Dataset Information

Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial.

ABSTRACT:

Background

Cognitive behavioral therapy is the first-line treatment for patients with panic disorder (PD) and agoraphobia (AG). Yet, many patients remain untreated due to limited treatment resources. Digital self-guided short-term treatment applications may help to overcome this issue. While some therapeutic applications are already supported by health insurance companies, data on their efficacy is limited. The current study investigates the effect of self-guided digital treatment comprising psychoeducation and virtual reality exposure therapy (VRET).

Methods

Thirty patients diagnosed with PD, AG, or panic disorder with agoraphobia (PDA) will be randomly assigned to either the experimental group (EG) or the control group (CG). Participants of both groups will undergo baseline diagnostics in the first two sessions. The subsequent treatment for the EG consists of a self-guided 6-week phase of application-based psychoeducation, one therapy session preparing for the VRET, and 4 weeks of application-based self-guided VRET. To control for the potential effects of the therapy session with the therapist, the CG will receive relaxation and stress-reduction training instead. All patients will then undergo a closing session which terminates with the post-assessment (~ 10 weeks after baseline assessment) and a follow-up assessment 6 weeks following the closing session. Symptom severity (primary outcome) will be assessed at baseline, interim, post-treatment, and follow-up. Additionally, remission status (secondary outcome) will be obtained at follow-up. Both measures will be compared between the groups.

Discussion

The current study aims at providing insights into the efficacy of short-term treatment applications including psychoeducation and self-guided VRET. If successful, this approach might be a feasible and promising way to ease the burden of PD, AG, and PDA on the public health system and contribute to a faster access to treatment.

Trial registration

ISRCTN ISRCTN10661970 . Prospectively registered on 17 January 2022.

SUBMITTER: Planert J

PROVIDER: S-EPMC9123669 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial.

Planert Jari J Machulska Alla A Hildebrand Anne-Sophie AS Roesmann Kati K Otto Esra E Klucken Tim T

Trials 20220521 1

<h4>Background</h4>Cognitive behavioral therapy is the first-line treatment for patients with panic disorder (PD) and agoraphobia (AG). Yet, many patients remain untreated due to limited treatment resources. Digital self-guided short-term treatment applications may help to overcome this issue. While some therapeutic applications are already supported by health insurance companies, data on their efficacy is limited. The current study investigates the effect of self-guided digital treatment compri ...[more]

PMID: 35597959

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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:BackgroundDue to several treatment barriers, many individuals with panic disorder do not receive evidence-based treatment. One promising option to narrow this treatment gap is Internet-based psychotherapy, which has been shown particularly effective in guided formats. Still, there remains room for improvement to make these digital therapies more accessible, cost-efficient, and aligned with best practices for in-person interventions (e.g., exposure). The smartphone app "Invirto - Treatment for Anxiety" offers digitally guided, evidence-based treatment of panic disorders including virtual reality (VR) for exposure therapy. The aim present study is to investigate the efficacy, safety, and acceptance of Invirto in comparison to a care-as-usual (CAU) control group.MethodsWe plan to conduct a randomized controlled trial with two conditions (intervention vs. CAU), three assessment times via online surveys (t0: baseline; t1: 3 months after baseline; t2: follow-up assessment 6 months after baseline), and a total of 128 participants with a clinical diagnosis of panic disorder (symptoms must be experienced ≥ 1 year). Recruitment will take place via email, phone, and the study website. The primary outcome will be the change in anxiety symptoms as measured by Beck's Anxiety Inventory from t0 to t1. Secondary outcomes will be the change in anxiety symptoms (measured by the Panic and Agoraphobia Scale, PAS; Questionnaire on panic-related Anxieties, Cognitions and Avoidance, ACA), depressive symptoms (measured by the Beck-Depression-Inventory, BDI-II), treatment satisfaction (measured by the Client Satisfaction Questionnaire, CSQ-8; Treatment Adherence Perception Questionnaire, TAPQ-adapt; Positive and Negative Effects of Psychotherapy Scale, PANEPS-I), psychological flexibility (measured by the Acceptance and Action Questionnaire-II, AAQ-II), and dissociation during VR exposure (measured by an adapted version of the Peritraumatic Dissociative Experiences Questionnaire, PDEQ-adapt). Participants in the intervention group will receive access to the intervention (Invirto) right after t0, while the CAU group will receive access to Invirto after t1. We expect a larger change in both the primary and secondary outcomes from t0 to t1 in the intervention group in comparison to the CAU group.DiscussionThis study is one of the first to evaluate an Internet-based intervention for people with panic disorder that includes self-application of VR exposure therapy. The findings are expected to extend the body of knowledge about effective Internet-based treatment options for people with panic disorder. The empirical and clinical implications and the limitations of the study are discussed.Trial registrationDRKS00027585 ( www.drks.de/drks_web/ ), date of registration: 13 January 2022.

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.

