- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01242865
Self Help Intervention to Decrease Stress
Self Help Intervention to Decrease Stress: A Pilot Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
To assess the feasibility of testing a self help stress management program for improving stress in a pilot clinical trial.
Délai: 12 Weeks
|
12 Weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
To assess the efficacy of the self help stress management program on resilience.
Délai: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on stress.
Délai: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on anxiety.
Délai: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on mindfulness.
Délai: 12 Weeks
|
12 Weeks
|
|
To assess the efficacy of the self help stress management program on overall quality of life.
Délai: 12 Weeks
|
12 Weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Brent A. Bauer, MD, Mayo Clinic
Publications et liens utiles
Publications générales
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10-006367
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