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An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial.

ABSTRACT: Flying phobia (FP) is a common and disabling mental disorder. Although in vivo exposure is the treatment of choice, it is linked to a number of limitations in its implementation. Particularly important, is the limited access to the feared stimulus (i.e., plane). Moreover, the economic cost of in vivo exposure should be specially considered as well as the difficulty of applying the exposure technique in an appropriate way; controlling important variables such as the duration of the exposure or the number of sessions. ICTs could help to reduce these limitations. Computer-assisted treatments have remarkable advantages in treating FP. Furthermore, they can be delivered through the Internet, increasing their advantages and reaching more people in need. The Internet has been established as an effective way to treat a wide range of mental disorders. However, as far as we know, no controlled studies exist on FP treatment via the Internet. This study aims to evaluate the efficacy of an Internet-based treatment for FP (NO-FEAR Airlines) versus a waiting list control group. Secondary objectives will be to explore two ways of delivering NO-FEAR Airlines, with or without therapist guidance, and study the patients' acceptance of the program. This paper presents the study protocol.The study is a randomized controlled trial. A minimum of 57 participants will be randomly assigned to three conditions: a) NO-FEAR Airlines totally self-applied, b) NO-FEAR Airlines with therapist guidance, or c) a waiting list control group (6 weeks). Primary outcomes measures will be the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes will be included to assess other relevant clinical measures, such as the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Analyses of post-treatment flights will be conducted. Treatment acceptance and preference measures will also be included. Intention-to-treat and per protocol analyses will be conducted.An Internet-based treatment for FP could have considerable advantages in managing in vivo exposure limitations, specifically in terms of access to treatment, acceptance, adherence, and the cost-effectiveness of the intervention. This is the first randomized controlled trial to study this issue.Clinicaltrials.gov: NCT02298478 . Trial registration date 3 November 2014.

SUBMITTER: Campos D

PROVIDER: S-EPMC4992303 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial.

Campos Daniel D Bretón-López Juana J Botella Cristina C Mira Adriana A Castilla Diana D Baños Rosa R Tortella-Feliu Miquel M Quero Soledad S

BMC psychiatry 20160820

<h4>Background</h4>Flying phobia (FP) is a common and disabling mental disorder. Although in vivo exposure is the treatment of choice, it is linked to a number of limitations in its implementation. Particularly important, is the limited access to the feared stimulus (i.e., plane). Moreover, the economic cost of in vivo exposure should be specially considered as well as the difficulty of applying the exposure technique in an appropriate way; controlling important variables such as the duration of ...[more]

PMID: 27544428

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Project description:BACKGROUND:Internet-based treatments appear to be a promising way to enhance the in vivo exposure approach, specifically in terms of acceptability and access to treatment. However, the literature on specific phobias is scarce, and, as far as we know, there are no studies on Flying Phobia (FP). This study aims to investigate the effectiveness of an Internet-based exposure treatment for FP (NO-FEAR Airlines) that includes exposure scenarios composed of images and sounds, versus a waiting-list control group. A secondary aim is to explore two ways of delivering NO-FEAR Airlines, with and without therapist guidance. METHODS:A randomized controlled trial (RCT) was conducted in which 69 participants were allocated to: 1) NO-FEAR Airlines totally self-applied, 2) NO-FEAR Airlines with therapist guidance, 3) a waiting-list control group. Primary outcome measures were the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes included the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Behavioral outcomes (post-treatment flights and safety behaviors) were also included. Mixed-model analyses with no ad hoc imputations were conducted for primary and secondary outcome measures. RESULTS:NO-FEAR Airlines (with and without therapist guidance) was significantly effective, compared to the waiting list control group, on all primary and secondary outcomes (all ps < .05), and no significant differences were found between the two ways of delivering the intervention. Significant improvements on diagnostic status and reliable change indexes were also found in both treatment groups at post-treatment. Regarding behavioral outcomes, significant differences in safety behaviors were found at post-treatment, compared to the waiting list. Treatment gains were maintained at 3- and 12-month follow-ups. CONCLUSION:FP can be treated effectively via the Internet. NO-FEAR Airlines helps to enhance the exposure technique and provide access to evidence-based psychological treatment to more people in need. These data are congruent with previous studies highlighting the usefulness of computer-assisted exposure programs for FP, and they contribute to the literature on Internet-based interventions. To the best of our knowledge, this is the first RCT to investigate the effectiveness of an Internet-based treatment for FP and explore two ways of delivering the intervention (with and without therapist guidance). TRIAL REGISTRATION:Clinicaltrials.gov: NCT02298478 ( https://clinicaltrials.gov/ct2/show/NCT02298478 ). Trial registration date 3 November 2014.

Project description:BackgroundFlying Phobia (FP) is a prevalent disorder that can cause serious interference in a person's life. ICBT interventions have already shown their efficacy in several studies, but studies in the field of specific phobias are still scarce. Moreover, few studies have investigated the feasibility of using different types of images in exposure scenarios in ICBTs and no studies have been carried out on the role of sense of presence and reality judgement. The aim of the present study is to explore the feasibility of an ICBT for FP (NO-FEAR Airlines) using two types of images with different levels of immersion (still and navigable images). A secondary aim is to explore the potential effectiveness of the two experimental conditions using two types of images compared to a waiting list control group. Finally, the role of navigable images compared to the still images in the level of anxiety, sense of presence, and reality judgement will also be explored. This paper presents the study protocol.MethodsThis study is a three-armed feasibility pilot study with the following conditions: NO-FEAR Airlines with navigable images, NO-FEAR Airlines with still images, and a waiting list group. A minimum of 60 participants will be recruited. The intervention will have a maximum duration of 6 weeks. Measurements will be taken at four different moments: baseline, post-intervention, and two follow-ups (3- and 12-month). Participants' opinions, preference, satisfaction and acceptance regarding the images used in the exposure scenarios will be assessed. FP symptomatology outcomes will also be considered for secondary analyses. The anxiety, sense of presence, and reality judgement in the exposure scenarios will also be analysed.DiscussionThis study will conduct a pilot study on the feasibility of an ICBT for FP and it is the first one to explore the evaluation of patients of the two type of images (still and navigable) and the role of presence and reality judgement in exposure scenarios delivered through the Internet. Research in this field can have an impact on the way these scenarios are designed and developed, as well as helping to explore whether they have any effect on adherence.Trial registrationNCT03900559. Trial Registration date 3 April 2019, retrospectively registered.

