- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01242865
Self Help Intervention to Decrease Stress
Self Help Intervention to Decrease Stress: A Pilot Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.
Tidsram: 12 Weeks
|
12 Weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
To assess the efficacy of the self help stress management program on resilience.
Tidsram: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on stress.
Tidsram: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on anxiety.
Tidsram: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on mindfulness.
Tidsram: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on overall quality of life.
Tidsram: 12 Weeks
|
12 Weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Brent A. Bauer, MD, Mayo Clinic
Publikationer och användbara länkar
Allmänna 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
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-006367
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