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OpenTrials
Completed

NCT Number: NCT02535598

Therapy Labs: To Improve Adherence in Internet Based Psychotherapy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University

Uppsala, Uppsala County, 75105, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal presentation

Behavioral

All the material will be presented as plain text.

Enhanced presentation

Behavioral

The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.

Normal support

Behavioral

Participants receive semi-standardized support once a week and there will be no formal training or competence.

Enhanced support

Behavioral

Participants are offered daily support through the internet from trained therapists.

Primary outcomes

  1. Number of treatment components completed

    Time frame: Four weeks after treatment start

  2. Number of behavioral prescriptions completed

    Time frame: Four weeks after treatment start

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: Baseline and four weeks after treatment start

Other outcomes

  1. Perceived Stress Scale

    Time frame: Baseline and eight weeks after treatment start

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2015
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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