Project description:BackgroundTransdiagnostic 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.Methods/designThe 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.DiscussionThe 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.Trial registrationClinicaltrials.gov NCT02954731 . Registered 25 October 2016.

Project description:BackgroundAviophobia (the fear of flying) can greatly impact the daily life functioning of people with the condition. Traditional exposure-based treatment is hampered by the limited availability of airplane practice situations, which is a result of economical and practical concerns. Easily accessible and low-cost virtual reality exposure therapy may address these challenges.ObjectiveThe purpose of our study is to investigate the effectiveness of ZeroPhobia: Aviophobia (a self-help mobile app-based treatment) in reducing flight anxiety symptoms and depressive and anxiety symptoms. We will also investigate the effects of usage intensity, the sense of immersion, inherent absorption ability, and perceived user-friendliness on the treatment effect.MethodsParticipants (N=114) who are aged 18-64 years and experience at least mild symptoms of aviophobia will be recruited from the general Dutch population and randomized into a treatment group or waitlist control group. By using their own phones and rudimentary mobile virtual reality headsets, participants will receive six modules of psychoeducation and cognitive behavioral therapy, which will include six levels of virtual reality exposure therapy over a period of 6 weeks. Assessments will be conducted at baseline, posttest (ie, after 6 weeks), and 3- and 12-month follow-ups. The primary outcome measure of our study is the Flight Anxiety Situations Questionnaire. The secondary outcome measures include anxiety and depression measures and additional covariates (including usage intensity, the degree of immersion, etc). We will test treatment effectiveness by conducting an intention-to-treat analysis and estimating average treatment effects on the treated. The mechanisms of treatment effect will also be explored.ResultsThe study was funded on September 25, 2018. Ethical approval was received on October 11, 2019. Recruitment closed on May 7, 2020.ConclusionsOur study will further the scientific understanding and clinical implications of technology's current ability to aid in providing effective, accessible treatment for the fear of flying.Trial registrationNetherlands Trial Registry NL70238.029.19; https://www.trialregister.nl/trial/8257.International registered report identifier (irrid)DERR1-10.2196/22008.

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:ObjectiveTo identify drug classes and individual selective serotonin reuptake inhibitors (SSRIs) with high rates of remission and low risk of adverse events in the treatment of panic disorder with or without agoraphobia.DesignSystematic review and network meta-analysis.Data sourcesEmbase, Medline, and ClinicalTrials.gov from inception to 17 June 2021.Eligibility criteria for study selectionRandomised controlled trials that included adults aged ≥18 years with a diagnosis of panic disorder, compared drugs used to treat the panic disorder, and measured the outcomes of interest, including remissions, dropouts, and adverse events.MethodsRisk of bias in the included studies was assessed using the revised Cochrane risk of bias tool for randomised trials. Direct meta-analyses were performed using random effects models. A two stage network meta-analysis with surface under the cumulative ranking curve (SUCRA) was used to estimate the comparative efficacy of drug classes and individual SSRIs.Results87 studies including a total of 12 800 participants and 12 drug classes were eligible for inclusion. Almost all the studies (86/87) had some concern or were at high risk of bias. Network meta-analysis of remission with consistent results indicated that tricyclic antidepressants, benzodiazepines, monoamine oxidase inhibitors, SSRIs, and serotonin-noradrenaline reuptake inhibitors (SNRIs) were associated with significantly higher remission rates than placebo, with risk ratios of 1.39 (95% confidence interval 1.26 to 1.54), 1.47 (1.36 to 1.60), 1.30 (1.00 to 1.69), 1.38 (1.26 to 1.50), and 1.27 (1.12 to 1.45), respectively. SUCRAs identified benzodiazepines (84.5%, mean rank=2.4), tricyclic antidepressants (68.7%, 3.8), and SSRIs (66.4%, 4.0) as the top three best treatments for remission. However, tricyclic antidepressants, benzodiazepines, and SSRIs were also significantly associated with increased risk of adverse events compared with placebo, with risk ratios of 1.79 (1.47 to 2.19), 1.76 (1.50 to 2.06), and 1.19 (1.01 to 1.41), respectively. Consistency assumption of adverse events was upheld but could still be present on removal of studies with high percentages of women participants and those with agoraphobia. A SUCRA cluster ranking plot considering both remission and adverse events among all drug classes indicated that SSRIs were associated with high remission and low risk of adverse events. Among individual SSRIs, sertraline and escitalopram provided high remission with an acceptable risk of adverse events.ConclusionThe findings suggest that SSRIs provide high rates of remission with low risk of adverse events for the treatment of panic disorder. Among SSRIs, sertraline and escitalopram were associated with high remission and low risk of adverse events. The findings were, however, based on studies of moderate to very low certainty levels of evidence, mostly as a result of within study bias, inconsistency, and imprecision of the findings reported.Systematic review registrationPROSPERO CRD42020180638.

Dataset Information

Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial.

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