- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01242865
Self Help Intervention to Decrease Stress
Self Help Intervention to Decrease Stress: A Pilot Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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 navn:
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Brent A. Bauer, MD, Mayo Clinic
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10-006367
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