A Randomised Feasibility Trial With Internet Based Self-help Therapy

Study Overview
=================
Brief Summary
-----------------
Background. In Denmark, about 350,000 persons suffer from anxiety. Public health-care services plan to implement internet based self-help psychotherapy (IBT) to be an important alternative and supplement to ordinary face-to-face therapy. Meta-analyses indicate that the effect of IBT for anxiety disorders seems better than no intervention, and in some instances equal to 'usual therapy'. But studies have been characterised by small sample sizes, high risk for bias, including high dropout. Objective. The objective of this pilot trial is to assess the feasibility of conducting a larger confirmatory trial investigating the benefits and harms of an internet-based self-help therapy program, FearFighter™, compared with no intervention for persons with an anxiety disorder. Design. An investigator-initiated feasibility randomised clinical trial investigating internet-based therapy with FearFighter™ compared with no intervention for persons with an anxiety disorder. We will include 64 participants. Eligibility criteria. Inclusion criteria: age 18 or older; specific phobia, panic disorder, agoraphobia, or social phobia is the primary diagnosis according to the DSM-IV; and informed consent. Exclusion criteria: suicidal risk; ongoing episode of bipolar disorder or psychosis; concurrent psychological treatment for the anxiety disorder; unable to attend the intervention; or lack of informed consent. Intervention. The intervention group will use the program FearFighter™, a nine session cognitive behavioural self-help therapy program delivered over the internet during nine weeks. The control group receive no intervention for nine weeks. Outcomes. Feasibility outcomes are the fraction that are eligible, the fraction that are randomised, and the compliance in the intervention group. Clinical exploratory outcomes are: remission, Beck Anxiety Inventory, Symptom Check List-90R, WHO Well-Being Index, Sheehan Disability Scale, serious adverse events, and behaviour log from FearFighter. Time schedule. Participants will be included in the trial from July 2015. Results are expected in February 2016.

Official Title
-----------------
Internet Based Self-help Therapy With FearFighter™ Versus no Intervention for Anxiety Disorders in Adult Persons: a Randomised Feasibility Trial

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: FearFighter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older. Specific phobia, panic disorder, agoraphobia or social phobia is the primary diagnosis according to the DSM-IV Written informed consent. Exclusion Criteria: Acute suicidal risk. Ongoing episode of bipolar disorder or psychosis. Receive concurrent psychological treatment for an anxiety disorder Considered unable to attend IBT sessions as planned (due to vacation, work/study placement, sickness or similar occurrences). Lack of informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FearFighter<br>The experimental group will use the program FearFighter™. | Behavioral: FearFighter<br>* FearFighter™ is a nine session cognitive behavioural self-help therapy program delivered over the internet during nine weeks. Each session on FearFighter excluding the homework takes about 30-40 minutes to finish. A support person will make a weekly contact of 10 minutes in average to secure understanding of the program and compliance.<br>* Other names: Computer assisted therapy;|
| No Intervention: Control group<br>The control group receive no intervention for nine weeks. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractions of participants that are eligible and can be randomised | We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomised persons. Here, we consider eligible participants' to be persons who fulfill the inclusion criteria. Exclusion criteria and informed consent is not included in this definition of eligibility. | up to week 10 | 
| Fraction of participants randomised to the experimental group that will comply with the experimental intervention | We will determine the fraction of participants randomised to the experimental group that will comply with the experimental intervention, defined as completing at least 6 of 9 FearFighter™ sessions during the intervention | up to week 10 | 
| Proportion of participants who fulfil the diagnostic criteria for an anxiety disorder at the end of the intervention measured with 'Mini International Neuropsychiatric Interview' (M.I.N.I.) | Participants are diagnostic assessed with the 'Mini International Neuropsychiatric Interview' (M.I.N.I.), a short structured interview for the most important psychiatric axis 1 diagnoses in DSM-IV and in ICD-10. | up to 37 weeks after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms: Beck Anxiety Inventory (BAI) | Beck Anxiety Inventory (BAI) is a 21-items general questionnaire for anxiety symptoms during the last 14 days. | Baseline, 10 weeks and 37 weeks after start of intervention | 
| Symptoms: Symptom check list-90R (SCL-90R) | Symptom check list-90R (SCL-90R) is a 90-item questionnaire measuring psychological distress and psychopathology (35). Within SCL-90R we use: Global severity index (GSI); Interpersonal sensitivity subscale; Anxiety subscale; and Phobic anxiety subscale. | Baseline, 10 weeks and 37 weeks after start of intervention | 
| Functionality: Sheehan Disability Scale (SDS) | Sheehan Disability Scale (SDS). We assess: Occupational function; Social function; and Family function. | Baseline, 10 weeks and 37 weeks after start of intervention | 
| Quality of life: WHO Well-Being Index | WHO Well-Being Index.,We assess the quality of life. | Baseline, 10 weeks and 37 weeks after start of intervention | 
| Serious adverse events (SAE) | Serious adverse events, defined as any adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Other adverse events, defined as any undesirable medical event occurring to a participant during a clinical trial, which does not necessarily have a causal relationship with the intervention. | SAE will be registrered throughout the intervention from week 0 to week 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, behaviour therapy, computer assisted therapy, psychotherapy