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Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial.

Ebenfeld L, Kleine Stegemann S, Lehr D, Ebert DD, Jazaieri H, van Ballegooijen W, Funk B, Riper H, Berking M - Trials (2014)

Bottom Line: However, little is known about the clinical effects of integrating mobile technology into these interventions.Moreover, a cost-effectiveness analysis will be performed from a societal perspective.The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults.

View Article: PubMed Central - PubMed

Affiliation: Division of Health Training Online, Leuphana University Lueneburg, Innovation Incubator, Rotenbleicher Weg 67, 21335 Lueneburg, Germany. ebenfeld@inkubator.leuphana.de.

ABSTRACT

Background: Recently, 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/design: A 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.

Discussion: To 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 registration: German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

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Related in: MedlinePlus

App screenshots of GET.ON PANICAPP. The app supports in vivo exposures. Participants start with ranking their anxiety provoking situations in a hierarchical order. Furthermore, they are asked to answer questions about their anxiety before and after performing the exposure exercise (for example the level of anxiety, the degree of avoidance and the severity of body symptoms). In addition, they have the ability to take a photo after an in vivo exposure exercise is completed. The bar chart in the end offers graphical feedback to the participants regarding the exposure performance.
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Fig2: App screenshots of GET.ON PANICAPP. The app supports in vivo exposures. Participants start with ranking their anxiety provoking situations in a hierarchical order. Furthermore, they are asked to answer questions about their anxiety before and after performing the exposure exercise (for example the level of anxiety, the degree of avoidance and the severity of body symptoms). In addition, they have the ability to take a photo after an in vivo exposure exercise is completed. The bar chart in the end offers graphical feedback to the participants regarding the exposure performance.

Mentions: GET.ON PANIC is a hybrid internet-based self-help intervention with minimal therapeutic guidance based on CBT principles[18, 44–46]. The hybrid online training consists of two components: a browser-based section (desktop PC or laptop) and a mobile application (smartphone app). The intervention is divided into six modules: psychoeducation, interoceptive exposure, in vivo exposure, two modules of cognitive restructuring, and relapse prevention (see Table 1). Using responsive web design, participants can use the program on a desktop PC, a laptop, a tablet, or a smartphone. An integrated read-aloud function allows participants to follow the lessons via audio narration. The app addresses interoceptive and in vivo exercises as well as diary and relaxation exercises. Detailed information about the development of the app can be found in the paper by Kleine Stegemann et al.[47].In the first module, participants will receive an overview of the different modules and the practical procedure of the online training. Information about PD will be provided, and personal goals will be defined. In addition, a mobile diary will be introduced to the participants. The emphasis of the second module is interoceptive exposure. The theoretical background of the relationship between bodily symptoms and anxiety will be provided in an interactive way with videos and writing exercises. The app contains three interoceptive exposure packages, each consisting of four different tasks. In module three, participants will rank their individual anxiety provoking situations in a hierarchy before beginning the app-assisted in vivo exposures (see Figure 2). In addition, participants will continue with the second of the interceptive exposure exercises, which address dizziness.Table 1


Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial.

Ebenfeld L, Kleine Stegemann S, Lehr D, Ebert DD, Jazaieri H, van Ballegooijen W, Funk B, Riper H, Berking M - Trials (2014)

App screenshots of GET.ON PANICAPP. The app supports in vivo exposures. Participants start with ranking their anxiety provoking situations in a hierarchical order. Furthermore, they are asked to answer questions about their anxiety before and after performing the exposure exercise (for example the level of anxiety, the degree of avoidance and the severity of body symptoms). In addition, they have the ability to take a photo after an in vivo exposure exercise is completed. The bar chart in the end offers graphical feedback to the participants regarding the exposure performance.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4233107&req=5

Fig2: App screenshots of GET.ON PANICAPP. The app supports in vivo exposures. Participants start with ranking their anxiety provoking situations in a hierarchical order. Furthermore, they are asked to answer questions about their anxiety before and after performing the exposure exercise (for example the level of anxiety, the degree of avoidance and the severity of body symptoms). In addition, they have the ability to take a photo after an in vivo exposure exercise is completed. The bar chart in the end offers graphical feedback to the participants regarding the exposure performance.
Mentions: GET.ON PANIC is a hybrid internet-based self-help intervention with minimal therapeutic guidance based on CBT principles[18, 44–46]. The hybrid online training consists of two components: a browser-based section (desktop PC or laptop) and a mobile application (smartphone app). The intervention is divided into six modules: psychoeducation, interoceptive exposure, in vivo exposure, two modules of cognitive restructuring, and relapse prevention (see Table 1). Using responsive web design, participants can use the program on a desktop PC, a laptop, a tablet, or a smartphone. An integrated read-aloud function allows participants to follow the lessons via audio narration. The app addresses interoceptive and in vivo exercises as well as diary and relaxation exercises. Detailed information about the development of the app can be found in the paper by Kleine Stegemann et al.[47].In the first module, participants will receive an overview of the different modules and the practical procedure of the online training. Information about PD will be provided, and personal goals will be defined. In addition, a mobile diary will be introduced to the participants. The emphasis of the second module is interoceptive exposure. The theoretical background of the relationship between bodily symptoms and anxiety will be provided in an interactive way with videos and writing exercises. The app contains three interoceptive exposure packages, each consisting of four different tasks. In module three, participants will rank their individual anxiety provoking situations in a hierarchy before beginning the app-assisted in vivo exposures (see Figure 2). In addition, participants will continue with the second of the interceptive exposure exercises, which address dizziness.Table 1

Bottom Line: However, little is known about the clinical effects of integrating mobile technology into these interventions.Moreover, a cost-effectiveness analysis will be performed from a societal perspective.The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults.

View Article: PubMed Central - PubMed

Affiliation: Division of Health Training Online, Leuphana University Lueneburg, Innovation Incubator, Rotenbleicher Weg 67, 21335 Lueneburg, Germany. ebenfeld@inkubator.leuphana.de.

ABSTRACT

Background: Recently, 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/design: A 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.

Discussion: To 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 registration: German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

Show MeSH
Related in: MedlinePlus