Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Uppsala, Schweden, 75105
- Uppsala University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Normal presentation
Standard internet based CBT presentation.
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All the material will be presented as plain text.
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Experimental: 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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Aktiver Komparator: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Number of treatment components completed
Zeitfenster: Four weeks after treatment start
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Four weeks after treatment start
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Number of behavioral prescriptions completed
Zeitfenster: Four weeks after treatment start
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Four weeks after treatment start
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Perceived Stress Scale
Zeitfenster: Baseline and four weeks after treatment start
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Baseline and four weeks after treatment start
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Perceived Stress Scale
Zeitfenster: Baseline and eight weeks after treatment start
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Baseline and eight weeks after treatment start
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Timo Hursti, PhD, Uppsala University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- sveal1031
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