An interventional study of Normal presentation and Enhanced presentation in Behavior Therapy, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by Uppsala University · Not applicable and Interventional
This project aims to investigate factors that are important in affecting adherence in internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two intervention-specific variables, Support and Content, are important factors and that maximizing the impact of these would result in improved adherence and potentially in the end also better outcome for participants in internet interventions.
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.
Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard internet based CBT presentation.
Behavioral: Normal presentation
Enhanced internet CBT presentation.
Behavioral: Enhanced presentation
Standard internet based CBT support.
Behavioral: Normal support
Enhanced internet CBT support.
Behavioral: Enhanced support
All the material will be presented as plain text.
The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.
Participants receive semi-standardized support once a week and there will be no formal training or competence.
Participants are offered daily support through the internet from trained therapists.
Number of treatment components completed
Time frame: Four weeks after treatment start
Number of behavioral prescriptions completed
Time frame: Four weeks after treatment start
Perceived Stress Scale
Time frame: Baseline and four weeks after treatment start
Perceived Stress Scale
Time frame: Baseline and eight weeks after treatment start
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Uppsala University