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

Background:

In the Netherlands, treatment of patients with anxiety disorders in secondary mental health care costs €128 million per year.The costs due to absenteeism are €998 million per year.

Treatment as usual (TAU) for anxiety disorders entails cognitive behavioural therapy (CBT). Internet based CBT (iCBT) can increase availability, has proven to be at least equally effective and requires less therapist time. Blended eHealth is a combination treatment, in which regular face-to-face CBT contacts are partially replaced by iCBT and is applied in secondary mental health care.



Objective:

To investigate the efficacy and cost-effectiveness of blended eHealth treatment versus TAU for patients with anxiety disorders in secondary mental health care. We hypothesize that blended eHealth treatment is evenly effective, but more cost-effective than TAU.



Design:

In a multicenter, randomized controlled clinical trial blended eHealth treatment is compared to TAU. Measurements: baseline (T0), 8 weeks (T1: mid-treatment), 16 weeks (T2: post-treatment), 52 weeks after treatment (T3: follow-up).



Population:

Patients over 18 years of age with severe anxiety disorders (DSM-IV: panic disorder with or without agoraphobia, generalized anxiety disorder or social phobia) referred for outpatient treatment in the secondary mental health services.



Interventions:

Blended eHealth is protocolled and contains max. 16 sessions, of which 8 face-to-face CBT and 8 iCBT sessions. TAU includes max. 16 regular face-to-face CBT sessions.



Outcomes:

Primary: Anxiety (BAI). Secondary: quality of life (EQ-5D), Depression (BDI), general psychopathology (BSI) and disease-specific symptoms. Economic: The direct and indirect costs of care and due to absenteeism (TIC-p).



Sample-size:

Inclusion of 78 patients per condition (total n = 156). The sample size in this equivalence study is based on an applied equivalence limit difference ES of 0.4 with a 80% power that both treatments are similar



Analysis:

The differential efficacy is analysed in an intention to treat analysis. The cost-effectiveness and utility analysis is conducted from both a healthcare and social perspective and contains incremental cost-utility and cost-effectiveness ratios. A Markov model will estimate the long-term economic outcome and the budget impact.



Time schedule:

36 months: preparation (3), inclusion (18), follow-up (12) and analysing and reporting (3).

Blended eHealth treatment is evenly effective and more cost-effective than treatment as usual.

T0 = 0 weeks

T1 = 8 weeks after baseline

T2 = 16 weeks after baseline

T3 = 52 weeks after end of treatment

Blended eHealth is a combination treatment, in which regular face-to-face CBT contacts are partially replaced by internet based CBT (iCBT). This blended treatment is applied in secondary mental health care as fewer patients drop out of treatment when there is some face-to-face contact with a therapist, in contrast to primary care. The iCBT modules in blended eHealth resemble conventional CBT modules of weekly sessions (up to 16); both consisting of a
combination of exposure in vivo with response prevention (ERP; exposure to feared situations combined with prevention of avoidance behaviour and challenging accompanying catastrophic expectations), followed by cognitive restructuring. The iCBT sessions include video’s and text boxes where patients receive therapy information and can provide feedback and track
registration of their assignments. Once an exercise is completed, the therapist receives a message or an alert and can provide feedback, if necessary.


The control group will receive care as usual. The usual standard care CBT interventions for anxiety disorders in secondary mental health care entails face-to-face sessions with a therapist and usually consist of a combination of exposure in vivo with response prevention (ERP; exposure to feared
situations combined with prevention of avoidance behaviour and challenging accompanying catastrophic expectations, followed by cognitive restructuring). Depending on the type of disorder all of these components receive more or less attention in the therapy. In case of comorbidity (ie. depression) or when the initial CBT response is insufficient, psychotropic drugs are added,
including Serotonin reuptake inhibitors (SSRI's) or as a next step Tricyclic Antidepressant Clomipramine.