NCT02535598

Therapy Labs: To Improve Adherence in Internet Based Psychotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Behavior Therapy

Interventions

Type	Name	Description
BEHAVIORAL	Normal presentation	All the material will be presented as plain text.
BEHAVIORAL	Enhanced presentation	The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.
BEHAVIORAL	Normal support	Participants receive semi-standardized support once a week and there will be no formal training or competence.
BEHAVIORAL	Enhanced support	Participants are offered daily support through the internet from trained therapists.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-01-01
• Completion: 2015-09-01
• First posted: 2015-08-28
• Last updated: 2016-05-13

Locations

1 site across 1 country: Sweden