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Cost-utility and cost-effectiveness of blended eHealth treatment for severe anxiety disorders in secondary mental health care

Cost-utility and cost-effectiveness of blended eHealth treatment for severe anxiety disorders in secondary mental health care - Health care efficiency for blended eHealth treatment for anxiety

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44051
Enrollment
156
Registered
2016-09-06
Start date
2015-11-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Nervousness

Interventions

Treatments in both groups are based on CBT and exposure with response prevention (ERP) protocols for face-to-face treatment of anxiety disorders according to the Dutch multidisciplinary treatment gu
exposure to feared situations combined with prevention of avoidance behaviour and challenging accompanying catastrophic expectations, followed by cognitive restructuring). Depending on the type of
including Serotonin reuptake inhibitors (SSRI's) or as a next step serotonergic Tricyclic Antidepressants. The last part of the protocol will provide information on relapse prevention (identifying
Anxiety
Blended cognitive behavioral treatment
Cost-effectiveness
Specialized mental health care

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)