Self Help Intervention to Decrease Stress

Stress, Psychological Clinical Trial

Official title:

Self Help Intervention to Decrease Stress: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242865
• Other study ID #: 10-006367
• Status: Completed
• Phase: N/A
• First received: November 11, 2010
• Last updated: April 24, 2013
• Start date: December 2010
• Est. completion date: January 2012

Study information

• Verified date: April 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/P

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.		12 Weeks	No
Secondary	To assess the efficacy of the self help stress management program on resilience.		12 Weeks	No
Secondary	To assess the efficacy of the self help stress management program on stress.		12 Weeks	No
Secondary	To assess the efficacy of the self help stress management program on anxiety.		12 Weeks	No
Secondary	To assess the efficacy of the self help stress management program on mindfulness.		12 Weeks	No
Secondary	To assess the efficacy of the self help stress management program on overall quality of life.		12 Weeks	No