ID Numbers: 10-006367
Study First Received: November 11, 2010
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Stress
Anxiety
Resilience
Mindfulness
Quality of Life
Stress Management

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 01, 2014