Therapy Labs: To Improve Adherence in Internet Based Psychotherapy

NCT ID: NCT02535598

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-09-30

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.

Conditions

Behavior Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: SINGLE

Study Groups

Normal presentation

Standard internet based CBT presentation.

Group Type: ACTIVE_COMPARATOR

Normal presentation

Intervention Type: BEHAVIORAL

All the material will be presented as plain text.

Enhanced presentation

Enhanced internet CBT presentation.

Group Type: EXPERIMENTAL

Enhanced presentation

Intervention Type: BEHAVIORAL

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

Normal support

Standard internet based CBT support.

Group Type: ACTIVE_COMPARATOR

Normal support

Intervention Type: BEHAVIORAL

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

Enhanced support

Enhanced internet CBT support.

Group Type: EXPERIMENTAL

Enhanced support

Intervention Type: BEHAVIORAL

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

Interventions

Normal presentation

All the material will be presented as plain text.

Intervention Type: BEHAVIORAL

Enhanced presentation

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

Intervention Type: BEHAVIORAL

Normal support

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

Intervention Type: BEHAVIORAL

Enhanced support

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timo Hursti, PhD

Role: STUDY_DIRECTOR

Uppsala University

Locations

Uppsala University

Uppsala, Uppsala County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 26957354 (View on PubMed)

Other Identifiers

sveal1031

Identifier Type: -

Identifier Source: org_study_id