Stress, PsychologicalNCT01242865
Self Help Intervention to Decrease Stress
A study testing Attention and Interpretation Therapy in people with Stress, Psychological, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Attention and Interpretation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Good general health
- Provided with, understand, and have signed the informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self Help Intervention to Decrease Stress: A Pilot Trial
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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- Attention and Interpretation Therapy
- Keywords
- Stress, Anxiety, Resilience, Mindfulness, Quality of Life, Stress Management
- Medical subject headings
- Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention and Interpretation TherapyBehavioural
Also called AIT, Stress Management Program
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention and Interpretation Therapy | Other | Not described Receives: Behavioral: Attention and Interpretation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.
Measured: 12 Weeks
Secondary outcomes (5)
To assess the efficacy of the self help stress management program on resilience.
Measured: 12 Weeks
To assess the efficacy of the self help stress management program on stress.
Measured: 12 Weeks
To assess the efficacy of the self help stress management program on anxiety.
Measured: 12 Weeks
To assess the efficacy of the self help stress management program on mindfulness.
Measured: 12 Weeks
To assess the efficacy of the self help stress management program on overall quality of life.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent A. Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242865
- Sponsor's protocol ID
- 10-006367
- Status last verified
- Apr 2013
- First submitted
- 11 Nov 2010
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Help Intervention to Decrease Stress: A Pilot Trial
- ClinicalTrials.gov ID
- NCT01242865
- Acronym / sponsor ID
- 10-006367
- Conditions
- Stress, Psychological
- Keywords
- Stress, Anxiety, Resilience, Mindfulness, Quality of Life, Stress Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attention and Interpretation Therapy | Other | Behavioral: Attention and Interpretation Therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Good general health
- Provided with, understand, and have signed the informed consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention and Interpretation TherapyAlso: AIT, Stress Management ProgramParticipants 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. | Behavioural | Attention and Interpretation Therapy |
Primary outcome
To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.
Time frame: 12 Weeks
5 secondary outcomes
To assess the efficacy of the self help stress management program on resilience.
Time frame: 12 Weeks
To assess the efficacy of the self help stress management program on stress.
Time frame: 12 Weeks
To assess the efficacy of the self help stress management program on anxiety.
Time frame: 12 Weeks
To assess the efficacy of the self help stress management program on mindfulness.
Time frame: 12 Weeks
To assess the efficacy of the self help stress management program on overall quality of life.
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- Results publicationSharma 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent A. Bauer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention and Interpretation Therapy in people with Stress, Psychological, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01242865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.