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Neurobiological and clinical effects of fNIRS-controlled rTMS in patients with panic disorder/agoraphobia during cognitive-behavioural therapy.

ABSTRACT: 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.

SUBMITTER: Deppermann S

PROVIDER: S-EPMC5650598 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Neurobiological and clinical effects of fNIRS-controlled rTMS in patients with panic disorder/agoraphobia during cognitive-behavioural therapy.

Deppermann Saskia S Vennewald Nadja N Diemer Julia J Sickinger Stephanie S Haeussinger Florian B FB Dresler Thomas T Notzon Swantje S Laeger Inga I Arolt Volker V Ehlis Ann-Christine AC Fallgatter Andreas J AJ Zwanzger Peter P

NeuroImage. Clinical 20170922

<h4>Background</h4>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 poten ...[more]

PMID: 29085773

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Project description:IntroductionAnxiety disorders have a high lifetime prevalence, early-onset and long duration or chronicity. Exposure therapy is considered one of the most effective elements in cognitive behavioural therapy (CBT) for anxiety, but in vivo exposure can be challenging to access and control, and is sometimes rejected by patients because they consider it too aversive. Virtual reality allows flexible and controlled exposure to challenging situations in an immersive and protected environment.AimThe SoREAL-trial aims to investigate the effect of group cognitive behavioural therapy (CBT-in vivo) versus group CBT with virtual reality exposure (CBT-in virtuo) for patients diagnosed with social anxiety disorder and/or agoraphobia, in mixed groups.Methods and analysisThe design is an investigator-initiated randomised, assessor-blinded, parallel-group and superiority-designed clinical trial. Three hundred two patients diagnosed with social anxiety disorder and/or agoraphobia will be included from the regional mental health centres of Copenhagen and North Sealand and the Northern Region of Denmark. All patients will be offered a manual-based 14-week cognitive behavioural group treatment programme, including eight sessions with exposure therapy. Therapy groups will be centrally randomised with concealed allocation sequence to either CBT-in virtuo or CBT-in vivo. Patients will be assessed at baseline, post-treatment and 1-year follow-up by treatment blinded researchers and research assistants. The primary outcome will be diagnosis-specific symptoms measured with the Liebowitz Social Anxiety Scale for patients with social anxiety disorder and the Mobility Inventory for Agoraphobia for patients with agoraphobia. Secondary outcome measures will include depression symptoms, social functioning and patient satisfaction. Exploratory outcomes will be substance and alcohol use, working alliance and quality of life.Ethics and disseminationThe trial has been approved by the research ethics committee in the Capital Region of Denmark. All results, positive, negative as well as inconclusive, will be published as quickly as possible and still in concordance with Danish law on the protection of confidentially and personal information. Results will be presented at national and international scientific conferences. The trial has obtained approval by the Regional Ethics Committee of Zealand (H-6-2013-015) and the Danish Data Protection Agency (RHP-2014-009-02670). The trial is registered at ClinicalTrial.gov as NCT03845101. The patients will receive information on the trial both verbally and in written form. Written informed consent will be obtained from each patient before inclusion in the trial. The consent form will be scanned and stored in the database system and the physical copy will be destroyed. It is emphasised that participation in the trial is voluntary and that the patient can withdraw his or her consent at any time without consequences for further and continued treatment.Trial registration numberNCT03845101.

