Dataset Information

Cost-effectiveness of Practice Team-Supported Exposure Training for Panic Disorder and Agoraphobia in Primary Care: a Cluster-Randomized Trial.

ABSTRACT: BACKGROUND:Primary care is the main treatment setting for panic disorder and should be supplemented by collaborative care programs. However, shortage of mental health professionals prevents collaborative care programs from being effectively implemented. The PARADISE study showed the efficacy of a self-managed, cognitive-behavioural therapy (CBT)-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the family practice team. OBJECTIVE:To assess the cost-effectiveness of the PARADISE intervention. DESIGN:Cost-effectiveness analysis from the societal perspective based on data from a cluster-randomized controlled trial over a time horizon of 12 months. PARTICIPANTS:Four hundred nineteen adult panic disorder patients with or without agoraphobia. INTERVENTIONS:A self-managed, CBT-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the primary care practice team in comparison to routine care. MAIN MEASURES:Total costs from the societal perspective. Direct costs and disease-specific costs. Quality-adjusted life years based on the EQ-5D-3L. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. KEY RESULTS:Patients in the intervention group caused lower costs (mean, €1017; 95% confidence interval [-€3306; €1272]; p?=?0.38) and gained on average more QALY (mean, 0.034 QALY (95% confidence interval [0.005; 0.062]; p?=?0.02). Therefore, the intervention dominated the control treatment. The probability of cost-effectiveness of the intervention at a willingness-to-pay margin of €50,000 per QALY was 96%. Results from supplementary analyses considering direct or disease-specific costs instead of total costs showed comparable results. CONCLUSION:The PARADISE intervention is cost effective. This conclusion is valid for total costs, generic health care (direct) costs, disease-specific health care costs. TRIAL REGISTRATION:German Clinical Trials Register: DRKS00004386 Current Controlled Trials: ISRCTN64669297.

SUBMITTER: Brettschneider C

PROVIDER: S-EPMC7174430 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Cost-effectiveness of Practice Team-Supported Exposure Training for Panic Disorder and Agoraphobia in Primary Care: a Cluster-Randomized Trial.

Brettschneider Christian C Gensichen Jochen J Hiller Thomas S TS Breitbart Jörg J Schumacher Ulrike U Lukaschek Karoline K Teismann Tobias T Margraf Jürgen J König Hans-Helmut HH

Journal of general internal medicine 20200121 4

<h4>Background</h4>Primary care is the main treatment setting for panic disorder and should be supplemented by collaborative care programs. However, shortage of mental health professionals prevents collaborative care programs from being effectively implemented. The PARADISE study showed the efficacy of a self-managed, cognitive-behavioural therapy (CBT)-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the family practice team.<h ...[more]

PMID: 31965532

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Project description:BACKGROUND:A relevant proportion of patients with panic disorder (PD) does not improve even though they receive state of the art treatment for anxiety disorders such as cognitive-behavioural therapy (CBT). At the same time, it is known, that from a neurobiological point of view, PD patients are often characterised by prefrontal hypoactivation. Intermittent Theta Burst Stimulation (iTBS) is a non-invasive type of neurostimulation which can modulate cortical activity and thus has the potential to normalise prefrontal hypoactivity found in PD. We therefore aimed at investigating the effects of iTBS as an innovative add-on to CBT in the treatment for PD. METHODS:In this double-blind, bicentric study, 44 PD patients, randomised to sham or verum stimulation, received 15 sessions of iTBS over the left prefrontal cortex (PFC) in addition to 9 weeks of group CBT. Cortical activity during a cognitive as well as an emotional (Emotional Stroop) paradigm was assessed both at baseline and post-iTBS treatment using functional near-infrared spectroscopy (fNIRS) and compared to healthy controls. RESULTS:In this manuscript we only report the results of the emotional paradigm; for the results of the cognitive paradigm please refer to Deppermann et al. (2014). During the Emotional Stroop test, PD patients showed significantly reduced activation to panic-related compared to neutral stimuli for the left PFC at baseline. Bilateral prefrontal activation for panic-related stimuli significantly increased after verum iTBS only. Clinical ratings significantly improved during CBT and remained stable at follow-up. However, no clinical differences between the verum- and sham-stimulated group were identified, except for a more stable reduction of agoraphobic avoidance during follow-up in the verum iTBS group. LIMITATIONS:Limitations include insufficient blinding, the missing control for possible state-dependent iTBS effects, and the timing of iTBS application during CBT. CONCLUSION:Prefrontal hypoactivity in PD patients was normalised by add-on iTBS. Clinical improvement of anxiety symptoms was not affected by iTBS.

