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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Publications

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: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: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:Background: Although digital cognitive behavioral therapy (dCBT) is considered effective for anxiety disorders, there is considerable heterogeneity in its efficacy across studies, and its varied treatment content and clinical components may explain such heterogeneity. Objective: This review aimed to identify the efficacy of digital cognitive behavioral therapy for panic disorder and agoraphobia, and examine whether applying relevant clinical components of interoceptive exposure, inhibitory-learning-based exposure, and personalization of treatment enhances its efficacy. Methods: Randomized controlled trials of dCBT for panic disorder and agoraphobia with passive or active controls were identified from OVID Medline, Embase, Cochrane Library, and PsycINFO. The overall effect sizes for dCBT groups (interventions through digital platforms based on the internet, mobile, computers, VR, etc.) were aggregated against passive control (placebo/sham) and active control (traditional CBT) groups. For subgroup analysis, key intervention components such as interoceptive exposure, inhibitory learning, and personalization were assessed dichotomously (0 or 1) along with other study characteristics. The stepwise meta-regression models were applied with traditional and Bayesian statistical testing. The risk of bias and publication bias of included studies were assessed. Results: Among the 31 selected studies, dCBT had an overall effect size of g = 0.70 against passive control and g = -0.05 against active control. In subgroup analysis, interoceptive exposure improved the clinical effects for both controls, and inhibitory learning and personalization increased the clinical effects for passive control along with therapist guide/support and the length of sessions. Many studies were vulnerable to therapist bias and attrition bias. No publication bias was detected. Conclusions: The heterogeneity in clinical effects of dCBT for panic and agoraphobia can be explained by the different intervention factors they include. For effective dCBT, therapists should consider the clinical components relevant to the treatment.

Dataset Information

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

Background

Objective

Design

Participants

Interventions

Main measures

Key results

Conclusion

Trial registration

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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