title: Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov Identifier: NCT02499055 , registered on 1 July 2015.
authors: Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Stolpegaardsvej 20, 2820, Gentofte, Denmark. morten.fenger@regionh.dk.
authors: Morten
authors: 0000-0001-9176-4804
authors: M
authors: Fenger
authors: The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, 2100, Copenhagen, Denmark.
authors: Jane
authors: J
authors: Lindschou
authors: The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, 2100, Copenhagen, Denmark.
authors: Christian
authors: C
authors: Gluud
authors: The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, 2100, Copenhagen, Denmark.
authors: Per
authors: P
authors: Winkel
authors: Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Stolpegaardsvej 20, 2820, Gentofte, Denmark.
authors: Lise
authors: L
authors: Jørgensen
authors: Student Counselling Service, Dronningens Tværgade 30, 2, 1302, Copenhagen, Denmark.
authors: Sten
authors: S
authors: Kruse-Blinkenberg
authors: Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Stolpegaardsvej 20, 2820, Gentofte, Denmark.
authors: Marianne
authors: M
authors: Lau
mesh_terms: D001008:Anxiety Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D057189:Checklist; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003718:Denmark; D004185:Disability Evaluation; D005239:Fear; D005240:Feasibility Studies; D006801:Humans; D020407:Internet; D007407:Interviews as Topic; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012648:Self Care / Q000009:adverse effects / Q000379:methods*; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Anxiety; Cognitive behavioural therapy; FearFighter™; Internet-based psychotherapy; Randomised feasibility trial