Abstract
BackgroundRecently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks.Methods/DesignA two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol.DiscussionTo our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults.Trial registrationGerman Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).
Highlights
Internet-based interventions have been proposed as effective treatments for people with panic disorder (PD)
To our knowledge, this randomized controlled trial (RCT) is one of the first to examine the efficacy of a hybrid online training for adult PD
The cost-effectiveness analysis will indicate whether online training is an economical tool for treating PD among adults
Summary
Internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). PD (with or without agoraphobia) is associated with a high psychiatric comorbidity, lower quality of life, and severe work impairment [4,5], and places a significant burden on healthcare systems [2,6] Psychotherapeutic treatments such as cognitive behavioral therapy (CBT) are effective for PD [7]. Only 16.7% of people who suffer from anxiety disorders seek help from a mental health professional, and of these individuals, only 21.3% receive CBT, which is arguably the most effective treatment [8]. The reasons for this low endorsement of effective PD treatments include a lack of psychoeducation, a fear of stigmatization, and structural barriers such as a lack of access to adequate treatments [9,10]
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