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

Abstract

BackgroundInternet-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 designWe 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.DiscussionBased 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 registrationClinicalTrials.gov Identifier: NCT02499055, registered on 1 July 2015.

Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial

“…One example is the study by Kok, van Straten, Beekman and Cuijpers [36] who examined the efficacy of an Internet-based exposure intervention with weekly support for outpatients waiting for face-to-face psychotherapy for several phobias. In addition, several studies have tested the FearFighter™ program [37] for the treatment of panic and phobia disorders [38–40], which is used in the mental health services in England [41]. Finally, from a transdiagnostic perspective, Schöder, Jelinek and Moritz [42] conducted a randomized controlled trial of an Internet intervention for individuals with panic and phobias.…”

The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial

“…Due to a shortage of similar studies, it is not currently possible to conduct a calculation of optimal sample size for this study. Based on existing knowledge about feasibility study methodology [6,52,54] and two feasibility studies of mHealth tool in public health settings [9,26], we plan to recruit 70 patients. With 70 patients, the 95% confidence interval for a proportion estimate such as compliance would range between 0.38 and 0.62 (if the observed proportion is 0.50), which we consider acceptable for planning further studies.…”

La eficacia de un tratamiento computarizado aplicado a través de Internet para la fobia a volar: Un estudio controlado

“…As explained above, to date, studies about the relative benefits of guided vs. unguided support in Internet delivered interventions have reached different conclusions. The literature shows that guidance is a beneficial feature resulting in better adherence and better outcomes [34,[39][40][41]. However, some studies have shown the efficacy of self-guided treatments (without any contact or support from a therapist, consultant or researcher) [43][44][45][46][47]71].…”

“…To date, evidence shows that guidance is a beneficial feature that leads to better adherence and better outcomes in programs administered through the Internet [34,[39][40][41]. Nevertheless, other authors have shown that unguided self-help interventions are useful alternatives with similar outcomes that might work using automated reinforcement [40,42,43].…”

“…One example is the study by Kok, van Straten, Beekman and Cuijpers [37] who examined the efficacy of an Internetbased exposure intervention with weekly support for outpatients waiting for faceto-face psychotherapy for several phobias. In addition, several studies have tested the FearFighter TM program [38] for the treatment of panic and phobia disorders [39][40][41], which is used in the mental health services in England [42].…”