Project description:BackgroundIn the context of the COVID-19 pandemic, legislations are being modified around the world to allow patients to receive mental health services through telehealth. Unfortunately, there are no large clinical trial available to reliably document the efficacy of delivering videoconferencing psychotherapy (VCP) for people with panic disorder and agoraphobia (PDA) and whether basic psychotherapeutic processes are altered.MethodsThis 2-arm intent-to-treat non-inferiority study reports on a clinical trial on VCP and documents how therapeutic working alliance and motivation toward psychotherapy are associated to treatment outcome. We hypothesized that VCP would not be inferior to standard face-to-face (FF) cognitive behavior therapy for PDA. No specific hypothesis was stated to address working alliance and treatment mechanisms. VCP was compared to a gold-standard psychotherapy treatment for PDA, which was delivered either in person or in videoconference, with a strict tolerance criterion of about 2 points on the primary outcome measure. Seventy one adult patients were recruited. Measures of working alliance were collected after the first, fifth, and last session. Motivation toward therapy at pre-treatment and working alliance after the fifth therapy session were used as predictors of treatment outcome and compared with change in dysfunctional beliefs toward bodily sensations.ResultsPanic disorder, agoraphobia, fear of sensations and depressed mood all showed significant improvements and large effect-sizes from pre to post-treatment. Gains were maintained at follow-up. No significant differences were found between VCP and FF, and effect sizes were trivial for three of the four outcome measures. Non-inferiority tests confirmed that VCP was no less effective than FF therapy on the primary outcome measure and two of the three secondary outcome measures. Working alliance was very strong in VCP and did not statistically differ from FF. Working alliance and motivation did not predict treatment outcome, which was significantly predicted by the reduction in dysfunctional beliefs. The strength of the therapeutic bond was correlated with change in dysfunctional beliefs.ConclusionMental health professionals can use VCP to provide services to patients with PDA. Building and maintaining a sound working alliance should not be a source concern. Practical recommendations are formulated.Isrctn trial registration numberISRCTN76456442.

Project description:BackgroundPeople with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately. Thus, there is a need for studies carried out in different settings for specific anxiety populations. A Danish model for collaborative care (the Collabri model) has been developed for people diagnosed with depression or anxiety disorders. The model is evaluated through four trials, of which three will be outlined in this protocol and focus on panic disorder, generalised anxiety disorder and social phobia. The aim is to investigate whether treatment according to the Collabri model has a better effect than usual treatment on symptoms when provided to people with anxiety disorders.MethodsThree cluster-randomised, clinical superiority trials are set up to investigate treatment according to the Collabri model for collaborative care compared to treatment-as-usual for 364 patients diagnosed with panic disorder, generalised anxiety disorder and social phobia, respectively (total n = 1092). Patients are recruited from general practices located in the Capital Region of Denmark. For all trials, the primary outcome is anxiety symptoms (Beck Anxiety Inventory (BAI)) 6 months after baseline. Secondary outcomes include BAI after 15 months, depression symptoms (Beck Depression Inventory) after 6 months, level of psychosocial functioning (Global Assessment of Functioning) and general psychological symptoms (Symptom Checklist-90-R) after 6 and 15 months.DiscussionResults will add to the limited pool of information about collaborative care for patients with anxiety disorders. To our knowledge, these will be the first carried out in a Danish context and the first to report results for generalised anxiety and social phobia separately. If the trials show positive results, they could contribute to the improvement of future treatment of anxiety disorders.Trial registrationClinicalTrials.gov, ID: NCT02678624 . Retrospectively registered 7 February 2016; last updated 15 August 2016.

Dataset Information

Cost-effectiveness of Practice Team-Supported Exposure Training for Panic Disorder and Agoraphobia in Primary Care: a Cluster-Randomized Trial.

Publications

Cost-effectiveness of Practice Team-Supported Exposure Training for Panic Disorder and Agoraphobia in Primary Care: a Cluster-Randomized Trial.

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