AnxietyIBTNCT02499055
A Randomised Feasibility Trial With Internet Based Self-help Therapy
A study testing FearFighter in people with Anxiety, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- FearFighter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Specific phobia, panic disorder, agoraphobia or social phobia is the primary diagnosis according to the DSM-IV
- Written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychotherapy Center Stolpegård, Mental Health Services in the Capital Region of Denmark
Gentofte Municipality, Capital Region, 2820
About this study
Official title: Internet Based Self-help Therapy With FearFighter™ Versus no Intervention for Anxiety Disorders in Adult Persons: a Randomised Feasibility Trial
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.
Read more
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.
- Conditions
- Anxiety
- Being tested
- FearFighter
- Keywords
- anxiety, behaviour therapy, computer assisted therapy, psychotherapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FearFighterBehavioural
Also called Internet based therapy, Computer assisted 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.
| Study group | Role | What they receive |
|---|---|---|
| FearFighter | Experimental | The experimental group will use the program FearFighter™. Receives: Behavioral: FearFighter |
| Control group | No intervention | The control group receive no intervention for nine weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: up to 37 weeks after start of intervention
Secondary outcomes (5)
Symptoms: Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI) is a 21-items general questionnaire for anxiety symptoms during the last 14 days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: SAE will be registrered throughout the intervention from week 0 to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, TrygFonden, Denmark, Student Counselling Service, Denmark
- Responsible party
- Sponsor
- Investigators
- Marianne Lau, MD, Study director, Stolpegaard Psychotherapy Centre. Mental Health Services in the Capital Region of Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499055
- Sponsor's protocol ID
- FearFighter-RHP2015
- Acronym
- IBT
- Status last verified
- Oct 2016
- First submitted
- 1 Jul 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32401099Fenger 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.
PubMed 27793181
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Based Self-help Therapy With FearFighter™ Versus no Intervention for Anxiety Disorders in Adult Persons: a Randomised Feasibility Trial
- ClinicalTrials.gov ID
- NCT02499055
- Acronym / sponsor ID
- IBT / FearFighter-RHP2015
- Conditions
- Anxiety
- Keywords
- anxiety, behaviour therapy, computer assisted therapy, psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, TrygFonden, Denmark, Student Counselling Service, Denmark
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FearFighter | Experimental | Behavioral: FearFighterThe experimental group will use the program FearFighter™. |
| Control group | No intervention | –The control group receive no intervention for nine weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older.
- Specific phobia, panic disorder, agoraphobia or social phobia is the primary diagnosis according to the DSM-IV
- Written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FearFighterAlso: Internet based therapy, Computer assisted therapyFearFighter™ 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. | Behavioural | FearFighter |
Primary outcome
Fractions of participants that are eligible and can be randomised
Time frame: up to week 10
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.
Fraction of participants randomised to the experimental group that will comply with the experimental intervention
Time frame: up to week 10
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
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
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Derived from this study: PubMed 32401099Fenger 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.
- Derived from this study: PubMed 27793181Fenger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Lau, MD study director
Stolpegaard Psychotherapy Centre. Mental Health Services in the Capital Region of Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FearFighter in people with Anxiety, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractions of participants that are eligible and can be randomised (time frame: up to week 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02499055, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.