IBT: A Randomised Feasibility Trial With Internet Based Self-help Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FearFighter The experimental group will use the program FearFighter™. |
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.
Other Names:
|
| No Intervention: Control group The control group receive no intervention for nine weeks. |
Outcome Measures
Primary Outcome Measures
- Fractions of participants that are eligible and can be randomised [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 [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.) [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.
Secondary Outcome Measures
- Symptoms: Beck Anxiety Inventory (BAI) [Baseline, 10 weeks and 37 weeks after start of intervention]
Beck Anxiety Inventory (BAI) is a 21-items general questionnaire for anxiety symptoms during the last 14 days.
- Symptoms: Symptom check list-90R (SCL-90R) [Baseline, 10 weeks and 37 weeks after start of intervention]
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.
- Functionality: Sheehan Disability Scale (SDS) [Baseline, 10 weeks and 37 weeks after start of intervention]
Sheehan Disability Scale (SDS). We assess: Occupational function; Social function; and Family function.
- Quality of life: WHO Well-Being Index [Baseline, 10 weeks and 37 weeks after start of intervention]
WHO Well-Being Index.,We assess the quality of life.
- Serious adverse events (SAE) [SAE will be registrered throughout the intervention from week 0 to week 10]
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.
Other Outcome Measures
- Behaviour log from FearFighter [Behaviour log will be registrered throughout the intervention from week 0 to week 10]
Registration of the number of times the participant log on FearFighter.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or older.
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Specific phobia, panic disorder, agoraphobia or social phobia is the primary diagnosis according to the DSM-IV
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Written informed consent.
Exclusion Criteria:
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Acute suicidal risk.
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Ongoing episode of bipolar disorder or psychosis.
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Receive concurrent psychological treatment for an anxiety disorder
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Considered unable to attend IBT sessions as planned (due to vacation, work/study placement, sickness or similar occurrences).
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Lack of informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Psychotherapy Center Stolpegård, Mental Health Services in the Capital Region of Denmark | Gentofte | Capital Region | Denmark | 2820 |
Sponsors and Collaborators
- Mental Health Services in the Capital Region, Denmark
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- TrygFonden, Denmark
- Student Counselling Service, Denmark
Investigators
- Study Director: Marianne Lau, MD, Stolpegaard Psychotherapy Centre. Mental Health Services in the Capital Region of Denmark.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FearFighter-RHP2015