Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Uppsala, Svezia, 75105
- Uppsala University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Normal presentation
Standard internet based CBT presentation.
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All the material will be presented as plain text.
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Sperimentale: 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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Comparatore attivo: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Number of treatment components completed
Lasso di tempo: Four weeks after treatment start
|
Four weeks after treatment start
|
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Number of behavioral prescriptions completed
Lasso di tempo: Four weeks after treatment start
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Four weeks after treatment start
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Perceived Stress Scale
Lasso di tempo: Baseline and four weeks after treatment start
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Baseline and four weeks after treatment start
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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
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Perceived Stress Scale
Lasso di tempo: Baseline and eight weeks after treatment start
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Baseline and eight weeks after treatment start
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Timo Hursti, PhD, Uppsala University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- sveal1031
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .