A Randomised Feasibility Trial With Internet Based Self-help Therapy

Anxiety Clinical Trial

— IBT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02499055
• Other study ID #: FearFighter-RHP2015
• Status: Active, not recruiting
• Phase: N/A
• First received: July 1, 2015
• Last updated: October 11, 2016
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• FearFighter
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.

Locations

Country	Name	City	State
Denmark	Psychotherapy Center Stolpegård, Mental Health Services in the Capital Region of Denmark	Gentofte	Capital Region

Sponsors (4)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research, Student Counselling Service, Denmark, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Behaviour log from FearFighter	Registration of the number of times the participant log on FearFighter.	Behaviour log will be registrered throughout the intervention from week 0 to week 10	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes