- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02535598
Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Uppsala, Sverige, 75105
- Uppsala University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Normal presentation
Standard internet based CBT presentation.
|
All the material will be presented as plain text.
|
Eksperimentel: Enhanced presentation
Enhanced internet CBT presentation.
|
The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.
|
Aktiv komparator: Normal support
Standard internet based CBT support.
|
Participants receive semi-standardized support once a week and there will be no formal training or competence.
|
Eksperimentel: Enhanced support
Enhanced internet CBT support.
|
Participants are offered daily support through the internet from trained therapists.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of treatment components completed
Tidsramme: Four weeks after treatment start
|
Four weeks after treatment start
|
Number of behavioral prescriptions completed
Tidsramme: Four weeks after treatment start
|
Four weeks after treatment start
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Perceived Stress Scale
Tidsramme: Baseline and four weeks after treatment start
|
Baseline and four weeks after treatment start
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Perceived Stress Scale
Tidsramme: Baseline and eight weeks after treatment start
|
Baseline and eight weeks after treatment start
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Timo Hursti, PhD, Uppsala University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- sveal1031
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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