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Self Help Intervention to Decrease Stress

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention and Interpretation Therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Stress, Anxiety, Resilience, Mindfulness, Quality of Life, Stress Management

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Attention and Interpretation Therapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the efficacy of the self help stress management program on resilience.
To assess the efficacy of the self help stress management program on stress.
To assess the efficacy of the self help stress management program on anxiety.
To assess the efficacy of the self help stress management program on mindfulness.
To assess the efficacy of the self help stress management program on overall quality of life.

Full Information

First Posted
November 11, 2010
Last Updated
April 24, 2013
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01242865
Brief Title
Self Help Intervention to Decrease Stress
Official Title
Self Help Intervention to Decrease Stress: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Stress, Anxiety, Resilience, Mindfulness, Quality of Life, Stress Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention and Interpretation Therapy
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Attention and Interpretation Therapy
Other Intervention Name(s)
AIT, Stress Management Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To assess the efficacy of the self help stress management program on resilience.
Time Frame
12 Weeks
Title
To assess the efficacy of the self help stress management program on stress.
Time Frame
12 Weeks
Title
To assess the efficacy of the self help stress management program on anxiety.
Time Frame
12 Weeks
Title
To assess the efficacy of the self help stress management program on mindfulness.
Time Frame
12 Weeks
Title
To assess the efficacy of the self help stress management program on overall quality of life.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent A. Bauer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
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
Results Reference
result

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Self Help Intervention to Decrease Stress

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