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Videoconferencing Psychotherapy for Panic Disorder and Agoraphobia: Outcome and Treatment Processes From a Non-randomized Non-inferiority Trial.

ABSTRACT: Background:In 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. Methods:This 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. Results:Panic 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. Conclusion:Mental 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 Number:ISRCTN76456442.

SUBMITTER: Bouchard S

PROVIDER: S-EPMC7472915 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Videoconferencing Psychotherapy for Panic Disorder and Agoraphobia: Outcome and Treatment Processes From a Non-randomized Non-inferiority Trial.

Bouchard Stéphane S Allard Micheline M Robillard Geneviève G Dumoulin Stéphanie S Guitard Tanya T Loranger Claudie C Green-Demers Isabelle I Marchand André A Renaud Patrice P Cournoyer Louis-Georges LG Corno Giulia G

Frontiers in psychology 20200821

<h4>Background</h4>In 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.<h4>Methods</h4>This 2-arm intent-to-treat non-inferiority stud ...[more]

PMID: 32973638

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Project description:Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT.The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence.The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect.Clinicaltrials.gov NCT02954731 . Registered 25 October 2016.

Project description:BackgroundPrimary 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.ObjectiveTo assess the cost-effectiveness of the PARADISE intervention.DesignCost-effectiveness analysis from the societal perspective based on data from a cluster-randomized controlled trial over a time horizon of 12 months.ParticipantsFour hundred nineteen adult panic disorder patients with or without agoraphobia.InterventionsA 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 measuresTotal 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 resultsPatients 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.ConclusionThe PARADISE intervention is cost effective. This conclusion is valid for total costs, generic health care (direct) costs, disease-specific health care costs.Trial registrationGerman Clinical Trials Register: DRKS00004386 Current Controlled Trials: ISRCTN64669297.

Project description:BackgroundAn estimated 366 million people are living with diabetes worldwide and it is predicted that its prevalence will increase to 552 million by 2030. Management of this disease and its complications is a challenge for many countries. Optimal glycaemic control is necessary to minimize complications, but less than 70% of diabetic patients achieve target levels of blood glucose, partly due to poor access to qualified health care providers. Telemedicine has the potential to improve access to health care, especially for rural and remote residents. Video teleconsultation, a real-time (or synchronous) mode of telemedicine, is gaining more popularity around the world through recent improvements in digital telecommunications. If video consultation is to be offered as an alternative to face-to-face consultation in diabetes assessment and management, then it is important to demonstrate that this can be achieved without loss of clinical fidelity. This paper describes the protocol of a randomised controlled trail for assessing the reliability of remote video consultation for people with diabetes.Methods/designA total of 160 people with diabetes will be randomised into either a Telemedicine or a Reference group. Participants in the Reference group will receive two sequential face-to-face consultations whereas in the Telemedicine group one consultation will be conducted face-to-face and the other via videoconference. The primary outcome measure will be a change in the patient's medication. Secondary outcome measures will be findings in physical examination, detecting complications, and patient satisfaction. A difference of less than 20% in the aggregated level of agreement between the two study groups will be used to identify if videoconference is non-inferior to traditional mode of clinical care (face-to-face).DiscussionDespite rapid growth in application of telemedicine in a variety of medical specialties, little is known about the reliability of videoconferencing for remote consultation of people with diabetes. Results of this proposed study will provide evidence of the reliability of specialist consultation offered by videoconference for people with diabetes.Trial registration numberAustralian New Zealand Clinical Trials Registry ACTRN12612000315819.

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.

Dataset Information

Videoconferencing Psychotherapy for Panic Disorder and Agoraphobia: Outcome and Treatment Processes From a Non-randomized Non-inferiority Trial.

Publications

Videoconferencing Psychotherapy for Panic Disorder and Agoraphobia: Outcome and Treatment Processes From a Non-randomized Non-inferiority Trial.

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