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Therapy Labs: To Improve Adherence in Internet Based Psychotherapy

Not Applicable
Completed
Conditions
Behavior Therapy
Interventions
Behavioral: Normal support
Behavioral: Enhanced support
Behavioral: Normal presentation
Behavioral: Enhanced presentation
Registration Number
NCT02535598
Lead Sponsor
Uppsala University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
169
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Normal supportNormal supportStandard internet based CBT support.
Enhanced supportEnhanced supportEnhanced internet CBT support.
Normal presentationNormal presentationStandard internet based CBT presentation.
Enhanced presentationEnhanced presentationEnhanced internet CBT presentation.
Primary Outcome Measures
NameTimeMethod
Number of behavioral prescriptions completedFour weeks after treatment start
Number of treatment components completedFour weeks after treatment start
Secondary Outcome Measures
NameTimeMethod
Perceived Stress ScaleBaseline and four weeks after treatment start

Trial Locations

Locations (1)

Uppsala University

🇸🇪

Uppsala, Sweden

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