Therapy Labs: To Improve Adherence in Internet Based Psychotherapy

Behavior Therapy Clinical Trial

Official title:

Therapy Labs: To Improve Adherence in Internet Based Psychotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535598
• Other study ID #: sveal1031
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: May 12, 2016
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: September 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Behavior Therapy

Intervention

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

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived Stress Scale		Baseline and eight weeks after treatment start	No
Primary	Number of treatment components completed		Four weeks after treatment start	No
Primary	Number of behavioral prescriptions completed		Four weeks after treatment start	No
Secondary	Perceived Stress Scale		Baseline and four weeks after treatment start	No