Project description:BackgroundVirtual reality (VR) is as effective a technique as traditional cognitive behavioral therapy (CBT) and a promising tool for treating panic disorder symptoms because VR exposure can be safer and has better acceptability than in vivo exposure and is more immersive than exposure through imagination. CBT techniques can be delivered more effectively using VR as well. So far, VR has required high-quality devices, but the development of mobile VR technology has improved user availability. At the same time, a well-structured form of VR can be reproduced and used anywhere. This means that VR can be used to provide a self-guided form of treatment and address the high treatment costs of evidence-based therapy and the lack of professional therapists. This study aimed to investigate the potential of self-guided VR as an alternative to high-cost treatment.ObjectiveThe main goal of this study was to offer data about the efficacy of a mobile app-based self-led VR CBT in the treatment of panic disorder.MethodsA total of 54 subjects with panic disorder were enrolled in this study and randomly assigned to either the VR treatment group or waitlist group. The VR treatment was designed to be total 12 sessions for 4 weeks. The VR treatment consists of 4 steps in which patients are gradually exposed to phobic stimuli while learning to cope with panic symptoms in each stage. The effectiveness of treatment was assessed through the Panic Disorder Severity Scale, Hamilton Rating Scale for Depression, Body Sensations Questionnaire, Albany Panic and Phobia Questionnaire, Anxiety Sensitivity Index, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale, Korean Inventory of Social Avoidance and Distress Scale, Korean Inventory of Depressive Symptomatology, and Perceived Stress Scale. In addition, physiological changes using heart rate variability were evaluated.ResultsIn within-group analyses, the VR treatment group exhibited improvements in panic disorder symptoms, anxiety, and depression after 4 weeks, while the waitlist group did not show any significant improvement. Compared to the waitlist group, the VR treatment group showed significantly greater improvements in the Panic Disorder Severity Scale in both completer analysis and intention-to-treat analysis. Heart rate variability in the VR treatment group showed improvement in normalized high frequency from baseline to postassessment with no significant differences in any outcome measure between groups.ConclusionsThe self-guided, mobile app-based VR intervention was effective in the treatment of panic symptoms and restoring the autonomic nervous system demonstrating the validity of the use of VR for self-guided treatment. VR treatment can be a cost-effective therapeutic approach.Trial registrationClinicalTrials.gov NCT04985019; https://clinicaltrials.gov/ct2/show/NCT04985019.

Project description:BackgroundDespite the large body of literature demonstrating the effectiveness of cognitive behavioral treatments for agoraphobia, many patients remain untreated because of various barriers to treatment. Web-based and mobile-based interventions targeting agoraphobia may provide a solution to this problem, but there is a lack of research investigating the efficacy of such interventions.ObjectiveThe objective of our study was to evaluate for the first time the effectiveness of a self-guided mobile-based intervention primarily targeting agoraphobic symptoms, with respect to a generic mobile app targeting anxiety.MethodsA Web-based randomized controlled trial (RCT) compared a novel mobile app designed to target agoraphobia (called Agoraphobia Free) with a mobile app designed to help with symptoms of anxiety in general (called Stress Free). Both interventions were based on established cognitive behavioral principles. We recruited participants (N=170) who self-identified as having agoraphobia and assessed them online at baseline, midpoint, and end point (posttreatment) over a period of 12 weeks. The primary outcome was symptom severity measured by the Panic and Agoraphobia Scale.ResultsBoth groups had statistically significant improvements in symptom severity over time (difference -5.97, 95% CI -8.49 to -3.44, P<.001 for Agoraphobia Free and -6.35, 95% CI -8.82 to -3.87, P<.001 for Stress Free), but there were no significant between-group differences on the primary outcome (difference 0.38, 95% CI -1.96 to 3.20, P=.64).ConclusionsThis is, to our knowledge, the first RCT to provide evidence that people who identify as having agoraphobia may equally benefit from a diagnosis-specific and a transdiagnostic mobile-based intervention. We also discuss clinical and research implications for the development and dissemination of mobile mental health apps.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 98453199; http://www.isrctn.com /ISRCTN98453199 (Archived by WebCite at http://www.webcitation.org/6uR5vsdZw).

Dataset Information

Neurobiological and clinical effects of fNIRS-controlled rTMS in patients with panic disorder/agoraphobia during cognitive-behavioural therapy.

Publications

Neurobiological and clinical effects of fNIRS-controlled rTMS in patients with panic disorder/agoraphobia during cognitive-behavioural therapy.

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