Clinical trial NCT02535598: Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
Official title: Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Therapy
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of treatment components completed
timeFrame: Four weeks after treatment start
measure: Number of behavioral prescriptions completed
timeFrame: Four weeks after treatment start
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline and four weeks after treatment start
Other outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline and eight weeks after treatment start
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Timo Hursti, PhD
role: STUDY_DIRECTOR
References:
citation: Alfonsson S, Olsson E, Hursti T. Motivation and Treatment Credibility Predicts Dropout, Treatment Adherence, and Clinical Outcomes in an Internet-Based Cognitive Behavioral Relaxation Program: A Randomized Controlled Trial. J Med Internet Res. 2016 Mar 8;18(3):e52. doi: 10.2196/jmir.5352.