- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01242865
Self Help Intervention to Decrease Stress
Self Help Intervention to Decrease Stress: A Pilot Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.
Tidsramme: 12 Weeks
|
12 Weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To assess the efficacy of the self help stress management program on resilience.
Tidsramme: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on stress.
Tidsramme: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on anxiety.
Tidsramme: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on mindfulness.
Tidsramme: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on overall quality of life.
Tidsramme: 12 Weeks
|
12 Weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Brent A. Bauer, MD, Mayo Clinic
Publikationer og nyttige links
Generelle publikationer
- 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
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10-006367
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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