Internet Based Self-help Therapy With FearFighter™ Versus no Intervention for Anxiety Disorders in Adult Persons: a Randomised Feasibility Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Fraction of participants randomised to the experimental group that will comply with the experimental intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older.
- •Specific phobia, panic disorder, agoraphobia or social phobia is the primary diagnosis according to the DSM-IV
- •Written informed consent.
排除标准
- •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.
结局指标
主要结局
Fraction of participants randomised to the experimental group that will comply with the experimental intervention
时间窗: 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
Fractions of participants that are eligible and can be randomised
时间窗: 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.
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.)
时间窗: 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.
次要结局
- Symptoms: Symptom check list-90R (SCL-90R)(Baseline, 10 weeks and 37 weeks after start of intervention)
- Quality of life: WHO Well-Being Index(Baseline, 10 weeks and 37 weeks after start of intervention)
- Serious adverse events (SAE)(SAE will be registrered throughout the intervention from week 0 to week 10)
- Symptoms: Beck Anxiety Inventory (BAI)(Baseline, 10 weeks and 37 weeks after start of intervention)
- Functionality: Sheehan Disability Scale (SDS)(Baseline, 10 weeks and 37 weeks after start of intervention)