NCT01242865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

1.1 years

First QC Date

November 11, 2010

Last Update Submit

April 24, 2013

Conditions

Keywords

StressAnxietyResilienceMindfulnessQuality of LifeStress Management

Outcome Measures

Primary Outcomes (1)

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

    12 Weeks

Secondary Outcomes (5)

  • 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

Study Arms (1)

Attention and Interpretation Therapy

OTHER
Behavioral: Attention and Interpretation Therapy

Interventions

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.

Also known as: AIT, Stress Management Program
Attention and Interpretation Therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Good general health
  • Provided with, understand, and have signed the informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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/P253

    RESULT

MeSH Terms

Conditions

Stress, PsychologicalAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Brent A. Bauer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2010

First Posted

November 17, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations