- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02535598
Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This study centers on people with mild symptoms of stress or worry. Participants are recruited by advertisement and the web. Potential participants are contacted by phone and informed about the study. Written informed consent is collected through mail from those who are interested in participating. They are asked to answer all the instruments of the study via a secure internet portal used for delivering the intervention. If they do not fulfill the exclusion criteria they are randomized to one of four conditions. When the intervention has ended participants are asked to fill out all the instruments and again at four week follow up. To find significant (p<.05) results on the primary outcome variables with estimated medium effect sizes, pair-wise comparisons, a power of .80 and allowing for 10% attrition, forty participants are needed in each condition.
The intervention used in this project will be a standard program of applied relaxation that has been used and empirically tested in previous clinical studies. Since the aim of the present project is to investigate factors that affect adherence rather than the intervention effect, the investigators will use a well tested intervention with known effects on symptoms of stress and anxiety. Previous studies have shown that self help with applied relaxation can have a positive effect on for example stress, anxiety and sleep. By providing an intervention that is beneficial, credible and relevant for people with mild symptoms of stress and anxiety it would be possible to investigate how manipulating different factors of the intervention affects the adherence. Applied relaxation will in this intervention consist of a four-week program provided via the Internet. The exact composition of the intervention will be slightly different in each condition depending on the research question, see below. The program includes four steps; tension sensitivity training, long relaxation, short relaxation and applied relaxation. Each week includes information, assignments and support via the secure internet portal.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Uppsala, Suède, 75105
- Uppsala University
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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:
- Self-reported mild to moderate symptoms of stress or worry
Exclusion Criteria:
- insufficient mastery of Swedish language
- elevated symptoms of anxiety or depression that warrant clinical care
- other medical or mental illness that need immediate clinical attention
- no daily access to computer, internet and cell phone
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Normal presentation
Standard internet based CBT presentation.
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All the material will be presented as plain text.
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Expérimental: Enhanced presentation
Enhanced internet CBT presentation.
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The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.
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Comparateur actif: Normal support
Standard internet based CBT support.
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Participants receive semi-standardized support once a week and there will be no formal training or competence.
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Expérimental: Enhanced support
Enhanced internet CBT support.
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Participants are offered daily support through the internet from trained therapists.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Number of treatment components completed
Délai: Four weeks after treatment start
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Four weeks after treatment start
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Number of behavioral prescriptions completed
Délai: Four weeks after treatment start
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Four weeks after treatment start
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Perceived Stress Scale
Délai: Baseline and four weeks after treatment start
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Baseline and four weeks after treatment start
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Autres mesures de résultats
Mesure des résultats |
Délai |
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Perceived Stress Scale
Délai: Baseline and eight weeks after treatment start
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Baseline and eight weeks after treatment start
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Timo Hursti, PhD, Uppsala University
Publications et liens utiles
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
Autres numéros d'identification d'étude
- sveal1031
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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