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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial

Authors: Morten Fenger, Jane Lindschou, Christian Gluud, Per Winkel, Lise Jørgensen, Sten Kruse-Blinkenberg, Marianne Lau

Published in: Trials | Issue 1/2016

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Abstract

Background

Internet-based self-help psychotherapy (IBT) could be an important alternative or supplement to ordinary face-to-face therapy. The findings of randomised controlled trials indicate that the effects of various IBT programmes for anxiety disorders seem better than no intervention and in some instances are equivalent to usual therapy. In Denmark, IBT is part of future treatment plans in mental health care services, but the verification level of the current clinical scientific knowledge is insufficient. The objective of this trial is feasibility assessment of benefits and harms of the Internet-based cognitive behavioural therapy (ICBT) programme FearFighter™ versus no intervention for anxiety disorders in adults.

Methods and design

We will conduct an investigator-initiated, feasibility randomised controlled trial. Sixty-four participants are expected to be recruited via an advertisement posted on the homepage of the Student Counselling Service in Denmark. The inclusion criterion for participation in the trial will be the presence of anxiety disorder as assessed with the Mini International Neuropsychiatric Interview. The exclusion criteria will be suicidal risk, an ongoing episode of bipolar disorder or psychosis, concurrent psychological treatment for the anxiety disorder, considered unable to attend the intervention as planned (due to vacation, work/study placement, sickness, or similar occurrences), or lack of informed consent. The intervention group will be offered nine sessions with the ICBT programme FearFighter™ and a weekly telephone contact to support compliance. The control group will receive no intervention. We define the feasibility outcomes as follows: the fraction of randomised participants out of the eligible people (the lower 95 % confidence interval (CI) ≥ 50 %); and the fraction of compliant participants (those receiving at least six out of nine sessions) in the intervention group (the lower 95 % CI ≥ 60 %). The exploratory clinical outcomes are the number of participants no longer meeting the diagnostic criteria for an anxiety disorder at the end of the trial and level of distress (Beck Anxiety Inventory, Symptom Checklist-90-R, WHO Well-Being Index, Sheehan Disability Scale); the number of severe adverse events; and the occurrence of any psychological treatment outside the trial.
To prevent bias in design, and in the gathering and analysis of data throughout the trial, we will follow the SPIRIT 2013 statement which defines standard protocol items for clinical trials.

Discussion

Based on our findings, we will discuss the feasibility of a future randomised controlled trial examining the benefits and harms of FearFighter™ versus no intervention for anxiety disorders in adults.

Trial registration

ClinicalTrials.gov Identifier: NCT02499055, registered on 1 July 2015.
Appendix
Available only for authorised users
Footnotes
1
An index of effect equivalent to Cohen’s d.
 
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Metadata
Title
Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial
Authors
Morten Fenger
Jane Lindschou
Christian Gluud
Per Winkel
Lise Jørgensen
Sten Kruse-Blinkenberg
Marianne Lau
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1619-3

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