Overview

This trial is active, not recruiting.

Condition anxiety
Treatment fearfighter
Sponsor Mental Health Services in the Capital Region, Denmark
Collaborator Copenhagen Trial Unit, Center for Clinical Intervention Research
Start date August 2015
End date December 2016
Trial size 64 participants
Trial identifier NCT02499055, FearFighter-RHP2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The experimental group will use the program FearFighter™.
fearfighter Internet based therapy
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.
(No Intervention)
The control group receive no intervention for nine weeks.

Primary Outcomes

Measure
Fractions of participants that are eligible and can be randomised
time frame: up to week 10
Fraction of participants randomised to the experimental group that will comply with the experimental intervention
time frame: 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.)
time frame: up to 37 weeks after start of intervention

Secondary Outcomes

Measure
Symptoms: Beck Anxiety Inventory (BAI)
time frame: Baseline, 10 weeks and 37 weeks after start of intervention
Symptoms: Symptom check list-90R (SCL-90R)
time frame: Baseline, 10 weeks and 37 weeks after start of intervention
Functionality: Sheehan Disability Scale (SDS)
time frame: Baseline, 10 weeks and 37 weeks after start of intervention
Quality of life: WHO Well-Being Index
time frame: Baseline, 10 weeks and 37 weeks after start of intervention
Serious adverse events (SAE)
time frame: SAE will be registrered throughout the intervention from week 0 to week 10

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Internet Based Self-help Therapy With FearFighter™ Versus no Intervention for Anxiety Disorders in Adult Persons: a Randomised Feasibility Trial
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Mental Health Services in the Capital Region, Denmark.