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Clinical Trials/NCT01242865
NCT01242865CompletedNot Applicable

Self Help Intervention to Decrease Stress: A Pilot Trial

Mayo Clinic1 site in 1 country33 target enrollmentStarted: December 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
1
Primary Endpoint
To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Attention and Interpretation Therapy

Other

Intervention: Attention and Interpretation Therapy (Behavioral)

Outcomes

Primary Outcomes

To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.

Time Frame: 12 Weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brent A. Bauer

Principal Investigator

Mayo Clinic

Study Sites (1)

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