Clinical trial NCT01242865: Self Help Intervention to Decrease Stress
Official title: Self Help Intervention to Decrease Stress: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: Stress
Anxiety
Resilience
Mindfulness
Quality of Life
Stress Management
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.
timeFrame: 12 Weeks
Secondary outcomes:
measure: To assess the efficacy of the self help stress management program on resilience.
timeFrame: 12 Weeks
measure: To assess the efficacy of the self help stress management program on stress.
timeFrame: 12 Weeks
measure: To assess the efficacy of the self help stress management program on anxiety.
timeFrame: 12 Weeks
measure: To assess the efficacy of the self help stress management program on mindfulness.
timeFrame: 12 Weeks
measure: To assess the efficacy of the self help stress management program on overall quality of life.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent A. Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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