Anxiety Nervousness
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of a severe anxiety disorder Age>18 years Sufficient command of the Dutch Language Access to the Internet, an e-mail adress and a personal computer (PC) or tablet computer Willing to be randomised to one of the two treatment conditions Signed informed consent form
Exclusion criteria
Exclusion criteria: Primary diagnosis of a bipolar, psychotic or substance abuse disorder and/or acute risk of suicide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The health-economic analyses combine clinical outcomes with cost estimates. Measures of these primary variables are described in this section. Primary clinical outcomes are 1) Severity of anxiety symptoms measured with the Beck Anxiety Inventory (BAI), 2) quality-adjusted life years (QALY*s), derived from the Euro Quality of Life questionnaire (EQ-5D-3L) and health-related quality of life, tapped by the SF-36 Health Survey. * Beck Anxiety Inventory (BAI) (Beck et al., 1988)consists of twenty-one questions about how the subject has been feeling in the last week, expressed as common symptoms of anxiety (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). It is designed for an age range of 17* 80 years old. Each question has the same set of four possible answer choices, which are arranged in columns and are answered by marking the appropriate one with a cross. The BAI has a maximum score of 63. For this study, treatment response is defined as a symptom reduction of the baseline BAI symptom severity score of at least 30% and remission A score reduction of at least 30% reductie plus a totale score | — |
Secondary
| Measure | Time frame |
|---|---|
| To further evaluate bCBT compared to CBTAU, a number of explorative measures are administered. *BDI (Beck Depression Inventory) (Beck et al., 1961) is a 21-question multiple choice self report inventory of the most widely used instruments for measuring the severity of depression and assesses presence and severity of depressive symptoms. *BSI (Brief Symptom Inventory) (Derogatis and Melisaratos, 1983)is a 53-item, self-report symptom inventory designed to evaluate general psychopathology. It is a brief form of the SCL-90 and is designed to provide a multidimensional symptom measurement in about 10 minutes. *PDSS (Panic Disorder Severity Scale (PDSS) (Shear et al., 1997) is one tool that can be used to assess the severity of your panic attacks. The scale is fairly simple. There are only 7 questions numbered, each one with 5 answers that can be worth a maximum of 4 points (using 0 to 4 for scoring). That leads to 28 total points possible with this scale. Any score over 9 is considered important enough to discuss with a clinical psychologist. *LSAS (Liebowitz Social Anxiety Scale) originally developed by Liebowitz (1987) is a short questionnaire to assess the range of social interaction and performance situations feared by a patient in order to assist in the diagnosis of social anxiety disorder. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations and has been validated as a self-report scale (Rytwinski et al., 2009). *PSWQ (Penn State Worry Questionnaire) (Meyer et al., 1990) is a elf-report measure to assess pathological worry in GAD patients. By adding up the value (five-point scale, range 1*5) of all 16 items (e.g., *I*m always worrying about something*) a score from 16 to 80 can be reached. *WSAS (Work and Social Adjustment Scale) (Mundt et al., 2002) (is a simple 5-item patient self-report measure, which assesses the impact of a person*s mental health difficulties on their ability to functi | — |
Countries
The Netherlands