Clinical trial NCT02499055: A Randomised Feasibility Trial With Internet Based Self-help Therapy
Official title: Internet Based Self-help Therapy With FearFighter™ Versus no Intervention for Anxiety Disorders in Adult Persons: a Randomised Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: anxiety
behaviour therapy
computer assisted therapy
psychotherapy
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: TrygFonden, Denmark
name: Student Counselling Service, Denmark
First posted: 2015-07-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Fractions of participants that are eligible and can be randomised
timeFrame: up to week 10
measure: Fraction of participants randomised to the experimental group that will comply with the experimental intervention
timeFrame: up to week 10
measure: 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.)
timeFrame: up to 37 weeks after start of intervention
Secondary outcomes:
measure: Symptoms: Beck Anxiety Inventory (BAI)
timeFrame: Baseline, 10 weeks and 37 weeks after start of intervention
measure: Symptoms: Symptom check list-90R (SCL-90R)
timeFrame: Baseline, 10 weeks and 37 weeks after start of intervention
measure: Functionality: Sheehan Disability Scale (SDS)
timeFrame: Baseline, 10 weeks and 37 weeks after start of intervention
measure: Quality of life: WHO Well-Being Index
timeFrame: Baseline, 10 weeks and 37 weeks after start of intervention
measure: Serious adverse events (SAE)
timeFrame: SAE will be registrered throughout the intervention from week 0 to week 10
Other outcomes:
measure: Behaviour log from FearFighter
timeFrame: Behaviour log will be registrered throughout the intervention from week 0 to week 10
Locations:
city: Gentofte
country: Denmark
facility: Psychotherapy Center Stolpegård, Mental Health Services in the Capital Region of Denmark
state: Capital Region
Study officials:
affiliation: Stolpegaard Psychotherapy Centre. Mental Health Services in the Capital Region of Denmark.
name: Marianne Lau, MD
role: STUDY_DIRECTOR
References:
citation: Fenger M, Lindschou J, Gluud C, Winkel P, Jorgensen L, Dybkjaer JH, Lau M. Internet-based therapy with FearFighter for anxiety disorders: a randomised clinical trial. Nord J Psychiatry. 2020 Oct;74(7):518-524. doi: 10.1080/08039488.2020.1755363. Epub 2020 May 13.
citation: Fenger M, Lindschou J, Gluud C, Winkel P, Jorgensen L, Kruse-Blinkenberg S, Lau M. Internet-based self-help therapy with FearFighter versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial. Trials. 2016 Oct 28;17(1):525. doi: 10.1186/s13063-016-1619-3.