Project description:BackgroundMore research is needed in the field of Internet-delivered Cognitive Behavioral Treatments (ICBTs) for specific phobia in order to understand which characteristics are important in online exposure scenarios. The aim of the present work was to conduct a feasibility pilot study to explore participants' opinions, preferences, and acceptability ratings of two types of images (still images vs 360° navigable images) in an ICBT for Flying Phobia (FP). A secondary aim was to test the potential effectiveness of the two active treatment arms compared to a waiting list control group. An exploratory aim was to compare the role of navigable images vs. still images in the level of sense of presence and reality judgment and explore their possible mediation in treatment effectiveness.MethodsParticipants were randomly allocated to three conditions: NO-FEAR Airlines with still images (n = 26), NO-FEAR Airlines with still and navigable images (n = 26), and a waiting list group (n = 26). Primary outcome measures were participants' opinions, preferences, satisfaction, and acceptance regarding the images used in the exposure scenarios. Secondary outcome measures included FP symptomatology outcomes and measures of sense of presence and reality judgment.ResultsParticipants in the study preferred navigable images over still images before and after treatment (over 84%), and they considered them more effective and logical for the treatment of their problem. However, adherence in the experimental conditions was low (42.3% dropout rate), and more participants withdrew from the group that included navigable images compared to the group that only included still images (14 vs. 8), with no statistical differences in attrition between the two conditions. NO-FEAR Airlines proved to be effective in reducing FP symptomatology compared to the control group, with large between-group effect sizes on all FP measures (ranging from 0.76 to 2.79). No significant mediation effect was found for sense of presence or reality judgment in treatment effectiveness.DiscussionThe results of the current study suggest that participants prefer more immersive images in exposure scenarios, providing data that can help to design useful exposure scenarios to treat specific phobias in the future. They also provide evidence supporting the effectiveness of an ICBT for FP.Trial registrationRegistered at Clinicaltrials.gov (NCT03900559) on April 9, 2019. Retrospectively registered.

Project description:BackgroundDental phobia (DP) and injection phobia (IP) are common in children and adolescents and are considered some of the biggest obstacles to successful treatment in pediatric dentistry. Cognitive behavioral therapy (CBT) is an evidence-based treatment for anxiety and phobias. As the availability of CBT in dentistry is low, internet-based CBT (ICBT) was developed. Open trials have shown that ICBT is a promising intervention, but randomized trials are lacking.ObjectiveThis randomized controlled trial tests whether therapist-guided ICBT supported by a parent could reduce fear, allowing children and adolescents with DP or IP to receive dental treatment.MethodsWe enrolled 33 participants (mean age 11.2, SD 1.9 y) whom a clinical psychologist had diagnosed with DP, IP, or both. After inclusion, participants were randomized to either ICBT (17/33, 52%) or a control group of children on a waitlist (16/33, 48%). ICBT was based on exposure therapy and comprised a 12-week at-home program combined with visits to their regular dental clinic. Participants corresponded weekly with their therapist after completing each module, and 1 parent was designated as a coach to support the child in the assignments during treatment. All participants completed measurements of the outcome variables before treatment start and after 12 weeks (at treatment completion). The measurements included a structured diagnostic interview with a clinical psychologist. Our primary outcome measure was the Picture-Guided Behavioral Avoidance Test (PG-BAT), which assesses the ability to approach 17 dental clinical procedures, and a positive clinical diagnosis. Secondary outcome measures included self-report questionnaires that measured self-efficacy and levels of dental and injection anxiety. The children and their parents completed the questionnaires.ResultsAll participants underwent the 12-week follow-up. After treatment, 41% (7/17) of the participants in the ICBT group no longer met the diagnostic criteria for DP or IP, whereas all participants in the control group did (P=.004). Repeated-measure ANOVAs showed that ICBT led to greater improvements on the PG-BAT compared with the control group; between-group effect sizes for the Cohen d were 1.6 (P<.001) for the child-rated PG-BAT and 1.0 (P=.009) for the parent-rated PG-BAT. Reductions in our secondary outcomes-dental fear and anxiety (P<.001), negative cognitions (P=.001), and injection fear (P=.011)-as well as improvements in self-efficacy (P<.001), were all significantly greater among children in the ICBT group than in the controls. No participants reported adverse events.ConclusionsICBT seems to be an effective treatment for DP and IP in children and adolescents. It reduced fear and anxiety and enabled participants to willingly receive dental treatment. ICBT should be seriously considered in clinical practice to increase accessibility; this therapy may reduce the need for sedation and restraint and lead to better dental health in children and adolescents.Trial registrationClinicalTrials.gov NCT02588079; https://clinicaltrials.gov/study/NCT02588079.

Project description:BackgroundThe financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.Methods/designThe study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).DiscussionPiloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website.Trial registrationThis trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13.

Dataset Information

An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial.

Publications

An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial.

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